LED DayLite Operation Manual Jan 2008

Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).

Table of Contents

Indications for Use

…………………………………..…..……………….3

Device Description

………………………………………..….…….……3

Directions for Use

…...………………………………..………….………4

Inspection and Preventative Maintenance

Cautionary Statements

Interference may occur in the vicinity of equipment containing a transmitter.

……….……..………….…8

………………………………….…….…..…….9

Plug and Cord Sets ……………………….……….………..……….….11

Description of Various Symbols

Specifications

Warranty

…….……….………………..………12

…………………………………………………………...13

…………………………………………………………..……..14

Guidance and Manufacturer’s Declaration

……………………..…...15

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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Table 204 – Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT Life-Supporting

Guidance and Manufacturer’s Declaration – Emissions The LED DayLite is intended for use in the electromagnetic environment specified below. The customer or user of the LED DayLite should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance Portable and mobile communications equipment should be separated from the LED DayLite by no less than the distances calculated/listed below:

Conducted RF IEC 61000-46

3 Vrms

3 Vrms

D=(3.5/v1)(Sqrt P)

3 V/m

D=(3.5/E1)(Sqrt P)

IEC 61000-43

The Designs for Vision LED DayLite, Model DVI-LEDST is a headset mounted headlight that is designed for general illumination in surgical settings or wherever bright, portable light is needed.

Device Description The Designs for Vision LED DayLite provides bright, portable light to the surgical environment. It is designed to be comfortable yet functional. It is powered by three lithium ion batteries and has an adjustable intensity switch ranging from 10% to 100% intensity. The LED DayLite generates a 3” spot of light at a 16 inch working distance. The light has a correlated color temperature of 5800˚K at an intensity of up to 13000 footcandles. The unit can run on battery power for approximately 4½ hours before needing to be recharged.

The LED DayLite consists of the following: Two (2) Grey Power Packs Two (2) Leather Holsters Two (2) Ratcheting Belt Clips Desktop Charger Power Link Cable Operation Manual Twin Beam Headset w/ Adjustable Rod Carrying Case

150 kHz to 80 MHz

3 V/m Radiated RF

Indications for Use

80 to 800 MHz

80 MHz to 2.5 GHz D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz

Always examine the unit and accessories for damage before commencing treatment. A damaged unit or damaged accessories must not be used and must be replaced. Use original DVI parts and accessories only.

Where P is the max power in watts and D is the recommended separation distance in meters.

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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30% Dip for Directions for Use 1.

25 Cycles >95% Dip for

Remove the components from the shipping container, checking that all parts on the packing list have been received. Carefully remove the headset, power packs and the charger from their packaging.

>95% Dip for

Power Frequency

3 A/m

3 A/m

50/60 Hz

The desktop charger is designed to meet multinational regulatory requirements and has multiinput voltage capability to accommodate various line voltages from 100-240 VAC. The unit is to be charged only with the supplied charger. 3.

5 Seconds

interruptions, it is recommended that the LED DayLite be powered from an uninterruptible power supply or battery.

5 Seconds

Figure 1 2.

25 Cycles

Magnetic Field

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

IEC 61000-4-8

Plug the cord into the receptacle on the side of the power pack. (Fig. 1) Note: The cord can be inserted into the jack on either side of the power pack.

4.

Plug the other end of the cord into the charger (Fig. 2) and connect the desktop charger to the AC outlet. (Fig. 3) Note: International plugs are available through Designs for Vision; refer to the list of part numbers on page 11.

Figure 2

5.

The LED on the top of the desktop charger should be illuminated red. (Fig. 4) This indicates that the unit is in rapid charge mode. Allow a minimum of three hours for the battery to obtain a full charge. Note: When the LED turns green, the unit is fully charged.

Figure 3

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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Table 202 – Guidance and Manufacturer’s Declaration – Immunity All Equipment and Systems

Guidance and Manufacturer’s Declaration – Immunity The LED DayLite is intended for use in the electromagnetic environment specified below. The customer or user of the LED DayLite should ensure that it is used in such an environment. Figure 4 Immunity Test ESD IEC 61000-4-2

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

±6kV Contact

±6kV Contact

Floor should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%.

±8kV Air

±8kV Air

EFT

±2kV Mains

±2kV Mains

IEC 61000-4-4

±1kV I/Os

±1kV I/Os

Surge

±1kV Differential

±1kV Differential

±2kV Common

±2kV Common

IEC 61000-4-5

With client modifications Voltage Dips/Dropout

>95% Dip for

IEC 61000-411

0.5 Cycle

>95% Dip for 0.5 Cycle

60% Dip for 60% Dip for

5 Cycles

5 Cycles 30% Dip for

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

6.

You can now disconnect the charger to run on battery. The holsters included with your purchase will allow you to carry the unit around with you.

7.

In addition to the holsters, Ratcheting Belt Clips have o been included to allow for a full 360 rotation of the unit, even while it is attached to you. To place the belt clip on to holster, simply slide it up over the raised circular ratchet disk until a ‘click’ is heard (see Fig. 5 below).

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 LED DayLite requires continued operation during power mains

Figure 5

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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8.

Mount the Twin Beam headset by making sure the restraints are open and placing it on your head. Once the headset is in a comfortable position, tighten the restraints around your head and secure it in position. Further adjustments can be made by articulating the headlight up or down.

Table 201 – Guidance and Manufacturer’s Declaration – Emissions

9.

Plug the cord from the headset into the socket on the top of the power pack and screw down until locked. (Region 1 on Fig. 6)

The LED DayLite is intended for use in the electromagnetic environment specified below. The customer or user of the LED DayLite should insure that it is used in such an environment.

10.

To activate the unit, turn the intensity knob clockwise. The intensity can be adjusted from 10-100% power depending on your specific needs. (Region 2 of Fig. 6)

All Equipment and Systems

Guidance and Manufacturer’s Declaration – Emissions

Emissions Test

Compliance

Electromagnetic Environment- Guidance

RF Emissions CISPR 11

Group 1, Class B

The LED DayLite 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.

Harmonics

Class A

The LED DayLite is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

1 2

IEC 61000-3-2 Flicker IEC 61000-3-3

Figure 6

11.

Clips on headset are to be used to direct the cable away from your face.

12.

In the event that you require additional run-time with your LED DayLite, we have supplied a Power Link Cable, which will allow you effectively double the number of hours your headlight will last.

13.

Simply connect two Power Pack units together, as shown in Figure 7, and plug your headlight into either one. Intensity can be controlled by the power pack that your headlight is plugged into.

Complies

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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Warranty The LED DayLite is warranted against imperfections and defects in materials and workmanship for as long as you own the unit. The batteries are warranted for one year. DESIGNS FOR VISION, INC. will make available upon request, circuit diagrams, component part lists, descriptions, and calibration instructions.

Figure 7

CAUTION: If the equipment is used in a manner not specified by Designs for Vision, the protection provided by the equipment may be impaired. MISE EN GARDE: Si l’équipement n’est pas utilisé de la façon spécifiée par Designs for Vision, la protection qu’il fournit pourrait être compromise.

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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Specifications Inspection and Preventative Maintenance 1.

2.

It is recommended that all the exposed plastic sections of the headlight and power pack be wiped with Cavicide surface disinfectant/cleaner. Note: Do not use alcohol, phenol, ammonia or iodine complex solutions. Wipe the sections rather than spray onto plastic parts. Note: Do not let liquids enter openings or ports. Do not immerse parts in solutions. Using solutions other than recommended may void warranty. Allowing liquids to enter openings or ports may void warranty.

POWER REQUIREMENTS Designs for Vision LED DayLite Model Number: DVI-LEDST

For Charging : 100V - 240V, 50/60 Hz Charger Model : Cell-Con P/N 452240-LC ILLUMINATION At 16” measured with a cosine corrected light meter 0 –13,000 foot-candles ± 5% (0 –139,880 lux ± 5%)

Twin Beam Headset 3.

Clean headlight lenses with glass cleaner, making sure not to scratch the surface.

Battery Power : 11.1 V, 2600mAh 3-Cell 18650 Li-Ion Battery Pack

OVERCURRENT PROTECTION ENVIRONMENTAL OPERATING CONDITIONS: TEMPERATURE: RELATIVE HUMIDITY: ATMOSPHERIC PRESSURE: STORAGE & SHIPPING TEMPERATURE: RELATIVE HUMIDITY: DIMENSIONS: POWER PACK: HEADLIGHT: WEIGHT: APPROVALS:

Resetable Polyfuse

O

O

O

O

10 C to 40 C 30% to 75% 700 to 1060 hPa -20 C to 40 C 10% to 90% 4.94” x 2.75” x 0.94” 11.00” x 7.50” x 6.00” 15.17 oz UL 60601-1: 2001 CAN/CSA 60601-1: 2001

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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Description of Various Symbols

Cautionary Statements

ATTENTION: CONSULT ACCOMPANYING DOCUMENTS

NOTE: Disposal of the equipment and the accessories at the end of their useful lives should be in accordance with all national and local regulations.

INDICATES CONFORMITY OF THE PRODUCT WITH MDD 93/42/EEC ANNEX VII

REMARQUE: À la fin de leur vie utile, l’appareil et ses accessoires doivent être mis au rebut conformément à toutes les réglementations nationales et locales.

ON / OFF / INTENSITY CONTROL

NOTE: For a complete charge, make sure to turn the intensity knob to the left until the knob clicks into the off position. REMARQUE: Pour obtenir une charge complète, tourner le bouton d’intensité vers la gauche jusqu’à qu’il parvienne à la position « off » et qu’un déclic se fasse entendre.

HEADLIGHT SOCKET

NOTE: When not in use, make sure to click the intensity knob into the off position. REMARQUE: Si non utilisable, veillez à cliquer le bouton d'intensité dans la position de repos. CAUTION: In the unlikely event that this equipment causes electromagnetic interference such as dots or lines on a computer monitor, please inform Designs for Vision, Inc., so that the cause of the interference can be properly investigated. MISE EN GARDE: Dans l’éventualité peu probable où cet appareil causerait une interférence électromagnétique, telle que l’apparition de points ou de lignes sur un écran d’ordinateur, veuillez en informer Designs for Vision, Inc. afin que la cause de cette interférence soit étudiée dans les plus brefs délais. CAUTION: Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents.

Designs for Vision, Inc.

Designs for Vision, Inc.

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

760 Koehler Avenue • Ronkonkoma, NY 11779 • 631/585-3300 Toll Free 800/345-4009 • Fax 631/585-3404 • Web Site www.designsforvision.com

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