FAQ
NICO Myriad™ Console Operator’s Manual
Please read all information carefully. Failure to properly follow these instructions may lead to unintended surgical consequences. Important: This package insert is designed to provide instructions for use for the NICO Myriad handpiece. It is not a reference to surgical techniques.
Warnings and Cautions
WARNING:
To prevent fi re or shock hazard, do not expose the console to rain or moisture.
CAUTION:
To prevent electric shock, do not use the polarized plug with an extension cord, receptacle or other outlet unless the blades can be fully inserted to prevent blade exposure.
WARNING:
Use only components with this product that are manufactured by NICO Corporation (NICO) and intended for use with the NICO Myriad System. Use of any other systems’ components will void all warranti es and may result in system damage.
CAUTION:
Risk of electric shock - do not open console. To reduce the risk of electric shock, do
not remove cover. No user serviceable parts inside. Refer servicing to NICO Customer
Service (CS@niconeuro.com).
Additional Warnings and Precautions
  • The Myriad requires special precautions concerning EMC and needs to be installed and put into service according to the EMC information provided in this document.
  • Portable and mobile RF communications equipment can aff ect the Myriad.
  • The Myriad is intended for use by healthcare professionals only. The Myriad may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take miti gation measures, such as reorienti ng or relocati ng the Myriad or shielding its location.
  • Use of accessories and cables other than those specifi ed, with the exception of accessories and cables qualifi ed and sold by NICO, may result in increased emissions or decreased immunity of the equipment and may cause the Myriad to be noncompliant with the requirements of IEC 60601-1-2
  • The Myriad should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the confi guration in which it will be used.
  • Minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques. Consult medical literature relati ve to techniques, complications, and hazards prior to performance of any minimally invasive procedure.
  • If minimally invasive instruments and accessories from diff erent manufacturers are employed together in a procedure, verify compati bility prior to initi ation of the procedure.
  • Do not immerse electrosurgical instruments in liquid.
  • Take care not to step on wires and/or tubing connecti ng console to handpiece during procedures as this may result in compromised functionality and/or unexpected behavior of the Myriad handpiece.
  • It is important that the proper collection canister be used to prevent fl uid breach into the NICO Myriad Console. The canister should not be overfi lled – the level of fl uid in the canister should be monitored and the canister should be replaced when it is full. Only use collection canisters as specifi ed by NICO Corporation. See specifi cations section of this manual for additional details. In the event of fl uid breach into the NICO Myriad Console, disconti nue use immediately and contact NICO Corporation to arrange servicing.
  • This system should be used only by physicians trained in open or endoscopic ti ssue removal procedures.
  • Products manufactured or distributed by companies not authorized by NICO Corporation may not be compati ble with the NICO Myriad System. Use of such products may lead to unanti cipated results and possible injury to the user or pati ent.
  • Instruments or devices which come into contact with bodily fl uids may require special disposal handling to prevent biological contamination.
  • Dispose of all single pati ent use instruments whether used or unused. Do Not Resterilize any NICO device or accessory if its labeling indicates that it is for single use only. Resterilization of any single use disposable device may compromise the integrity and mechanical function of the instrument or accessory which may result in unintended injury or unacceptable clinical result.
  • Should any object or liquid fall into the console, unplug it and have it checked by qualifi ed personnel before further operation.
  • Allow adequate air circulation to prevent internal heat build-up. Do not place the console on surfaces or near materials that may prevent proper venti lation.
  • Do not install the console in a location near heat sources such as radiators or air ducts, and do not place console in direct sunlight. Isolate console from excessive dust, mechanical vibration or shock.
  • Periodically wipe off the console with a soft cloth and a common hospital cleaning solution (including cables if necessary). Stains may be removed with a cloth, lightly dampened with a mild detergent solution. Never use strong solvents or abrasive cleansers as these may damage the enclosure. As a safety precaution, unplug the console before wiping it off .
  • Do not place the console on any unstable surfaces which may not properly support it. The console may fall resulti ng in injury and/or product damage. Use only with a cart, stand or table recommended by the manufacturer or sold with the console. A console and cart combination should be moved with care. Quick stops, excessive force and uneven surfaces may cause the console and cart combination to overturn.
  • Grounding reliability can only be achieved when this equipment is connected to an equivalent receptacle marked “Hospital Grade.”
  • This product is for use only by qualifi ed medical personnel trained for its use.
  • DANGER: Risk of explosion if used in the presence of fl ammable anestheti cs.
  • If the unit has been subjected to a sudden temperature change, moisture may form on the metal inside the unit. If such a temperature change has occurred, allow the unit to achieve room temperature prior turning the unit on.
  • Do not damage or modify the power cord. Damage to the power cord may cause a fi re or shock hazard. When unplugging the power cord, always hold by the plug and remove it carefully.
  • When not in use, unplug the console from the electrical outlet.
  • When the console is not being used, store it in a location where it will not be damaged.
  • Only ship the console in packaging that has been approved by NICO. Alternate packaging will not guarantee the protection of the device during shipping.
  • Consult your NICO sales representati ve or Customer Service if you can’t correct a problem using this operator’s manual.
  • iconThe lightning fl ash with arrowhead symbol within an equilateral triangle is intended to alert the user to the presence of un-insulated dangerous voltage within the product’s enclosure that may be of suffi cient magnitude to consti tute a risk of electric shock.
  • iconThe exclamation point within an equilateral triangle is intended to alert the user to the presence of important operati ng and maintenance (servicing) instructions in the literature accompanying the device.
NICO Myriad Console Manual
This manual is writt en for the medical personnel who will be responsible for operati ng the console. It is extremely important that the operator read and thoroughly understand the contents of this manual and follow the instructions contained herein for reliable, safe and effi cient operation of the console.
Indications for Use
For the resection of soft ti ssue abnormaliti es found in the central nervous system as determined appropriate by the surgeon.
Contraindications
The NICO Myriad System is contraindicated for those pati ents where increased risk or complications may be associated with the removal or biopsy of ti ssue based on the physician’s judgment. Pati ents receiving anti coagulant therapy or who may have bleeding disorders may be at increased risk.
Device Description
The NICO Myriad System consists of a sterile, single pati ent use handpiece designed to be uti lized only with an approved NICO console and foot pedal. Tissue resection with the handpiece occurs through the combination of aspiration and mechanical cutti ng action which consists of a non-moving (stationary) outer cannula with a reciprocati ng inner cutti ng blade. The handpiece incorporates a distal ti ssue removal aperture. The handpiece thumbwheel is used to manually turn and orient the ti ssue removal aperture as desired. The system may also be used in an “aspiration only” mode during which no cutti ng occurs.
Owner’s Record
console. Record these numbers in the spaces provided below. Refer to them whenever you call NICO Customer Service regarding this product.
NICO Myriad Console Introduction
Components (Included with Console)
  • Foot Pedal
  • Power Cord
  • Nitrogen Line
  • Aspiration Line (exits front of console)

For a list of additional components/accessories, please contact your sales representati ve.
Console Functions
Front Panel
  • System Power- Toggle to turn power to the system on or off . I=ON, O=OFF
  • Foot Pedal -Att achment site for the foot pedal cord to the console.
  • Prime Butt on - This butt on enables the user to prime the handpiece, which includes simultaneous acti vation of cutti ng and aspiration (NOTE: maximum aspiration occurs during priming, regardless of the position of the aspiration control dial). Priming will occur as long as the prime butt on is depressed. The indicator light above the prime butt on illuminates while the handpiece is being primed. The cutt er enable light, cutt er acti ve light and aspiration light will also illuminate while the handpiece is being primed.
  • Aspiration - Att achment site for the aspiration hose to the console. The other end of the hose att aches to the collection canister. The indicator light above att achment site illuminates during aspiration.
  • Aspiration Level Control Dial - The user can increase or decrease the maximum aspiration level achieved at full depression of the foot pedal using this dial.
  • Aspiration Level Indicator - Digital display indicates aspiration level in non-descript units ranging from 0 to 25.
  • Handpiece - Att achment site for the handpiece cord to the console. Indicator light above att achment site illuminates during cutti ng.
  • Cutt er Enable Butt on - This butt on enables/disables the cutti ng mode on the handpiece. The indicator light above this butt on indicates when cutti ng is enabled. An audible alert also indicates whether or not cutti ng is enabled. Two sequenti al tones indicate that cutti ng is enabled, while a single tone indicates that cutti ng is disabled.
Console Functions
Rear Panel
  • Power Cord Receptacle - Att achment site for detachable hospital grade power cord (IEC320).
  • Circuit Breaker - See “Circuit Breaker Reset” in Service and Maintenance section of this manual.
  • Rati ng Chart - Listi ng of the electrical specifi cations for the unit.
  • Duty Cycle Rati ng – When the cutt er is enabled, a duty cycle of 20% is applicable.
  • Nitrogen Supply Input - Att achment site for the nitrogen line to the console. The other end of the nitrogen line will att ach to the nitrogen source. The back of the console is fi tt ed with the male DISS nitrogen connector. The line is fi tt ed with a female DISS nitrogen connector at each end. If the OR nitrogen supply has a diff erent connection, adapters are available for purchase.
Console Connections
This section provides information for making all connections necessary to set up the console. The following connections will be covered:
  • Power Cord
  • Nitrogen Line
  • Aspiration Line
  • Canister
  • Foot Pedal
  • Handpiece
Power Cord Connection
The power cord connects the console to the building power supply. Insert the hospital grade power cord into the power cord receptacle on the rear panel (Figure 1). The power cord is to be used for mains disconnection.

Note: Ensure that the power cord is in good condition. A damaged power cord poses an electrical shock hazard. When unplugging the unit, always grasp the plug and pull gently. NEVER pull on the cord.
Nitrogen Line Connection
Supplied with the console is an 18 (+/- 1) foot nitrogen line with female DISS nitrogen fi tti ngs on each end. Insert one end of the nitrogen line into the male fi tti ng on the rear panel of the console (Figure 2). Tighten the connection by rotati ng the connection nut clockwise. The nitrogen line should be hand ti ghtened. Do not use tools to ti ghten the fi tti ngs. The opposite end of the hose should be connected to the hospital nitrogen supply. Before att aching the line to the hospital nitrogen supply, confi rm that the supply pressure does not exceed 100 psig, the recommended input supply pressure for the console. A DISS to Schrader adapter is available for Schrader connections. If the hospital nitrogen supply connection is neither DISS nor Schrader, contact the biomedical engineering department or call NICO Corporation Customer Service for technical support..
Aspiration Line Connection
Once nitrogen has been supplied to the console, the console will generate its own aspiration when acti vated by the foot pedal. The console includes a fl exible aspiration line that exits the front of the console (Figure 3). To connect the aspiration line to the console, fi rmly press the end of the tube into the fi tti ng. The tube should insert approximately 0.5 inches (13 mm).

The opposite end of the aspiration line includes a fl exible suction connector that is att ached to the vacuum port on the canister (Figure 4). Ensure that the lid and port caps are secure and sealed to avoid vacuum system leaks. Any leaks in the aspiration system will aff ect the performance of the NICO Myriad System.

If it is desired to collect the ti ssue removed during the procedure, a specimen collector must be used. Figure 5 illustrates the tubing connections to the canister lid with a specimen collector. During the set up/priming operation, the aspiration indicator on the console should read a minimum of 17. If the aspiration is below 17, check the aspiration system for leaks and confi rm that the nitrogen input supply pressure is correct.
Foot Pedal Connection
To connect the foot pedal to the console, insert the gray foot pedal connector into the gray receptacle on the console unti l it clicks into position (Figure 6) (NOTE: the foot pedal connector is keyed and will only connect to the console in one orientation). To remove the connector, pull back on the outer sleeve and withdraw from console receptacle.
Handpiece Connection
To connect the handpiece to the console, insert the blue handpiece connector into the blue receptacle on the console unti l it clicks into position (Figure 7) (NOTE: the handpiece connector is keyed and will only connect to the console in one orientation). To remove the connector, pull back on the outer sleeve and withdraw from console receptacle. Figure 8 illustrates the handpiece tubing connection directly to the canister lid, while fi gure 9 illustrates the handpiece tubing connection when a specimen collector is used.
Using the Console
System Power Up
Aft er making all necessary connections, turn the system power on by depressing the switch to the “I” position (Figure 10). At this point, the indicator light next to the power switch will illuminate, other indicator lights on the user face will blink, and a single beep will be heard from the console. The aspiration indicator will read zero.
Priming the System
Before using the system, it is required that each handpiece be primed by aspirati ng fl uid into the aperture, through the handpiece and tubing, and into the canister. This can be accomplished by depressing the prime butt on (Figure 11) while aspirati ng sterile fl uid from a small bowl or from the reservoir provided in the tray in which the handpiece was packaged. This will ensure that the inside of the handpiece and tubing are lubricated and will reduce the likelihood of ti ssue occlusions.
Aspiration and Cutting
The console off ers two modes of operation: (1) Aspiration only, and (2) Aspiration with Cutti ng.

This system is supplied with a two-stage foot pedal. The foot pedal consists of a large “main” foot pedal and a smaller “side-kick” foot pedal (Figure 12). When depressed, the large foot pedal will initi ate either aspiration only or aspiration with cutti ng (depending on whether or not cutti ng has been enabled). The side-kick foot pedal enables the user to toggle between these modes of operation by either enabling or disabling cutti ng. The user may also toggle between these two modes by depressing the cutt er enable butt on ( ) on the console.
Aspiration and Cutting
The console off ers two modes of operation: (1) Aspiration only, and (2) Aspiration with Cutti ng.

This system is supplied with a two-stage foot pedal. The foot pedal consists of a large “main” foot pedal and a smaller “side-kick” foot pedal (Figure 12). When depressed, the large foot pedal will initi ate either aspiration only or aspiration with cutti ng (depending on whether or not cutti ng has been enabled). The side-kick foot pedal enables the user to toggle between these modes of operation by either enabling or disabling cutti ng. The user may also toggle between these two modes by depressing the cutt er enable butt on ( ) on the console.


When cutti ng is enabled, depressing the large foot pedal will result in cutti ng action as well as aspiration. When cutti ng is disabled, depressing the large foot pedal will result in aspiration only. The level of aspiration delivered is proportional to the depth to which the foot pedal is depressed. Additionally, the aspiration dial on the console may be adjusted to control the maximum amount of aspiration delivered. A duty cycle of 20% is applicable when cutti ng is enabled as specifi ed below as well as on the back of the console.

Troubleshooting
This section provides guidance if problems are encountered when operati ng the console. Please consult the following information before contacti ng NICO to ensure the problem is not a misunderstanding of the operation of the system. If aft er reading this section the problem sti ll cannot be resolved, please contact NICO for technical support.
Problem Possible Cause Action
No system response Power cord not plugged in Check cord. Follow instructions
in “Console Connections” section of this manual.
No system response Circuit breaker tripped Reset circuit breaker on back of the console. Follow instructions in “Reset Circuit Breaker” section of this manual.
Handpiece not
aspirating/cuttng
Handpiece not plugged in Check handpiece. Follow
instructions in “Console
Connections” section of this
manual.
Handpiece not aspirating/cuttng; Aspiration line from console
or handpiece not
connected to canister
Check console aspiration line.
Follow instructions in “Console
Connections” section of this
manual.
Handpiece not aspirating/cuttng Canister lid not tight Check canister. Follow
instructions in “Console
Connections” section of this
manual.
Handpiece not aspirating/cuttng Foot pedal not plugged in Check foot pedal. Follow
instructions in “Console
Connections” section of this
manual.
Handpiece not aspirating/cuttng Aspiration tubing clogged Prime aspiration tubing. Follow
instructions in “Priming the
System” section of this manual.
Visually locate occlusion and
manually manipulate the
blockage while priming.
Service and Maintenance
The NICO Myriad System is covered by a one-year warranty for defects, materials and workmanship. Additional extended service contracts are available. Contact your NICO sales representati ve or NICO Corporation directly for details.
Circuit Breaker Reset
The circuit breaker is located on the rear panel of the console below the power cord receptacle.
  • Unplug console from the power source.
  • Disconnect power cord from receptacle on rear panel.
  • Allow 60 seconds for system to reset prior to proceeding to step 4.
  • Press the butt on on the circuit breaker to reset.
  • Plug the power cord to the console and into the power source.
Aspiration Line Replacement
To remove the aspiration line for replacement or shipping:
  • With thumb and forefi nger, press the ring at the junction of the aspiration line and aspiration line fi tti ng toward the NICO Myriad console.
  • While the ring is depressed, pull the aspiration line away from the console.
To replace the aspiration line:
  • Firmly press the end of the tube into the fi tti ng. The tube should insert approximately 0.5 inches (13 mm).
Inquiries and Service
Direct inquiries to your NICO Corporation sales representati ve or to:

NICO Corporation
Customer Service Department
9190 Priority Way West Drive, Suite 203
Indianapolis, IN 46240

Phone: 317-660-7118 ext.100

If your system requires service, contact NICO Corporation Customer Service at 317-
660-7118 ext.100. Customer Service will provide you with all necessary information
for returning and repairing your console.
Maintenance Schedule
Activity Occurrence Action
Wipe off console As needed Wipe off console with a clean towel moistened with a hospital approved solution
Wipe off foot pedal As needed Wipe off foot pedal with
a clean towel moistened
with a hospital approved
solution
Inspect foot pedal cord Annually Check for cuts and
damage to outside cover
and strain reliefs
Inspect power cord Annually Check for cuts and
damage to outside cover
Inspect nitrogen line Annually Check for cuts and
damage to outside cover
Test leakage current Annually Confirm that leakage
current is acceptable per
the requirements of the
applicable
hospital/facility
Specifications
NN-7000 NICO Myriad Console
Width 12.5 in. (318 mm)
Height 4.10 in. (104 mm)
Length 14.75 in. (375 mm)
Weight 15.50 Lbs. (7.0 kg)
Maximum Power 40 Watt s
AC Voltage Range 100-240 V
Frequency Range 50-60 Hertz
Max Current 0.2 Amps
Circuit Breaker 2.0 Amps, 250 V
Nitrogen Input Pressure Range 90-100 PSI (620-690 kPa)
Vacuum Generator 0-25.5 inHg (0-65 cmHg) [min. @ sea level]
Power Cord Length 15 feet (4.5 m) min.
Nitrogen Line Length 18 feet (5.5 m) min.
Hand Piece Cable Length 17 feet (5.2 m) min.
NN-7001 NICO Myriad Cart
Width 24 in. (610 mm)
Height 40 in. (1,195 mm)
Length 26.5 in. (673 mm)
Weight 47 lbs (21.32 kg)
Rear Casters Swivel, Locking
Front Casters Swivel, Non-locking
Handle Foldable
NN-7002 NICO Myriad Foot Pedal
Width 4.75 in. (121 mm)
Height 3.75 in. (95 mm)
Length 11.875 in. (302 mm)
Weight 6.7 lbs. (3.0 kg)
Cord Length 17 feet (5.2 m)
NN-7003 NICO Myriad DISS/Schrader Adapter
Type Non-Swivel Nitrogen X DISS 1120-A Male
Height 4.05 in
Length 0.27 lbs (123.73 grams)
NN-7010 NICO Myriad DISS/Schrader Swivel Adapter
Type Swivel Air X DISS Nitrogen 1120-A Male
Height 4.05 in
Length 0.27 lbs (123.73 grams)
NN-7005 NICO Myriad Nitrogen Line
Length 18 feet (5.5 m)
Color Black
NN-7006 NICO Myriad Power Cord
Length 15 feet (4.5 m)
Color Gray
NN-9004 Aspiration Line
Length 20 in. (508 mm)
Color Blue
NN-9001 Hi Flow Suction Canister
Volume 800 cc (ml)
Lid Light green, includes check valve
Classifi cation
Class I, Type BF Applied Part
Conti nuous Mode of Operation
Console: IPX0 (Ordinary)
Foot Pedal: IPX8
Console Shipping and Storage
Temperature range within -29°C to +60°C
Relati ve humidity range within 30% to 85%
Atmospheric pressure range within 500 to 1060hPa
Console Equipment Operati ng Environmental Conditions
Temperature range within 10°C to 40°C
Relati ve humidity range within 30% to 75%
Atmospheric pressure range within 500 to 1060hPa
Operati ng alti tude less than or equal to 12,000 feet above sea level
Environmental
Comply with all local codes when disposing of packaging, equipment or any other portion of this product.
Equipment That May Be Supplied
The console, foot pedal, power cord, cart, nitrogen line, canister, and adapters that may be supplied are non-sterile.

IEC 60601-1-2:2007 Table 1 Requirements

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The equipment 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.n
RF emissions CISPR 11 Class A The equipment is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the equipment or shielding the location.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies

IEC 60601-1-2:2007 Table 2 Requirements:

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
Equipment should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±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 %.
Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines ±1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000- 4-5 ±1 kV line(s) to line(s) ±2 kV line(s) to earth ±1 kV line(s) to line(s) ±2 kV line(s) to earth Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 UT = 230 Vac dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the equipment requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterruptible power supply or a battery.
Power frequency (50 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m hould be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 60601-1-2:2007 Table 4 Requirements:

The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
equipment should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 V Portable and mobile RF communications equipment should
be used no closer to any part of the equipment including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 3 V/m 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 electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of known RF transmitting devices and 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) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV 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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

IEC 60601-1-2:2007 Table 6 Requirements:

Recommended separation distances between portable and mobile RF communications equipment and the Myriad System
The Myriad is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Myriad] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Myriad] 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
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz

0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.69 3.69 7.38
where to find us
Global Surgical Distribution (GSD)
115 The Promenade, Camp Hill, Queensland, Australia, 4152
contact