PARI LC SPRINT NEBULIZER Instructions for use

INDICATIONS FOR USE: LC® SPRINT The LC® Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC® Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

A. SAFETY PRECAUTIONS - LC® SPRINT Welcome to the Vios experience! The Vios® Aerosol Delivery System is designed from PARI’s long legacy of clinically proven products and consists of two important components: a Vios® compressor and a PARI nebulizer.Vios® was inspired by the Latin and Greek words for “Life” and our goal is to improve your quality of “Life” through the efficient delivery of aerosol. Your physician has prescribed the Vios® to treat your respiratory symptoms because of PARI’s reputation for consistent particle size and fast treatments resulting in targeted delivery to the lungs. PARI products have been used in more than 25 clinical trials for new nebulized medications. Designed with the patient in mind, these instructions will help you achieve the best aerosol therapy experience. We hope the Vios experience allows for a “Life Inspired”.

SAVE THESE INSTRUCTIONS FOR FUTURE USE

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CAUTION US Federal Law restricts this device to sale by or on the order of a physician. Use only when prescribed by a physician and with the prescribed medication. The LC® Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC® Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication. Improper use can result in serious or fatal illness or injury. Nebulizer is not sterile.

WARNING Use only when prescribed by a physician and with the prescribed medication. In order to achieve the specified droplet characteristics the compressor or central air supply must provide 3.5 - 8 lpm at a minimum of 20psi.

WARNING 1. To reduce the risk of increased bacterial growth, infection, illness, or injury from contamination: thoroughly clean and dry all parts of the nebulizer and thoroughly dry any moisture or condensation in the tubing at the end of every treatment following the enclosed instructions. 2. Cleaning the nebulizer after each treatment is not enough---you must regularly disinfect or sterilize the nebulizer between treatments to prevent serious or fatal illness caused by contamination of the nebulizer. 3. Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, the aerosol mist will be reduced, altered or stopped, which will diminish or eliminate the effectiveness of the treatment. If clogging occurs, replace with the same model PARI Reusable Nebulizer. 4. Close supervision is necessary when this product is used by or near children and physically or mentally impaired. Never use when sleeping or drowsy. 5. This product contains small parts that may present a choking hazard to small children. The tubing also presents a strangulation hazard. ALWAYS USE CLOSE ADULT SUPERVISION WHEN ADMINISTERING A TREATMENT TO A CHILD. DO NOT LEAVE CHILD UNATTENDED DURING TREATMENT. 6. Patients under the age of 4 or any patients who have special needs should use a facemask instead of the valved mouthpiece. 7. Before use, check PARI Reusable Nebulizer for proper assembly. All parts should be seated firmly in place. Use of an improperly assembled nebulizer could diminish or prevent ad equate delivery of medication and the effectiveness of the treatment.

INDICATIONS FOR USE: VIOS® AEROSOL DELIVERY SYSTEM The Vios® is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Vios® Compressor is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

B. SAFETY PRECAUTIONS - VIOS® AEROSOL DELIVERY SYSTEM WARNING

WARNING

Use only with nebulizers and tubing authorized by PARI for this device. Other nebulizers and tubing may result in improper treatment. When using electrical and medical products, especially when children are present, basic safety precautions must be followed.

6. Do not operate outdoors. 7. Not suitable for use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide. 8. Do not operate where oxygen is being administered in a closed environment such as an oxygen tent. 9. Never drop or insert any object into any openings. 10. Always unplug this product immediately after using. 11. Be sure the PARI Vios® Compressor is unplugged prior to cleaning. 12. Do not open or disassemble the PARI Vios® Compressor. Refer all servicing to PARI.

DANGER To reduce the risk of serious or fatal injury from electrocution: 1. Do not place or store product where it can fall or be pulled into a bathtub, sink, water, or other liquid. Do not place in or drop into water or other liquid. Do not use while bathing. 2. Do not reach for a product that has fallen into water or other liquid. Unplug immediately.

WARNING To reduce risk that the compressor will fail to operate properly as a result of decreased electromagnetic interference, resulting in improper treatment:

WARNING To reduce the risk of serious or fatal injury from electrocution, fire or burns and to reduce the risk of damage and malfunction to the product: 1. Before use, check the serial number label on the bottom of the PARI Vios® Compressor to ensure that the voltage and current indicated on the compressor label correspond to the voltage and current available. 2. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or if it has been exposed to any liquids inside the case. Please contact PARI Patient Connection at 1.800.FAST.NEB (327.8632). 3. Keep all electrical cords away from heated surfaces. Do not overload wall outlets or use extension cords. 4. This appliance has a polarized plug (one blade is wider than the other). As a safety feature, this plug will fit in a polarized outlet only one way. If the plug does not fit fully in the outlet, reverse the plug. 5. Never block the air vents of this compressor or place it on a soft surface, such as a bed or couch, where the air vents may be blocked. Keep the air vents free of lint, hair, and similar substances. Blocked vents could cause excessive heat buildup. This product should never be left unattended when plugged in.

1. This device needs special precautions regarding electromagnetic compatibility (“EMC”) and must be installed and put into service according to the EMC information provided in these Instructions For Use. 2. Portable and mobile radio frequency (“RF”) communication devices can disrupt electrical medical equipment. Technical EMC information is available on pages 9-10. 3. Use only with accessories and cables authorized by PARI for this device. Use of this device with unauthorized accessories and cables may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device. 4. This device should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, this device should be observed to verify normal operation.

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C. GETTING STARTED Check your Vios® package to ensure you have the following items. It is important to have a second PARI Reusable Nebulizer on hand at all times.

Air Filter Air Outlet Power Switch

Air Vents PARI Reusable Nebulizer Holder & Clip Nebulizer Replacement Sticker Sheet

Inspiratory Valve Cap

PARI LC® Sprint Reusable Nebulizer (2 included)

Nebulizer Top

Nebulizer Outlet Mouthpiece with Expiratory Valve

Nebulizer Insert

Nebulizer Cup Nebulizer Replacement Sticker Suggested Placement Air Intake Bubbles the Fish™ II Pediatric Aerosol Mask (Included in pediatric configurations only)

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Wing Tip® Tubing

D. VIOS® SET-UP You are 10 Steps away from starting your treatment with Vios®. Please follow step by step. 1.

Clean/Disinfect Nebulizer Cup: Refer to Section E & F to properly clean and disinfect your nebulizer prior to first use. Re-assemble nebulizer.

WARNING Never block the air vents of this compressor or place it on a soft surface, such as a bed or couch, where the air vents may be blocked. Keep the air vents free of lint, hair, and similar substances. Blocked vents could cause excessive heat buildup. 2.

3.

4.

5.

Set-up Compressor: Place the compressor on a flat, stable surface free of dust. Avoid cushioned, upholstered or carpeted surfaces. Make sure power switch is turned to , the “OFF” position. Plug power cord into wall outlet (Fig A). Connect Tubing To Compressor: Insert one end of Wing Tip® tubing to the air outlet on the compressor. It should fit snugly (Fig. B). Load Medication: Open the inspiratory valve cap of nebulizer by lifting the cap (Fig. C). Pour the prescribed dose of medication into the nebulizer cup. Never fill past the max. fill line of 8 ml. Attach Mouthpiece or Mask: If using the mouthpiece, attach the mouthpiece to the nebulizer outlet with the expiratory valve facing up. Then close the inspiratory valve cap by pressing firmly on the nebulizer top. If using the Bubbles the Fish™ II Pediatric Mask provided with the unit, attach the

mask directly to the nebulizer outlet. If using another type of mask refer to the mask instructions. 6. Attach Tubing To Nebulizer Cup: Firmly press the other end of the Wing Tip® tubing to bottom of PARI reusable nebulizer (Fig. D). 7. Starting Treatment: Sit in a relaxed, upright position and turn the compressor “ON” . 8. Nebulizer Position: Place the mouthpiece on top of tongue and close lips around it. Take slow, deep breaths. As you inhale, the inhalation valve opens. 9. Breathing: For mouthpiece, inhale and exhale slowly through your mouth. As you exhale, the valve on the mouthpiece opens to allow the exhaled mist to escape. For mask, place mask over nose and mouth and inhale and exhale slowly. 10. Complete Treatment: Continue until the medication is gone or you hear a slight “sputtering” sound. Turn compressor “OFF” .

A NOTE ON TREATMENT TIME Please note that many factors affect treatment time, such as a patient’s age, condition, breathing pattern, and medication. The Vios® was designed for intermittent use to deliver respiratory medications, not continuous use for humidification or prolonged treatments (for example, over 35 minutes at one time). It is possible with prolonged treatments that the tubing may get warm and disconnect from the Vios® air outlet. If your physician prescribed consecutive (back to back) treatments, resulting in the use of your Vios® for longer than 35 minutes at a time, please contact PARI Patient Connection at 1.800.FAST.NEB (327.8632).

A

B

C

D

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E. CLEANING YOUR PARI REUSABLE NEBULIZER 1. 2.

3. 4. 5. 6. 7.

Disconnect the tubing from the air intake on the bottom of the nebulizer cup. If there is any moisture (condensation) in the tubing, let the compressor run with only the tubing attached for 2-3 minutes. The warm air from the compressor will dry out the tubing. Alternatively, you can dry the tubing by removing it from the compressor and hanging it up with the “ends down” to allow any moisture (condensation) to drain out and evaporate. Use a clean damp cloth to wipe the exterior of the tubing. Disassemble reusable nebulizer parts as illustrated on page 3. Wash all parts including the Bubbles II pediatric mask with warm water and liquid dish soap. DO NOT WASH THE TUBING. Rinse the reusable nebulizer parts and Bubbles II pediatric mask thoroughly with warm water and shake out water. Air dry or hand dry nebulizer parts on a clean, lintfree cloth. Reassemble nebulizer when parts are dry and store. You can also wash all parts of the reusable nebulizer on the top shelf of a dishwasher. DO NOT PLACE BUBBLES II MASK IN DISHWASHER. DO NOT WASH TUBING. Place the reusable nebulizer parts in a dishwasher basket, then place the basket on the top rack of the dishwasher. Remove and dry the parts when the dishwasher cycle is complete.

WARNING TO REDUCE RISK OF INFECTION: 1. Nebulizer for single patient use (one person) only. Do not share your nebulizer with other patients. 2. You must regularly disinfect or sterilize the nebulizer between treatments. Failure to do so could lead to serious or fatal illness.

F. DISINFECTING YOUR PARI REUSABLE NEBULIZER 1.

2.

3.

4.

5.

Clean the nebulizer as described in Section E. For low-level disinfection every other treatment day, soak all parts of the PARI Reusable Nebulizer (except tubing and mask) in a solution of 1 part distilled white vinegar and 3 parts hot tap water for 1 hour. You can substitute respiratory equipment disinfectant (like Control III®) for distilled white vinegar (follow manufacturer’s instructions for mixing). Rinse all parts of the PARI Reusable Nebulizer thoroughly with warm tap water and dry with a clean, lint-free cloth. Discard the vinegar solution when disinfection is complete. The PARI Reusable Nebulizer parts (except tubing and mask) may also be disinfected by boiling them in a clean pot of water for a full 5 minutes. Hospitals and clinics can sterilize the PARI Reusable Nebulizer parts (except mask and tubing) by autoclaving (a maximum of 277° F or 136° C), follow autoclave manufacturer’s instructions. Dry parts on a clean, lint-free cloth.

CONTROL III® is a registered trademark of Maril Products, Inc. NOTE: FOR PATIENTS WITH CYSTIC FIBROSIS, THE CF FOUNDATION RECOMMENDS BOILING FOR A FULL 5 MINUTES TO DISINFECT.

E

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G. MAINTENANCE OF YOUR VIOS® NEBULIZER SYSTEM

COMPRESSOR Use a damp cloth to wipe the exterior of your Vios® housing and Wing Tip® tubing.

FILTER

CAUTION

Your Vios® air filter is bright white when new. With use, the filter will slowly turn grey, indicating the need for replacement. The filter must be replaced immediately if it gets wet or becomes clogged. A good rule to follow is to replace your filter every 6 months – at the same time as your PARI reusable nebulizer .

Never spray fluid into the ventilation slots on your Vios®. Fluid could cause damage to the electrical & compressor parts and could lead to malfunction. In the event fluid enters the unit, please contact PARI Patient Connection at 1.800.FAST.NEB (327.8632).

Removing: First make sure the Vios® power switch is turned off. Using a coin, remove the air filter cover by turning it counter-clockwise (Fig.E). Pull the cap and filter out, then remove the filter from the cap (Fig.F-G).

MAINTENANCE & REPAIR Never operate your Vios® if it is improperly or incompletely assembled or damaged. Use only original PARI parts and attachments authorized by PARI for the Vios® Aerosol Delivery System. Use of other parts and attachments may damage the unit or cause improper treatment. Do not open or disassemble the compressor unit at any time.

NOTE: THERE ARE TWO TYPES OF FILTERS THAT FIT THE VIOS® COMPRESSOR. IF YOUR FILTER IS OPEN ONLY ON ONE END AS SHOWN IN FIGURE F, FOLLOW INSTRUCTIONS AS SHOWN IN FIGURE F AND G. IF YOUR FILTER IS OPEN ON BOTH ENDS, PRESS EITHER END OF THE FILTER INTO THE CAP.

NOTE: THERE ARE NO SERVICEABLE PARTS INSIDE THE VIOS® AEROSOL DELIVERY SYSTEM. SERVICE BY ANYONE VOIDS WARRANTY.

Take a new filter and press into cap with the open end visible. Place the cap and filter back into the front of your Vios®. Use the coin to tighten by turning the cover clockwise.

REMEMBER

REPLACE YOUR REUSABLE NEBULIZER CUP EVERY SIX MONTHS

NOTE: DO NOT ATTEMPT TO WASH AND REUSE AIR FILTERS. DO NOT USE SUBSTITUTE FILTER MATERIAL COMPRESSOR DAMAGE MAY RESULT.

It is very important to replace your PARI reusable nebulizer every 6 months for the most effective treatments. Advantages of Replacing Your Nebulizer Cup: -Consistent medication delivery to the lungs -Fast and efficient treatments -Bacterial contamination can be reduced* Included in this configuration is a reminder sticker. Place the sticker that corresponds to six months from date of first use to the smooth surface on the bottom of your nebulizer cup as indicated in this picture. Sticker is dishwasher safe.

Nebulizer Replacement Sticker Suggested Placement

Allow two hours after label is applied before cleaning. WARNING: The sticker may present a choking hazard to small children-adult supervision is required. * L ester, Mary K. Nebulizer Use and Maintenance by Cystic Fibrosis Patients: A Survey Study. Respiratory Care 2004; 49(12): 1504-1508.

F

G

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H. SPECIFICATIONS VIOS® SPECIFICATIONS Weight...3 lbs. Dimensions:... 6.5 x 6.5 x 3.75 in. Electrical Requirements:... 120V AC, 60Hz, 1.5A Power Wattage:... 80 W, under normal load Ambient Operating Conditions:... 10°C to 40°C, (50°F to 104°F) Power cord length:... 5 ft.

TRANSPORT/STORAGE CONDITIONS: Ambient temperature:...-40°C to 70°C, (-40°F to 158°F) Relative Humidity:... 10% to 95% Atmospheric Pressure:...500 hpa to 1060 hpa

AEROSOL PERFORMANCE PARI Vios compressor with PARI LC® Sprint nebulizer1 ®

Albuterol Sulfate

Ipratropium Bromide

MMAD (µm) 2

1.63

2.03

Cromolyn Sodium 1.63

RM (% of fill) 3

21.30

22.07

16.20

Total Dose (µg) 4

697.4

142.0

4394.6

EXPLANATION OF SYMBOLS Attention: Read all “Instructions for Use” before operation:... Insulation enclosed Class II equipment:... Type “B” Protection from electrical shock:... Do not dispose of in unsorted municipal trash. Please consult local laws and regulations for proper disposal:... Power Switch:... “On” Position (compressor running):... “Off” Position (compressor is not running):...

NOTE: WHEN SWITCH IS IN THE “OFF” POSITION AND THE COMPRESSOR IS NOT RUNNING, THERE WILL STILL BE ELECTRICAL POTENTIAL INSIDE THE COMPRESSOR HOUSING. TO REMOVE POWER FROM THE COMPRESSOR, THE POWER PLUG MUST BE REMOVED FROM THE POWER SOURCE.

(1) Measured by 7-stage Cascade Impactor, with membrane filter for 8th stage, equipped with a USP <601> throat, at 28 LPM continuous inspiratory flow. (2) Mass Median Aerodynamic Diameter (3) Respirable Mass delivered (0.5 – 5 µm) as a percentage of initial fill (4) Total Dose delivered by the nebulizer and captured by the impactor

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I. WARRANTY & RETURN INFORMATION PARI LC ® SPRINT REUSABLE NEBULIZER LIMITED WARRANTY PARI reusable nebulizers include a 6 month limited warranty for home care use. If you have any problems and need to return your PARI reusable nebulizer, contact PARI Patient Connection at 1.800.FAST.NEB (327.8632). Please be sure to clean and disinfect your PARI reusable nebulizer and place it in a plastic bag before returning.

VIOS® AEROSOL DELIVERY SYSTEM LIMITED WARRANTY PARI offers a standard five (5) year limited warranty on the Vios® Aerosol Delivery System and its parts. The warranty period will be printed on the serial number label located on the bottom of the compressor. PARI warrants that the Vios® Aerosol Delivery System and its parts will be free from defects in workmanship and materials for a period of sixty (60) months, from the date of first retail purchase of the equipment. This warranty does not cover failures of the nebulizer, tubing, or accessories. This warranty does not extend to failures resulting from accident, misuse, abuse, alteration, use of unauthorized service; parts or cleaning solutions, or failure to comply with Instructions For Use. If the warranted equipment should fail during the warranty period, PARI, at its option, will repair or replace the equipment or parts at issue, provided the claim is bona fide. It shall be the responsibility of the purchaser to pack and return the equipment in a manner to avoid shipping damage. The shipment must be prepaid to PARI Respiratory Equipment, Inc. This warranty covers the cost of labor incurred in the removal or replacement of the warranted component parts at authorized PARI service centers only. To make a claim under this warranty, notify the authorized service center by calling PARI Patient Connection at: 1.800.FAST.NEB (327.8632), Press 2 THERE ARE NO OTHER EXPRESS WARRANTIES.ALL IMPLIED WARRANTIES ON THE Vios® Aerosol Delivery System AND ITS PARTS, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED TO SIXTY (60) MONTHS FROM THE DATE OF FIRST RETAIL PURCHASE. ALL EXPRESS OR IMPLIED WARRANTIES ON ANY OTHER PARTS, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE DISCLAIMED. Some states do not allow limitations on how long an implied warra nty lasts, so the above limitation may not apply you. The sole and exclusive remedy under this warranty is to repair or replace the Vios® Aerosol Delivery System and/or its parts at the option of PARI. IN NO EVENT SHALL PARI BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES TO THE PURCHASER OR ANY THIRD PARTY, INCLUDING WITHOUT LIMITATION, DAMAGES ARISING FROM LOST PROFITS, LOSS OF BUSINESS OPPORTUNITY, LOSS OF PROPERTY, ECONOMIC LOSSES, OR STATUTORY OR EXEMPLARY DAMAGES, WHETHER IN NEGLIGENCE, WARRANTY, STRICT LIABILITY OR OTHERWISE. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to you. This warranty gives you specific rights.You may also have other rights which vary from State to State.

Register your Vios® Aerosol Delivery System today with one of these three ways. Online at pari.com/register Call 1.800.FAST.NEB (327.8632) Fill out the pre-addressed, postage paid registration card and drop it in any USPS Mailbox. Failure to register your Vios® does not affect your standard product limited warranty. If you have any problems and need to return your Vios® compressor, contact PARI Patient Connection at 1.800.FAST.NEB (327.8632).

Manufactured for:

PARI Respiratory Equipment, Inc. 2412 PARI Way, Midlothian, VA 23112 USA Tel: 800.FAST.NEB (327.8632) and 804.253.7274 Fax: 800.727.4112 | [email protected] Online at: www.PARI.com

© 2018 PARI Respiratory Equipment, Inc. 310D0122 Rev B 04-18

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J. SPECIFICATIONS: IEC TABLES The Following Tables Are Provided In Accordance With IEC 60601-1-2: Recommended separation distances between portable and mobile RF communications equipment and the Vios® The Vios® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Vios® can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Vios® can help prevent electromagnetic interference by maintaining a minimum 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

d=

3,5 V1

80 MHz to 800 MHz

P

d=

.12 .37 1.17 3.69 11.67

0,01 0,1 1 10 100

3,5 E1

P

.12 .37 1.17 3.69 11.67

800 MHz to 2,5 GHz

d=

7 E1

P

.23 .74 2.33 7.38 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection f rom structures, objects and people.

Guidance and manufacturer’s declaration – electromagnetic immunity The Vios® is intended for use in the electromagnetic environment specified below. The customer or the user of the Vios® should assure that it is used in such an environment. Immunity test

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

IEC 60601 test level

Compliance level

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

±2 kV for power supply lines

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV for input/output lines

±1 kV differential mode

±1 kV differential mode

±2 kV common mode

±2 kV common mode

<5 % UT (>95 % dip in UT) for 0,5 cycle

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95 % dip in UT) for 5 sec

Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

3A/m

3A/m

IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level.

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Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Vios® requires continued operation during power mains interruptions, it is recommended that the Vios® be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration –electromagnetic emissions The Vios is intended for use in the electromagnetic environment specified below. The customer or the user of the Vios® should assure that it is used in such an environment. ®

Emissions test

Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

Not applicable

Electromagnetic environment – guidance The Vios® 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. The Vios® 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.

Guidance and manufacturer’s declaration –electromagnetic immunity The Vios® is intended for use in the electromagnetic environment specified below. The customer or the user of the Vios® should

assure that it is used in such an environment. Immunity test

IEC 60601 test level

Electromagnetic environment – guidance

Compliance level

Portable and mobile RF communications equipment should be used no closer to any part of the Vios®, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms 150 kHz to 80 MHz

d=

3,5 V1

P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m 80 MHz to 2,5 GHz

d=

3,5 E1

P 80 MHz to 800 MHz

d=

7 E1

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 metres (m). Field strengths from fixed RF transmitters, as detera mined by an electromagnetic site survey, should be less b than the compliance level in each frequency range. 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) 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 Vios® is used exceeds the applicable RF compliance level above, the Vios® should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Vios®.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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