BFW Daymark Operating Manual

Symbol Description......................................................................................2 Warnings and Cautions.................................................................................3 Intended Use................................................................................................................ 4 Unintended Uses.......................................................................................................... 4 Overview......................................................................................................5 System Description....................................................................................................... 5 Assembly and Operation..............................................................................6 Ferrite........................................................................................................................... 6 Headlight...................................................................................................................... 7 Classic Headband.......................................................................................................... 8 Key West Headband..................................................................................................... 8 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

meaning. Attention: Read this owner’s manual for all warnings, precautions and instructions for use. CE marking of conformity indicates this device complies with European Directive 93/42 EC on medical devices and Directive 2002/95/EC on the restriction of the use of certain hazard- ous substances in electrical and electronic equipment. The UL mark indicates this product has been tested to, and conforms to applicable stan- dards. 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)

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. ! ! WARNING! NEVER direct the device light beam into the eyes of anyone. Strong light emitted from the device can cause damage or injury. ! ! Read and understand the Device Operating Manual before using the device. ! ! Avoid prolonged physical contact with the headlight during use as it may be warm. ! ! Standard Working Distance is 16 inches (40 cm) minimum. Use caution when operating at closer dis- tances. ! ! DO NOT use devices for direct illumination of the eye. ! ! DO NOT use multiple units simultaneously to illuminate the same area. High intensity illumination can harm tissue. ! ! Use DaymarkTM only with BFWTM/Long Island Technology GroupTM products or accessories. ! ! RX Only: United States Federal Law restricts this device to sale by or on the order of a health care pro- fessional. ! ! DO NOT subject the DaymarkTM to strong shocks, which include but are not limited to dropping the device on the floor. ! ! DO NOT use this device for anything other than its intended use. ! ! DO NOT modify this equipment. ! ! DO NOT open device. No serviceable components are inside device. ! ! Only Qualified Personnel should operate the BFWTM DaymarkTM ! ! DO NOT submerge the device or any of its components in liquid.

! ! DO NOT use if packaging is damaged. ! ! 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 DaymarkTM, in- cluding cables specified by the manufacturer. Otherwise, degradation of the performance of this equip- ment 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. Intended Use The BFWTM DaymarkTM LED Headlight is a device intended to supply supplemental, constant and con- trolled illumination during medical procedures. This device is designed for use in the operating room. The advantage of the DaymarkTM system is that the light is positioned between the medical professional’s eyes and the direction of illumination is always in the exact direction of the medical professional’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 assembly instructions on page 6 and maintenance instructions on page 17 in order to maintain basic safety.

aluminum lens system holder with glass anti-reflective coated lenses and a spot size adjusting iris. Light is provided by a high power LED, driven by a solid state controller and battery to provide ON/OFF and 5 levels of light output. The system includes two spare batteries and a battery charging system. The device is articulated, allowing the lower part of the light to be turned left and right for ease of aiming. As shown below the device is attached to a headband, which allows the medical professional to wear the headlight on their head. The headband mounting system adjusts for comfortable fit and allows the light to be adjusted for position between the user’s eyes so illumination is shadow free. Two styles of headbands are available, the Classic headband as shown below, constructed of plastic with knobs for size adjustment, and the Key West headband, designed to be lighter and more comfortable. (not shown) A B C D E F G A. DaymarkTM LED Headlight B. Headband (accessory) Classic Headband (shown above) Key West Headband (not shown) C. Power Cable D. Battery E. Battery Holster/Controller F. Battery Charger (Regular Shown) G. Battery Charger Power Supply

Ferrite 1. Open the Ferrite by pulling on the tab. 2. Attach the provided Ferrite onto the Power Cable close to the connector over-mold. ! ! DO NOT use the DaymarkTM without the Ferrite as it may result in non-compliant EMC levels.

Headlight A B C D A. Headlight Front Lens B. Iris Adjustment Ring C. Power Cable D. Mounting Linkage DaymarkTM Operation: 1. The lower portion of the headlight (below the Iris Adjustment Ring) can be turned a small amount to the left and right to facilitate aiming the light. 2. The Iris Adjustment Ring (B) allows for variation of the spot size projected by the headlight. The Mounting Linkage (D) is adjustable for vertical aiming and position adjustment.

Classic Headband A Key West Headband B A A. Adjustment Knobs Classic Headband Adjustment: 1. Turn the Adjustment Knobs (A) to tighten or loos- en the headband. A. Adjustment Tab B. Release Button Key West Headband Adjustment: 1. To tighten pull on the Adjustment Tab (A). 2. To loosen press the Release Button (B) and pull on the front of the headband away from the back.

Controller A B C A. Power Connector B. Battery Holster and Battery C. Side Buttons Battery Holster/Controller: 1. Connect headlight cable to Power Connector (A), secure threaded cap tightly. 2. Attach the holster to waistband with the holster clip. 3. To turn the light on, push either of the Side Buttons (C). 4. To decrease the light level, push either of the Side Buttons (C). 5. The light level cycles from High to Low (5 levels). 6. To turn off the light, hold both Side Buttons (C) for one second.

Battery Your BFWTM DaymarkTM will come with one of two versions of the 4-cell batteries shown below. 1. To Remove the battery from the holster pull the Retaining Tab (A) or pushing the battery though the Ac- cess Hatch (B) on the back of the holster. B A A. Retaining Tab B. Access Hatch 2. To check the battery level, either look through the window on the bottom of the holster (Five black bars on the Battery Fuel Gauge (C) indicate a full charge) or 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 hol- ster will beep 15 minutes before end of life. At 5 minutes before end of life, the brightness will be limited to the two lowest levels. C C D C. Battery Fuel Gauge (State of Charge) D. Battery Fuel Gauge Button ! ! Leaving a battery in the holster will slowly drain its charge.

Charging the Battery Your BFWTM DaymarkTM may come with one of two versions of battery chargers shown below. Regular on the left and Mini on the right. A A A. Charging Indicator (See Table Below)* Charging Indicator* Green Blinking Battery is currently being charged Green Solid Battery is fully charged Red Blinking 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 B. Battery Charger C. Power Supply D. Charger AC Cable

Linkage Assembly A B C D E F G H A. Headband (Classic Shown) B. Headlight C. Bolt D. Barrel E. Washer X 2 F. Set Screw G. Flathead Screwdriver H. Allen Wrench ! ! DO NOT use Thread Locking Glue On the Linkage. Can Cause Irreparable Damage to Linkage Leading to a Hazardous Situations

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.

Mounting the Headlight 3. Put the linkage in-between the fork bar. 4. Place the washers concave side towards the fork on the outsides of the fork.

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 Phil- lips screwdriver.

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

Headlight 1. Clean the DaymarkTM 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 DaymarkTM ! ! 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 improper cleaning agent or cleaning process will void all warranties.

Class I: Medical Accessory, General Medical Equip- ment as to fire and mechanical hazards Environment Operation 60 Degrees F (15 C) to 80 Degrees F (26.7 C) Storage 23 Degrees F (0 C) to 104 Degrees F (40 C) Relative Humidity 45% - 75% Pressure/Altitude 860 - 1,060 hPa/2,000m Performance Illumination Spot Size 4” Diameter Spot Control Iris, Mechanical Control Battery Life by Brightness Setting 25 hours at 15,000 lux (Level 1) 12 hours at 30,000 lux (Level 2) 09 hours at 40,000 lux (Level 3) 07 hours at 50,000 lux (Level 4) 05 hours at 60,000 lux (Level 5) Color Temperature ~5000K CCT Color Rendering Index 78 Mechanical Headlight Holster w/ Battery LxWxH 2.25” x 1.25” x 3.25” LxWxH 4.75” x 3” x 1.375” Weight 25g Weight 225g Electrical Device Max Electrical Rating 14.4V, 2A LED Charge (Regular & Mini) Input Voltage 3-3.5 VDC Input Voltage 24 VDC, 2.5A Input Power 8 Watts Max Output Voltage 11.25-14.4VDC, 2.0A Lamp Life 10,000+ hours Line Cord (IEC 60320) Maximum Length 10ft Holster Battery Input Voltage 14.4 VDC Output Voltage 14.0V Input Power 45 Wh Capacity 3.2Ah

Guidance and manufacturer’s declaration-electromagnetic emissions The DaymarkTM is intended for use in the electromagnetic environment specified below. The customer or the user of the DaymarkTM 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 Radiated RF IEC 61000-4-3 3 Vrms 150kHz - 80 MHz 3V/meter 80 MHz - 2.5 GHz 3 Vrms 3V/m from 30MHz to 1GHz, 3V/m for 1 GHz to 25GHz; (1000 Hz 80% Modulated Test Signal) Portable and mobile RF communications equipment should be used no closer to any part of the DaymarkTM, including cables, than the recom- mended separation distance calculated from the equation application to the frequency of the transmitter. Recommended Separation Distance: Battery Operated Device 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 recom- mended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electro- magnetic 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 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects, and people. (1) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, am- ateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy to asses the electromag- netic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DaymarkTM is used exceeds the applicable RF compliance level above, the DaymarkTM should be observed to verify normal operation. IF abnormal performance is observed, additional measure may be necessary, such as re-orienting or relocating the DaymarkTM. (2) Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the DaymarkTM The DaymarkTM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus- tomer or user of the DaymarkTM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DaymarkTM as recommended below, according to the maximum output power of the communications equipment. Rate maximum output power of transmitter Separation distance according to frequency of transmitter in meters W 150 kHz to 80 MHz d = 1.17 P 80 MHz to 800 MHz d = 1.17 P 800 MHz to 2.5 GHz d = 2.23 P .01 0.12 0.12 0.23 .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 esti- mated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the trans- mitter 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 ISM (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; 26.957 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 dis- tance 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 guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from surfaces, objects, and people.

The DaymarkTM is intended for use in the electromagnetic environment specified below. The customer or the end user of the Day- markTM should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic dis- charge (ESD) IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic mate- rial, the relative humidity should be at least 30 %. The user of the (DaymarkTM) should avoid situations that could result in excess electro- static discharge. Radiated RF electro- magnetic field IEC 61000-4-3 3 V/m 80 % AM at 1 kHz IEC 61000-4-3 3 V/m 80 % AM at 1 kHz Radiated RF levels should be that of a typical commercial or hospital environment Proximity fields from RF wireless communications equipment IEC 61000-4-3 See Table 9 on page 22. IEC 61000-4-3 See Table 9 on page 22. RF wireless communications equipment should be used no closer than 30 cm to the DaymarkTM. Electrical Fast Tran- sient/burst IEC 61000-4-4 ± 2 kV for power supply lines 100kHz repetition frequency IEC 61000-4-4 ± 2 kV for power supply lines 100kHz repetition frequency Mains power quality should be that of a typi- cal commercial or hospital environment. Surge IEC 61000-4-5 ± 0,5 kV, ± 1 kV line(s) to line(s) ± 0,5 kV, ± 1 kV, ± 2 kV line(s) to earth IEC 61000-4-5 ± 0,5 kV, ± 1 kV line(s) to line(s) ± 0,5 kV, ± 1 kV, ± 2 kV line(s) to earth Mains power quality should be that of a typi- cal commercial or hospital environment. Conducted Distur- bances induced by RF fields IEC 61000-4-6 3 V 0,15 MHz - 80MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz IEC 61000-4-6 3 V 0,15 MHz - 80MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz Mains power quality should be that of a typi- cal commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycle IEC 61000-4-11 0 % UT; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycle Mains power quality should be that of a typi- cal commercial or hospital environment. If the user of the DaymarkTM requires contin- ued operation during power mains interrup- tions, it is recommended that the DaymarkTM be powered from an uninterruptible power supply or a battery. NOTE UT is the a.c. mains voltage prior to application of the test level.

The DaymarkTM is intended for use in the electromagnetic environment specified below. The customer or the end user of the Day- markTM should assure that it is used in such an environment. Emissions Test IEC 60601 test level Compliance level Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 Group 1 The DaymarkTM uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interfer- ence in nearby electronic equipment. RF emissions CISPR 11 Class A Class A The DaymarkTM is suitable for use in all estab- lishments other than domestic and those direct- ly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions IEC 61000-3-2 Class A Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Complies NOTE  The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-ori- enting the equipment. Table 9 - Test specifications for Enclosure Port Immunity to RF wireless communications equipment Test frequency (MHz) Band (MHz) Service Modulation Maximum power (W) Distance (m) Immunity Test Level (V/m) 385 380 - 390 TETRA 400 Pulse modulation 18Hz 1,8 0,3 27 450 430 - 470 GMRS 460, FRS 460 FM ± 5Hz deviation 1 kHz sine 2 0,3 28 710 704 - 787 LTE Band 13, 17 Pulse modulation 217 Hz 0,2 0,3 9 745 780 810 800 - 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation 18Hz 2 0,3 28 870 930 1720 1700 - 1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation 217 Hz 2 0,3 28 1845 1970 2450 2400 - 2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation 217 Hz 2 0,3 28 5240 5100 - 5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0,2 0,3 9 5500 5785

Symptom Possible Issue Solution No Light Output Battery is out of charge Recharge the battery Battery is not functioning Send battery for repair Headlight is overheating Clean headlight and remove ob- structions Controller is broken Send Controller for repair Inability to change light level Controller is broken Send Controller for repair Low Light Output LED is nearing end of life Send Headlight for repair Controller is set to a low level Increase level via the controller Lens is dirty Clean the lens using the instruc- tions provided in this manual Headlight is running hot Clean headlight and remove ob- structions Battery charge is critically low Recharge the battery Warranty and Service Warranty against manufacturer’s defects applies to the following components of the Daymark™ under normal use for one (1) year from the date of sale from Long Island Technology Group (includes parts and labor). • LED Optics • Headband • Mounting Linkage The warranty does not cover products damaged by the following: • Accident, misuse, abuse, or alteration • Servicing by unauthorized persons • Use with unauthorized accessories In all cases Long Island Technology Group, reserves the right to determine the cause of all malfunctions and at its sole discretion will determine the damage and/or repairs that are covered under this warranty. Send All Inquires To: Long Island Technology Group, LLC 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 Géné ral Wahis 53 1030 Brussels, Belgium Tel: +(32) 2.732.59.54 Fax: +(32)2.732.60.03 Email: [email protected]

(631) 270-4463 litgp.com Scan Here to See All Long Island Technology GroupTM Manuals Or Visit: http://www.litgp.com/manuals Revision 2.5 9/30/2019 Contents are fragile. Contains Li-on batteries, Handle with care. Conforms to: IEC 60601-1 Edition 4, IEC 60601-1-2 Edition 3 AAMI ES60601-1 Edition 1, CSA C22.2 NO 60601-1:08 Edition 2 Manufactured by Long Island Technology Group, LLC 60 Carolyn Blvd, Farmingdale, NY 11735