Bristol LED Headlight Operating Manual-Rev 4-6 March 2022

Table of Content

Symbol Description...2 Warnings and Cautions...3

Intended Use... 4

Overview...5 Assembly and Operation...6

Headlight Assembly... 6 Controller... 9 Battery... 10 Charging the Battery... 11 Linkage Assembly... 12 Removing the Headlight... 13 Mounting the Headlight... 14

Cleaning and Maintenance...17

Headlight... 17

Specifications...18 Electromagnetic Compatibility...19 Troubleshooting and Service...23 Warranty and Service... 23

Symbol Description 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.

CE marking of conformity indicates this device complies with Regulation (EU) 2017/745 on medical devices, Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, and Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators.

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.

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IEC 60601-1 Edition 4, IEC 60601-1-2 Edition 3, ANSI/AAMI E-S60601-1 (2005), CAN/CSA-C22.2 No. 60601-1 (2008)

2

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

! ! ! ! ! ! ! ! ! !

DO NOT shine light into eyes. Eye injury may result DO NOT use if packaging is damaged. 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 technician Avoid prolonged contact with the headlight during use as it may be hot USE ONLY components and accessories listed on page 5 and 18 of this manual. Failure to do so may decrease system performance, may lead to unsafe operation, may negatively affect EMC performance and could result in non-compliance and could void the warranty WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BristolTM, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 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 of this manual.

3

Warnings and Cautions Intended Use

The Bristol™ 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 eye wear. 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 Bristol™ 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. The intended environment for use is for Professional Health Care except for near active HF Surgical Equipment and the RF shielded room of an ME System for magnetic resonance imaging. Please follow the maintenance instructions on page 17 in order to maintain basic safety.

4

Overview B A D

E C A. B. C. D. E. F. G.

Headlight Headband (accessory) Glasses Clip (accessory) Holster w/ Battery Adjustable Iris Battery Charger (Regular Shown) Charger Power Supply

G

F

5

Assembly and Operation Headlight Assembly NOTE. Your headlight may come pre-installed on the headband or the glasses clip depending on how you ordered it. If your headlight came pre-installed on a headband you may skip to page 7. 1. Attach optic (A) to glasses through use of glasses clip (B) if using glasses.

A

B

2. Attach power cable to glasses using the cable wrap (C) by wrapping it around both the wire and glasses frame.

C A. B. C.

Optic (P002505) Glasses Clip (accessory) (P002327) Cable Wrap (P002331)

6

Assembly and Operation

7

Assembly and Operation 3. Place the battery (D) in the holster (E).

D

D. E. F.

!

E

Battery (P002520) Battery Holster (P002550) Adjustable Iris Only use Long Island Technology Group batteries. Replacement of batteries by untrained personnel could result in dangerous conditions such as fire or explosion.

4. Use the adjustable iris (F) to adjust the spot size from wide to narrow.

F

8

Assembly and Operation Controller

1. Connect headlight cable to holster connector (C), secure treaded cap tightly. 2. Attach the controller to waistband with the controller clip (B). 3. To turn the light on push either of the Side Buttons (A). 4. To increase the light level push either of the Side Buttons (A). 5. The light level starts at the highest level and cycles from high to low. 6. To turn off the light hold both Side Buttons (A) for one second.

C

B

A. B. C.

Side Buttons Holster Clip (P002357) Cable Connector

A

!

Extended Use on high may reduce battery life

9

Assembly and Operation Battery

1. Remove battery by pulling the Retaining Tab (A) or pushing the battery though the access hatch (B) on the back of the holster.

A B A. B.

Retaining Tab Access Hatch

2. To check the battery level press the Battery Fuel Gauge Button (D) on the front of the battery (Four green bars on the Battery Fuel Gauge (C) indicate a full charge). NOTE the holster will beep 10 minutes before end of life.

D C

C. D.

!

Battery Fuel Gauge (State of Charge) Battery Fuel Gauge Button WARNING: To avoid electric shock, DO NOT touch the charger fins

10

Assembly and Operation Charging the Battery

Your BFWTM BristolTM may come with one of two versions of battery chargers shown below. Regular on the left and Mini on the right.

A.

Charging Indicator (See Table Below)* Charging Indicator* Green Blinking Green Solid Red Blinking

A

A

Battery is currently being charged Battery is fully charged An error has occurred during charing

1. Plug the AC Cable (D) into the Power Supply (C). 2. Plug the Power Supply (C) into the Battery Charger (B). 3. Fully charging the Battery before use, will ensure the longest Battery life. When fully charged, remove the battery from charger (B).

D

B. C. D.

Battery Charger Power Supply Charger AC Cable

C

B

11

Assembly and Operation Linkage Assembly

G

F

D E B

A. B. C. D. E. F. G. H.

!

A

H

E

C

Headband (Classic Shown) Headlight Bolt Barrel Washer X 2 Flathead Screwdriver Allen Wrench Set Screw

DO NOT use Thread Locking Glue On the Linkage. Can Cause Irreparable Damage to Linkage Leading to a Hazardous Situations

12

Assembly and Operation Removing the Headlight 1. Use the Allen wrench and Phillips head screwdriver to unlock the binding post.

2. Use the flathead screwdriver and Phillips head screwdriver to unscrew the binding post.

13

Assembly and Operation Mounting the Headlight 3. Place a washer on both sides of the linkage with the concave side towards the linkage.

4. Place the linkage with washers between the fork bar.

14

Assembly and Operation 5. Place the barrel through the left side of the fork bar.

6. Thread the bolt into the right side of the fork bar and tighten the binding post with the flathead and Phillips screwdriver.

15

Assembly and Operation 7. Place the set screw inside the barrel and tighten it using the Allen wrench and Phillips screwdriver.

16

Cleaning and Maintenance Headlight 1. Clean the BristolTM 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 any dust accumulations.

! ! !

DO NOT pour cleaning solution directly on the surface of the BristolTM DO NOT use any sterilization process or cleaning process using excessive heat or humidity as it will damage the device. NEVER immerse the optic in any type of liquid.

Note: Damaging any part of the system with the use of an improper cleaning agent or cleaning process will void all warranties.

17

Specifications Classification

Classification & Type

Class I: Medical Accessory, General Medical Equipment as to fire and mechanical hazards

Environment

Operation Storage Relative Humidity Pressure/Altitude

60 Degrees F (15 C) to 80 Degrees F (26.7 C) 32 Degrees F (0 C) to 104 Degrees F (40 C) 45% - 75% 860 - 1,060 hPa/2,000m

Performance

Illumination Spot Size Spot Control Battery Life by Brightness Setting

Color Temperature

Mechanical

Headlight LxWxH Weight

Electrical

2.25” x .875” x 1” 25g

Device Max Electrical Rating LED Input Voltage 3-3.5 VDC Input Power 3 Watts Max Lamp Life 10,000+ hours Holster Input Voltage 14.4 VDC Input Power 16 Wh

3.5” Diameter Iris, Mechanical Control >28 hours at 8,000 lux (Level 1) >20 hours at 14,000 lux (Level 2) >19 hours at 20,000 lux (Level 3) >13 hours at 24,000 lux (Level 4) >10 hours at 30,000 lux (Level 5) ~7000K CCT Holster w/ Battery LxWxH Weight 11.25V, 1.0A Charge (Regular & Mini) Input Voltage Output Voltage Line Cord (IEC 60320) Battery Output Voltage Capacity

4.75” x 3” x 1.375” 225g

24 VDC, 2.5A 11.25-14.4VDC, 2.0A Maximum Length 10ft 10.8V 3.2Ah

18

Electromagnetic Compatibility Portable and mobile RF communications equipment can affect medical electrical equipment Guidance and manufacturer’s declaration-electromagnetic emissions The Bristol

TM

Immunity Test

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

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 BristolTM, including cables, than the recommended separation distance calculated from the equation application to the frequency of the transmitter. Recommended Separation Distance: Battery Operated Device

Conducted RF IEC 61000-4-6

3 Vrms 150kHz - 80 MHz

3 Vrms

Radiated RF IEC 61000-4-3

3V/meter 80 MHz 2.5 GHz

3V/m from 30MHz to 1GHz, 3V/m for 1 GHz to 25GHz; (1000 Hz 80% Modulated Test Signal)

d = 1.17√P d = 1.17√P 80 MHz to 800 MHz d = 2.23√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 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:

19