Ambrose LED Headlight Operating Manual Rev 4 May 2015

Table of Contents SYMBOL DESCRIPTIONS...2 WARNINGS AND PRECAUTIONS...3 INTENDED USE...3 UNINTENDED USES...3 OVERVIEW...4 ASSEMBLY AND OPERATION...5 HEADLIGHT ASSEMBLY...5 CONTROLLER...7 USING THE AC POWER SUPPLY (ACCESSORY)...7 BATTERY CHARGING...9 CLEANING AND MAINTENANCE...11 HEADLIGHT...11 SPECIFICATIONS...12 CLASSIFICATION...12 DIMENSIONS...12 PERFORMANCE...12 ELECTROMAGNETIC CAPABILITY...13 TROUBLESHOOTING...15 WARRANTY AND SERVICE...15

Symbol Descriptions These important symbols may appear on your Long Island Technology Group Optic Headlight. Please note their meaning. Attention: Read this owner’s manual for all warnings, precautions, and instructions for use.

Type B Equipment.

The CE mark indicates this product has been tested to, and conforms to applicable standards.

The UL mark indicates this product has been tested to, and conforms to applicable standards.

More information for this product can be found in this operating manual.

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Warnings and Precautions Users of this product should be thoroughly trained in the appropriate medical procedures. Also they should read and understand this owner’s manuals for this headlight and all equipment used with it.

Do not shine light into eyes. Eye injury may result.

Use Headlight only with Long Island Technology Group accessories, power supplies, batteries, and controllers. Do not modify this equipment.

Service must be performed only by Long Island Technology Group or properly trained biomedical technicians.

Avoid prolonged contact with the headlight during use as it may be hot.

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put in service according to the EMC information in the Electromagnetic Capability section of this manual.

Intended Use

The Ambrose™ is an ultra-portable medical light source. The device is intended to be mounted on a headband or to the glasses frame of the doctor’s loupes or eyewear. An Iris system permits the light spot size to be adjusted to three fixed diameters. The light is an excellent supplementary light source for examinations and procedures. The advantage of the Ambrose™ system is that the light is positioned between the doctor’s eyes, making the direction of illumination always in the exact direction of the doctor’s vision.

Unintended Uses

This product is not intended for ophthalmic procedures or for transillumination.

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Overview D

B

E

A

C

A. Headlight B. Iris C. Glasses clip (accessory) D. Battery w/ Holster E. Controller F. Battery Charger G. Charger Power Supply

G

F

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Assembly and Operation Headlight Assembly

1. Attach optic (1) to glasses though use of glasses clip (2) if using glasses.

DIAGRAM 1. 2

1

2. Attach power cable to glasses using the cable wrap (3) by wrapping it around both the wire and glasses frame as shown in Diagrams 2a-c. 1. Optic

(P002302)

2. Glasses Clip 3.

(accessory) (P002327) Cable Wrap (P002331)

DIAGRAM 2a.

3

5

DIAGRAM 2b.

DIAGRAM 2c.

3. Place the battery (4) in the holster (5). 4. Attach the battery power cable from the battery holster (5) to the controller connector (6). Twist the connector cap until cable is locked in place. 5. Cable requires provided ferrite near the controller for EMC compliance.

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DIAGRAM 3. 5 4

4. Battery (P002361) 5. Battery Holster (P002362) 6. Controller Power Connector

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Only use Long Island Technology Group batteries. Replacement of batteries by untrained personnel could result in dangerous conditions such as fire or explosion.

Using the AC Power Supply (Accessory) (P002364)

1. Unplug battery holster cable if still plugged in. 2. Plug power supply output power cable into the controller connector. Twist the connector cap until cable is locked in place.

DIAGRAM 4.

WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

Controller

1. Attach the controller to the back of garments, pocket, or waistband with the controller clip (13). 2. Push the “Power” button (7) to turn light on. 3. Push the “Up” button (9) to make the light brighter. 4. Push the “Down” button (8) to make the light dimmer. 5. Push the “Turbo” button (10) to put the device in turbo mode. 6. The light level is shown by the four circular Light Level Indicator LEDs (11). 7

7. Pushing “UP” button (9) or “Down” button (8) will cycle though the four circular Light Level Indicators (11) equal to the light intensity (low, low-medium, medium-high, high). 8. The top LED circle (12) will denote Turbo mode which is the brightest light intensity. 9. Push the “Power” button (7) while the Ambrose™ is on to turn it off.

DIAGRAM 5. 9

10

7

8

7. Power Button 8. Light Down Button 9. Light Up Button 10. Turbo Button 11. Light Level Indicator LEDs

12. Turbo Indicator 13. Controller Clip (P002357)

14. Adjustable Iris

13

12

11

10. Use the adjustable iris (14) to adjust the spot size from wide to narrow. 11. When the battery is getting low on power the controller will beep, indicating the battery will power off imminently.

DIAGRAM 6. 14

Extended use on Turbo may reduce battery life.

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Battery Charging 1. Remove battery by simultaneously pushing the Retaining Tab (15) and gently pulling the Battery Label Tag (16).

DIAGRAM 7.

16

15

15. Retaining Tab 16. Battery Label Tag 2. Plug the AC Cable (19) in to the power supply. 3. Plug the AC Cable (19) into the Battery Charger (17). 4. The green battery charge indicator light (18) will flash while the battery is charging. When the green light is solid, the battery is fully charged. A red light indicates an error.

DIAGRAM 8. 19

17

18

17. Battery Charger (P002130) 18. Battery Charging Indicator 19. Charger AC Cable 20. Battery Charge Indicator

5. Fully charging the Battery before use will ensure the longest Battery life. 6. Five black bars on the battery charge indicator (20) represent a full charge. 9

DIAGRAM 9.

20

7. When fully charged, remove battery from charger (17). WARNING: To avoid electric shock, DO NOT touch the charger fins

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Cleaning and Maintenance Headlight

1. Clean the Ambrose™ components with an alcohol wipe. 2. Only use a lens cloth or lens paper on the surface of the optic lens. 3. Use a can of compressed air to clean out the air vents if dust builds up.

Do not pour cleaning solution directly on the surface of the Ambrose™.

Do not use any sterilization process or cleaning process using excessive heat or humidity as it will damage the device.

Never immerse the optic or battery in any type of liquid. **Damaging any part of the system with the use of an improper cleaning agent or cleaning process will void all warranties.

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Specifications ELECTRICAL RATING Device Max Electrical Rating

14.4 V, 1.5 A

LED Input Voltage Input Power

3-3.5 VDC 3 Watts Max

CONTROLLER Input Voltage Output Power BATTERY (Lithium-ion) Output Voltage Capacity CHARGER Charger Input Voltage Charger Output Voltage

14.4 VDC 3 Watts 14.4 VDC 3.1 Ah 110/240 VAC 50 -60Hz 24 VDC2.5 A

CLASSIFICATION Classification & Type

Class I Medical Device, General Medical Equipment as to electrical shock, fire, and mechanical hazards only

DIMENSIONS HEADLIGHT LxWxH Weight CONTROLLER LxWxH Weight BATTERY W/ HOLSTER LxWxH Weight

ENVIRONMENT Operation Storage Relative Humidity Pressure/Altitude

PERFORMANCE

Battery life by brightness setting

Field size/Color Temperature

Conforms to: IEC 60601-1 Edition 3 IEC 60601-1-2 Edition 3 AAMI ES60601-1 Edition 1 CSA C22.2 NO 60601-1:08 Edition 2

2.25”x.875”x1” 36 g 4.5”x1.5’x.75’ 64 g 4.75”x3.25”x1.75” 348 g 60°F (15°C) to 80°F (26.7°C) 32°F (0°C) to 104°F (40°C) 45-75% 860 -1,060 hPa/2,000 m >32 hours at 12,500 lux (Level 1) >26 hours at 15,500 lux (Level 2) >22 hours at 18,000 lux (Level 3) >19 hours at 20,500 lux (Level 4) >14 hours at 25,000 lux (Turbo) 1”-3” diameter at 16”, ~6500 K CCT

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!! !Conforms to:

IEC 60601-1 Edition 3 IEC 60601-1-2 Edition 3 AAMI ES60601-1 Edition 1 CSA C22.2 NO 60601-1:08 Edition 2

Electromagnetic Capability Portable and mobile RF communications equipment can affect medical

ELECTROMAGNETIC electrical equipment. CAPABILITY

Portable and mobile RF communications equipment can affect medical electrical equipment Guidance and manufacturer’s declaration – electromagnetic emissions The Ambrose™ is intended for use in the electromagnetic environment specified below. The customer or the user of the Ambrose™ should assure that it is used in such an environment. Electromagnetic Emissions test Compliance environment– guidance The Ambrose™ uses RF energy only for its internal function. Therefore, its RF RF emissions Group 1 emissions are very low and CISPR 11 are not likely to cause any interference in nearby ! electrical equipment. RF emissions TheAmbrose™is suitable for Class A CISPR 11 use in all establishments other than domestic and those Harmonic emissions Not applicable directly connected to the IEC 61000 -3-2 public low-voltage power Voltage fluctuations/flicker supply network that supplies emissions Not applicable buildings used for domestic IEC 61000-3-3 purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity The Ambrose™ is intended for use in the electromagnetic environment specified below. The customer or user of the Ambrose™ should assure that it is used in such an environment. Immunity IEC 60601 Test Compliance Electromagnetic Environment Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Ambrose™ , including cables, than the recommended separation distance calculated from the equation application to the frequency of the transmitter. Recommended Separation Distance : ! Conducted

Battery Operated Device

;L !

3Vrms RF IEC 150kHz – 80 61000-4-6 MHz

3 Vrms

Radiated 3V/meter 80 MHz– 2.5 RF IEC 61000-4-3 GHz

3 V/m from d =1.17 P 80 MHz to 800 MHz 30MHz to 1 GHz, 3V/m for d = 2.33 P 800 MHz to 2.5 GHz 1GHz to 2.5 GHz; (1000 Hz Where P is the maximum output power 80% Modulated rating of the transmitter in watts (W) Test Signal) 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 survey (1), should be less than the compliance level in each frequency range (2). Interference may occur in the vicinity of equipment marked with the following symbol :

d =1.17 P

13 NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

electromagnetic site survey (1), should be less than the compliance level in each frequency range (2). Interference may occur in the vicinity of equipment marked with the following symbol : !

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects, and people. ;N ! ! (1) 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 is used exceeds the Ambrose™ applicable RF compliance level above, the Ambrose™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ambrose™ . (2) Over the frequency rang 150kHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Ambrose™ The Ambrose™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Ambrose™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ambrose™ as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output power of in meters transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.17 P d = 1.17 P d = 2.33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.737 1 1.17 1.17 2.33 10 3.70 3.70 7.37 100 11.70 11.70 23.30 For transmitters rated at a maximum output power not listed above, the recommended separate distance d in meters (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: The I SM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13. 553 MHz to 13. 567 MHz; 2 6.957 MHz to 27. 283 MHz; and 40.66 MHz to 40.70 MHz. NOTE 3: An additional factor of 10/3 has been incorporated into the formulae used in calculated the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. NOTE 4 : These guideline may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects, and people.

!

;O!

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Troubleshooting Sympt om No Light Output

Inability to Change Light Power Low Light Output

Possible Issue Solution Light Source is not connected Plug in light source cord to power source or battery or connect battery Battery is out of charge Recharge the battery Power supply or battery not Return power supply or functioning battery to manufacturer for repair Controller is broken Return light source to manufacturer for repair LED is nearing end of life

Return light source to manufacturer for lamp replacement Light source power is set to Increase power via the low controller Lens is dirty Clean the lens using the instructions provided in this operating manual

Warranty and Service Warranty against manufacturer’s defects applies to the following components of the Ambrose™ under normal use for one (1) year from the date of sale from Long Island Technology Group (includes parts and labor). • • •

LED Optics and Controller Cables and Connectors Battery and Charger

The warranty does not cover products damaged by the following: • Accident, misuse, abuse or alteration • Servicing by unauthorized persons • Use with unauthorized accessories • Connecting to incorrect current and voltage !

;U !

In all cases Long Island Technology Group, reserves the right to determine the cause of all malfunctions and at its sole discretion will determine damage and/or repairs are covered under this warranty. Send All Inquiries To: Long Island Technology Group 60 Carolyn Blvd Farmingdale, New York 11735 USA www.litgp.com [email protected] Tel: (631)-270-4463 Fax: (631)-414-7078

Obelis s.a. Blvd Général Wahis 53 1030 Brussels, Belgium Tel: +(32) 2.732.59.54 Fax: +(32)2.732.60.03 Email: [email protected] 15

Contents are fragile. Contains Li-ion batteries, Handle with care.

E464967

Conforms to: IEC 60601-1 Edition 3, IEC 60601-1-2 Edition 3, AAMI ES60601-1 Edition 1, CSA C22.2 NO 60601-1:08 Edition 2

60 Carolyn Blvd, Farmingdale NY 11735 (631) 270-4463 litgp.com 5HYLVLRQ