Operator Manual
53 Pages
Preview
Page 1
Manufactured in the United States by AngioDynamics, Inc.
MAN/31/0075 US Version 4.0
2014-07
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
DIODE LASER OPERATORS MANUAL
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
AngioDynamics, Inc.
MAN/31/0075 US
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VenaCure 1470 Laser Operator's Manual
Version 4.0
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
SECTION 1 | WELCOME Thank you for purchasing an AngioDynamics* VenaCure* 1470 laser. This is a high quality medical instrument that will give many years of service if used and cared for according to the instructions in this operator manual.
INTRODUCTION This manual describes the operation of the VenaCure 1470 laser. This product is to be used only by experienced, trained operators familiar with laser procedures. Before using this instrument for the first time, read the Safety & Warnings (Section 2) and the Operating Instructions (Section 3).
The operator must become familiar with all the controls before commencing any therapy. The VenaCure 1470 laser is a diode laser capable of delivering up to 12 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture. The VenaCure 1470 laser incorporates a Class 4 (IV) InP (Indium Phosphide) diode laser with a wavelength of 1470 nm (±20 nm). The VenaCure 1470 laser incorporates a visible Class 3R (IIIa) diode laser aiming beam with a wavelength of 635-660 nm and a maximum power output of 5 mW.
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Before going any further it is important that the Product Information on page 5 is completed at installation for future reference. The Warranty Form in the accompanying Warranty Booklet must also be filled in and the form returned to AngioDynamics to complete the registration process.
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
DESCRIPTION OF THE VENACURE 1470 LASER The VenaCure 1470 laser has been designed for use with the AngioDynamics range of VenaCure EVLT* procedure kits for Endovenous Laser Treatment. The VenaCure 1470 laser system consists of three main components: •
The main enclosure houses the laser module containing the optics, heatsink, microprocessor-based control electronics and power supplies
•
The footswitch to activate the laser output when in READY mode
•
The fiber for delivering the laser radiation (sold separately)
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
Key features of the VenaCure 1470 laser include: •
12 W power output
•
Compact & portable
•
Intuitive user interface
•
Automatic fiber recognition for use with the AngioDynamics Endovascular Laser procedure kits
•
Minimal maintenance & service
•
Memory card slot for transfer of data between the VenaCure 1470 laser and a PC
ABOUT THIS MANUAL This manual is broken down into six sections as described below. 1
Welcome
2
Safety & Warnings
Explains the general warnings and precautions that must be followed to ensure that the VenaCure 1470 is used in a safe manner.
3
Operating Instructions
Provides detailed instructions on how to install and operate the VenaCure 1470 laser.
4
Maintenance & Troubleshooting
Explains all the maintenance procedures that can be performed by the user and troubleshooting guidelines.
5
Technical Information
Includes technical information about the VenaCure 1470 laser.
6
Warranty
Contains the AngioDynamics warranty policy.
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VenaCure 1470 Laser Operator's Manual
PRODUCT INFORMATION Laser Serial Number
Date Installed...
Installed by...
Signed ...
Print Name ...
Organization...
For service, parts or repair, contact your local AngioDynamics representative.
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Software Version... (Note: This is shown on the screen displayed at start-up.)
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
Table of Contents SECTION 1 | WELCOME... 3 INTRODUCTION ... 3 DESCRIPTION OF THE VENACURE 1470 LASER... 4 ABOUT THIS MANUAL... 4 PRODUCT INFORMATION... 5 SECTION 2 | SAFETY & WARNINGS... 9 SYMBOLS USED IN THIS MANUAL... 9 SYMBOLS USED ON ANGIODYNAMICS PRODUCTS... 9 WARNINGS...11 EMC WARNING...11 SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS... 12
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
EYE INJURY... 14 BURNS... 14 REFLECTION WARNING... 14 EXPLOSION HAZARD WARNING... 14 VAPOUR PLUME... 14 CLINICAL INDICATIONS & CONTRAINDICATIONS... 15 CLINICAL WARNINGS... 15 CLINICAL PRECAUTIONS... 16 SAFETY LABELLING... 16 SAFETY FEATURES... 17 EMC DECLARATION... 18 ESD PRECAUTIONARY PROCEDURES... 21 ESSENTIAL PERFORMANCE... 21 FCC DECLARATION... 21 SECTION 3 | OPERATING INSTRUCTIONS... 23 INTRODUCTION... 23 CONVENTIONS... 23 SUMMARY... 23 INSTALLATION AND SET-UP... 24 FRONT PANEL CONTROLS ... 26 REAR PANEL CONTROLS... 28 FIBER RECOGNITION SYSTEM... 30 OPERATING INSTRUCTIONS... 31 EMERGENCY OVERRIDE... 35 SET-UP MENU... 36 STATISTICS... 40
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SECTION 4 | MAINTENANCE & TROUBLESHOOTING... 43 CLEANING... 43 CARING FOR FIBERS... 43 STERILIZATION OF OPTICAL FIBERS... 43 FUSE REPLACEMENT... 44 DISPOSAL... 44 SOFTWARE UPDATES ... 44 SERVICING... 44 LASER POWER OUTPUT... 44 TROUBLESHOOTING... 46 SECTION 5 | TECHNICAL INFORMATION... 49 SPECIFICATIONS... 49 ACCESSORIES... 50 TECHNICAL DESCRIPTION... 50 SECTION 6 | Warranty... 53 MANUFACTURER’S Warranty POLICY... 53
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CLASSIFICATION... 49
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
AngioDynamics, Inc.
MAN/31/0075 US
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VenaCure 1470 Laser Operator's Manual
Version 4.0
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
SECTION 2 | SAFETY & WARNINGS SYMBOLS USED IN THIS MANUAL This symbol indicates caution should be taken, as there may be a potentially hazardous situation that could result in injury to personnel or damage to the equipment. CAUTION This symbol indicates the possibility of a non-radiation hazard that may result in severe injury to personnel within the vicinity of the equipment. WARNING This symbol indicates the possibility of an electrical hazard that could cause injury to personnel within the vicinity of the equipment or damage to the equipment. WARNING This symbol indicates the possibility of exposure to hazardous laser radiation that could cause injury to personnel within the vicinity of the equipment. WARNING This symbol indicates personnel within the vicinity of the equipment should wear appropriate eye protection. This symbol indicates an important point to be noted.
SYMBOLS USED ON ANGIODYNAMICS PRODUCTS The following symbols are used on the VenaCure 1470 laser and on accessories provided by AngioDynamics. Consult instructions for use Follow instructions for use Caution, consult accompanying documents Power Off Power Off (for part of equipment) Power On Power On (for part of equipment) Type B applied part (optical fiber) MAN/31/0075 US
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Intentional radiator Temperature Limitation Humidity Limitation This way up Stacking limit by Mass Use No Hand Hooks
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
Fragile Keep Dry Keep away from sunlight Atmospheric Pressure Limitation Separate Collection
Non-sterile NON STERILE
For single use only. Do not re-use. Do not use if package is damaged Use By
LOT
REF
UPN STERILE EO
Batch number Catalog Number Product Number Sterilized using Ethylene Oxide Legal Manufacturer
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VenaCure 1470 Laser Operator's Manual
WARNINGS US Federal Law restricts the use of this device to sale by or on the order of a physician. Intended for use only by trained physicians/surgeons familiar with laser procedures. CAUTION No modification of this equipment is allowed.
WARNING Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
This product must be stored at temperatures between 0°C (32°F) and 55°C (131°F). If stored at temperatures outside these limits for a period of time, the laser requires up to 12 hours to acclimatize, prior to operation. CAUTION
Failure to observe this could result in invalidation of the warranty. If the product has been stored at a temperature above 30°C (86°F), the laser’s cooling system may take a few minutes to stabilize after it has been switched on.
CAUTION
A message will be displayed on the screen to indicate this. The laser is not designed to operate at temperatures below 10°C (50°F) or above 30°C (86°F).
CAUTION This product contains a lithium battery, which should only be replaced by authorized service personnel. CAUTION Additional labelling should not be placed on the equipment, where it may obscure the display and/or warning labels. CAUTION
EMC WARNING Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. The VenaCure 1470 laser complies with the requirements of applicable EMC standards. The VenaCure 1470 laser may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. The VenaCure 1470 laser must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected by this emission. Portable and mobile RF communications equipment can affect medical electrical equipment. The VenaCure 1470 laser should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the VenaCure 1470 laser should be observed to verify normal operation in the configuration in which it will be used. MAN/31/0075 US
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WARNING
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
If electromagnetic interference is experienced, relocate or re-orientate the VenaCure 1470 laser or the other equipment. Accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the VenaCure 1470 laser as replacement parts for internal components, may result in increased emissions or decreased immunity of the VenaCure 1470 laser. ‘Immunity’ is the ability of a device to function normally when operated in the presence of electromagnetic radiation. For details of compatible accessories for the VenaCure 1470 laser, see the list within Section 5. If a remote interlock lead is required, it must be constructed using the following materials or direct equivalents: •
Remote Interlock Lead (if required): Lemo connector (supplied with laser): AngioDynamics part number: CON/51/0003 Ferrite sleeve (Farnell part number: 898-454). Screened twisted pair cable 7/0.2 (Farnell part number: 140-457), maximum length 4 m (13 ft).
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
Note: The ferrite sleeve should be fitted to the remote interlock cable, at a maximum of 75 mm (3 inches) from the Lemo connector.
SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS The VenaCure 1470 laser is classified as a Class 4 (IV) laser product in compliance with FDA 21 CFR 1040.10 and 1040.11, UL 60601-1, EN 60601-1, EN 60601-1-2, EN 60601-2-22 and EN 60825-1.
The local Laser Safety Officer should review all procedures for safety prior to system use.
WARNING
WARNING
A Class 4 (IV) Laser is hazardous to the eye from the direct beam and diffuse reflections. It also presents significant skin and fire hazard.
Avoid eye or skin exposure to direct or scattered radiation. Take all necessary protective measures, as explained in the rest of this section, in areas where the laser is being used.
All personnel must wear approved protective glasses appropriate to the wavelength of the VenaCure 1470 to reduce the risk of eye damage.
WARNING
The aiming beam is a Class 3R (IIIa) laser and an unprotected eye may view the beam scattered from a non-reflective surface. Do not stare into the aiming beam or view it directly with optical instruments.
Avoid directing the laser beam anywhere other than the treatment area or calibration ports. WARNING
WARNING MAN/31/0075 US
Before using a fiber, check it carefully for any signs of damage during storage or transit. Protective caps should be in place over SMA connectors. All screws and ports should be secure. Do not use if there is any sign of damage.
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WARNING
WARNING
CAUTION
CAUTION
WARNING
WARNING
CAUTION
The VenaCure 1470 laser is a portable laser weighing up to 12 kg (26 lb). All standard safety procedures for lifting should be applied when moving the instrument.
There are no user serviceable parts in the VenaCure 1470 laser. The exterior cover should only be removed by a trained and authorized laser service technician.
To avoid the risk of electric shock, the equipment must only be connected to a supply mains with protective earth.
The VenaCure 1470 laser is suitable for continuous operation in normal conditions. To prevent overheating and improper operation, do not obstruct the cooling vents or place the VenaCure 1470 laser in a location with poor ventilation or high ambient temperature.
The VenaCure 1470 laser uses heat as part of its function. The fiber may reach temperatures in excess of 41°C.
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
Always switch off the VenaCure 1470 laser at the rear power switch and disconnect the electrical power cord from the AC supply before performing any of the cleaning or maintenance procedures described below.
Any attempts to repair, adjust or modify the laser beyond the procedures allowed in this Operator Manual, by any person not authorised by AngioDynamics, will invalidate the warranty. Pins of connectors identified with the Electrostatic Discharge (ESD) warning symbol should not be touched. Connections should not be made to these connectors unless the ESD precautionary procedures detailed in the ESD Precautionary Procedures are followed. It is recommended that all staff receive an explanation of the ESD warning symbol and made aware of the ESD precautionary procedures described at the end of this section.
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CAUTION
VenaCure 1470 Laser Operator's Manual
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
EYE INJURY Extreme caution should be taken when operating the VenaCure 1470 near the eyes. WARNING All personnel must wear approved protective glasses to reduce the risk of eye damage. The patient should wear protective glasses. WARNING
The local Laser Safety Officer should review all procedures for safety prior to system use. All protective glasses should be designed for protection from continuous wave laser radiation in the wavelength range 1440 – 1500 nm. The degree of optical filtration (Optical Density or OD) depends on the application and should be assessed and approved by the appointed Laser Safety Officer for the establishment.
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
The recommendations of European Standards EN 60825-1 or EN 207 are appropriate to assessing laser eye risk. Note that the standards assume a viewing distance from the source of light of more than 100 mm (4 inches). AngioDynamics supplies laser safety glasses marked in accordance with EN 207 as L3 or greater. Contact your local AngioDynamics representative if these are required. The ‘Nominal Ocular Hazard Distance’ is 0.31 m (1 foot). Use of optical accessories and viewing aids, which may increase the eye exposure beyond a safe limit, should be subject to the approval of the Laser Safety Officer.
WARNING
Never look directly into the laser aperture even if wearing safety glasses. Serious eye injury could result.
BURNS Irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn. WARNING
REFLECTION WARNING Avoid placing reflective materials such as glass, metals and polished plastic in the beam. WARNING
EXPLOSION HAZARD WARNING The VenaCure 1470 laser is not intended for use in oxygen-rich environments.
WARNING
Do not use flammable or explosive anesthetic gases that may be ignited by the laser as the VenaCure 1470 laser is not protected against hazards of ignition of flammable anaesthetic mixtures.
VAPOUR PLUME AngioDynamics recommends that a smoke evacuator or in-line filter be used when lasing. CAUTION
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VenaCure 1470 Laser Operator's Manual
CLINICAL INDICATIONS & CONTRAINDICATIONS Indications
The VenaCure 1470 laser is intended for use in delivering up to 12 Watts of continuous wave or pulsed radiation with AngioDynamics EVLT Procedure Kits in endovascular coagulation of the Greater Saphenous Vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recommended power range is between 5 W and 7 W. A specific level is not recommended, but is left to user preference and best medical judgement.
Potential Complication
The VenaCure 1470 laser is contraindicated for: •
Patients with thrombus in the vein segment to be treated
•
Patients with an aneurysmal section in the vein segment to be treated
•
Patients with peripheral artery disease as determined by an Ankle-Brachial Index < 0.9
The potential for complications exists, including: •
Vessel Perforation
•
Thrombosis
•
Pulmonary Embolism
•
Phlebitis
•
Hematoma
•
Infection
•
Skin Pigmentation Alteration
•
Neovascularization
•
Paresthesia due to thermal damage of adjacent sensory nerves
•
Anesthetic Tumescence
•
Non-Target Irradiation
•
Hemorrhage
•
Necrosis
•
DEHP Exposure
•
Skin Burns and Pain
(This is not an exhaustive list.)
CLINICAL WARNINGS As with any conventional surgical operations, adverse reactions may occur following treatment. WARNING
Use cautiously with patients who have had difficulty with previous laser procedures. WARNING
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Contraindications
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
CLINICAL PRECAUTIONS General Precautions
CAUTION
Only operators who have been trained in the use of lasers and are thoroughly familiar with this Operator Manual should use the VenaCure 1470 laser. The information provided in this section is not intended to be all-inclusive and it is not intended to replace operator training or experience. Please contact your AngioDynamics representative for training materials available on the use of this equipment. Specific parameters are not recommended, but are left to operator preference and best medical judgment.
SAFETY LABELLING Location of Safety Labelling
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
Safety labels for the VenaCure 1470 are positioned as indicated below.
STOP
Aperture Label (Visible when aperture cover is open) Safety Label
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VenaCure 1470 Laser Operator's Manual
Product Identification Labelling Product identification labelling is located on the rear of the VenaCure 1470. This device contains an intentional radiator part number AS/0670 FCC ID: RBQAS0670 This product complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Canada IC: 4690A-AS0670 This device complies with Canadian RSS-210
AngioDynamics VenaCure 1470
Manufactured in the USA by: AngioDynamics, Inc. 603 Queensbury Ave. Queensbury, NY 12804, USA
Serial Number: VenaCure 009999
Date of Manufacture: Sept 2012
EC REP
This product complies with 21 CFR 1040.10 and 1040.11, UL60601-1, EN60601-1, 60601-2-22, 60825-1
IP21
AngioDynamics Netherlands BV Haaksbergweg 75 1101 BR Amsterdam The Netherlands
IOIOI
PP/1149 0086
GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED ‘HOSPITAL ONLY’ OR ‘HOSPITAL GRADE’
0 I
SAFETY FEATURES The VenaCure 1470 laser includes a number of safety features, which are provided in accordance with the requirements of the appropriate standards. •
protective housing
•
remote interlock bypass
•
key switch
•
laser radiation emission indicator, visible and audible
•
READY and STANDBY modes
•
manual reset mechanism
•
shutter (not mechanical)
•
emergency switch
•
location of controls
•
safety labels (see diagram)
•
identification and compliance label (see diagram)
•
aiming beam
The VenaCure 1470 laser is equipped with the following additional safety features: •
self-test
•
laser condition monitoring
•
pulse duration monitoring
•
power diodes watch-dog
•
microprocessor watch-dog
•
mains power fail protection
•
power supply monitor
•
temperature monitors
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100-240V 500VA 50-60Hz 2 x T6.3A H 250V
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
EMC DECLARATION Guidance and manufacturer’s declaration – electromagnetic emissions The VenaCure 1470 is intended for use in the electromagnetic environment specified below. The customer or user of the VenaCure 1470 should ensure it is used in such an environment. Compliance
Electromagnetic emissions – guidance
RF emissions CISPR 11
Group 1
The VenaCure 1470 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions IEC 61000-3-3
Not applicable
The VenaCure 1470 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 used for domestic purposes.
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Emissions test
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Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment – Guidance
Electrostatic discharge (ESD) IEC 61000-4-2
+/-6 kV contact
+/-6 kV contact
+/-8 kV air
+/-8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
+/-2 kV for power supply lines
+/-2 kV for power supply Mains power quality lines should be that of a typical commercial or hospital environment. +/-1 kV for input/output lines
Electrical fast transient / burst IEC 61000-4-4
+/-1 kV for input/output lines Surge IEC 61000-4-5
+/-1 kV differential mode
+/-2 kV common mode <5% UT (>90% dip in UT) Voltage Dips, short interruptions and for 0,5 cycle voltage variations on power supply input lines IEC 61000-4-11 40% UT (90% dip in UT) for 5 cycles
<5% UT (>95% dip in UT) for 5 s
<5% UT (>90% dip in UT) Mains power quality for 0,5 cycle should be that of a typical commercial or hospital environment. If the user 40% UT (90% dip in UT) of the VenaCure 1470 laser requires continued for 5 cycles operation during mains interruptions, it is recommended that the 70% UT (30 % dip in UT) VenaCure 1470 laser for 25 cycles be powered from an uninterruptible power supply or battery. <5% UT (>95% dip in UT) for 5 s
3 A/m
3 A/m
70% UT (30 % dip in UT) for 25 cycles
Power frequency (50/60 Hz) IEC 61000-4-8
+/-1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment. +/-2 kV common mode
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the AC mains voltage prior to application of the test level.
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The VenaCure 1470 laser is intended for use in an electromagnetic environment specified below. The customer or the user of the VenaCure 1470 laser should assure that it is used in such an environment.
AngioDynamics, Inc.
VenaCure 1470 Laser Operator's Manual
Guidance and manufacturer’s declaration – electromagnetic immunity The VenaCure 1470 laser is intended for use in an electromagnetic environment specified below. The customer or the user of the VenaCure 1470 laser should assure that it is used in such an environment. Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the VenaCure 1470 laser, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
AngioDynamics, Master Manual Template 8.5 in 11in, 156T8511 Rev/Ver. A, Manual, VenaCure 1470 Laser Operators Manuel, MAN/31/0075-US Ver 4.0
Recommended separation distance. Conducted RF IEC 61000-4-6
3 Vrms
Radiated RF IEC 61000-4-3
3 V/m
3 Vrms
d = 1.2 √P
3 V/m
d = 1.2 √P 80 MHz to 800 MHz
150 kHz to 80 MHz
80 MHz to 2,5 GHz
d = 2.3 √P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electronic 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. a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephone and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VenaCure 1470 laser is used exceeds the applicable RF compliance level above, the VenaCure 1470 laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VenaCure 1470 laser.
b
Over the frequency range 150 kHz to 800 MHz, field strengths should be less than 3 V/m
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