Solid State Portable Headlight System - Directions For
Contents
1. UL Recognized US Canada UL2601 1 CAN CSA C22 2 No 601 1 VDE Certified IEC 60601 1 EN 60601 1 VDE 0750 Warranty Instrumentation purchased new from Welch Allyn Inc Welch Allyn is warranted to be free from original defects in material and workmanship under normal use and service for a period of one year for the Solid State Portable Headlight from the date of first shipment from Welch Allyn This warranty shall be fulfilled by Welch Allyn or its authorized representative repairing or replacing at Welch Allyn s discretion any such defect free of charge for parts and labor Welch Allyn should be notified via telephone of any defective product and the item should be immediately returned securely packaged and postage prepaid to Welch Allyn Loss or damage in shipment shall be at the purchaser s risk Welch Allyn will not be responsible for loss associated with the use of any Welch Allyn product that 1 has had the serial number defaced 2 has been repaired by anyone other than an authorized Welch Allyn Service Representative 3 has been altered or 4 has been used in a manner other than in accordance with the instructions Service Information For Technical Support or to obtain return instructions please contact the nearest Welch Allyn service center listed below USA Customers Phone 1 315 685 4560 or 1 800 535 6663 North America Only INTERNATIONAL Customers Welch Allyn Germany Tel 49 695 098 5132 Can2. 2 5GHz D 7 E1 Sprt P Separation m 80 to 800MHz D 3 5 E1 Sprt P Dimensions Headband Adjustment Range small Medium Large Illumination System 1 watt Solid State Lamp Color Temperature 5500 Degree Kelvin 20 Lumens LED lite gt 10 000 hours Working distance 16 inches Spot size range 1 5 to 6 inches at the working distance Weight 4 ounces Environment Operating 32 F 104 F 0 C 40 C 75 RH Max continuous 500 hPa 1060 Altitude storage Transport 4 F 120 F 20 C 49 C 95 RH Max continuous 500 hPa 1060 Altitude Equipment Classification Class II Continuous Operation IPX Not protected against the ingress of water Category Not AP APG Equipment This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices As a precaution avoid using this device in close proximity to other equipment Approvals CERTIFIED TO CAN CSA STD C22 2 NO 601 1 c eih us CONFORMS TO IEC 60601 1 IEC 60601 1 2 UL STD LISTED 60601 1 AS NZS 3200 1 The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive Regulatory Affairs Representative Welch Allyn Limited EC Navan Business Park Dublin Road Navan County Meath Republic of Ireland Complies with EMC Framework of Australia Power Sources
3. Domestic Model 74172 European Model 74174 U K Model 74176 Australia Set up and Operation Instructions for Use The Solid State Portable Headlight consists of a Portable Headlight with soft terry cloth or rigid headband and a charger direct power source The Solid State Portable Headlight is designed to operate off the battery or direct power source The headlight is provided fully assembled to operate in the portable operation mode All headlights are shipped with the batteries discharged Charge the batteries prior to use Once the unit is charged turn the power switch located at the top of the luminaire to the on position To operate the headlight using the direct power source insert the charger direct power source REF 74170 into the input port located on the top of the luminaire see photo below To charge the battery pack connect the charger direct power source REF 74170 into the top of the luminaire see photo below To adjust the spot size rotate the front section of the luminaire Use the Solid State Portable Headlight to provide illumination while performing a number of activities in the physician s office hospital or emergency environment such as minor suturing general exam and foreign body removal NOTE Follow the assembly instructions listed below and the corresponding photographs Headband Adjustment On Off Switch Rotate to adjust a Spot size Input for Charger Direct Power Source Maint
4. and taking additional precautions when skin sensitivity has been altered through tissue trauma or the use of anesthesia General good practices to minimize risk of harm to the eyes from optical radiation hazards include Avoiding looking at bright light sources and their reflections and protect eyes where normal pupil sizes and aversion responses are not present Introduction Thank you for purchasing the Solid State Portable Headlight by Welch Allyn the worldwide leader tn illuminated medical diagnostic instrumentation By following the use and care guidelines supplied in this owner s manual you will enjoy years of dependable trouble free service from your new headlight This headlight is designed to meet the various needs of a physicians office hospital environment and wherever compact portable direct illumination is critical Components Standard Parts List Solid State Portable Headlight and Power Cord Charger Rigid Headband model 46070R Domestic 46072R European 46074R U K 46076R Australia Terrycloth Headband model 46070 Domestic 46072 European 46074 U K 46076 Australia Accessory Parts List Model 05232 U Soft Case Replacement Parts List When ordering replacement parts for your Solid State Portable Headlight please use the following numbers Model 49642 Soft Terrycloth Headband case of 10 Model 72270 Rechargeable Battery Direct Power Source Charger Model 74170
5. should be at least 30 Mains power quality should be that of a typical commercial or hospital environment EFT 2kV Mains IEC 61000 4 4 1kV I Os 1kV Differential 2kV Common Mains power quality should be that of a typical commerical or hospital environment Surge IEC 61000 4 5 Voltage Dips Dropout IEC 61000 4 11 gt 95 Dip for 0 5 Cycle gt 95 Dip for 0 5 Cycle Mains power quality should be that of a typical commerical or hospital environment 30 Dip for 25 Cycles 60 Dip for 5 Cycles 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds gt 95 Dip for 5 Seconds Power frequency magnetic fields should be that of a typical commerical or hospital environment Power Frequency 3 A m 50 60Hz Magnetic Field IEC 61000 4 8 ESD EFT and Surge testing were performed on the FRIWO 15 1504 power supply at 100 and 240 VAC Voltage Dips were tested at 100 and 240 VAC and Magnetic Immunity was tested at 50 and 60 Hz A REF 46000 was connected for both Voltage Dips and Magnetic Immunity testing Guidance and Manufacturer s Declaration Immunity The REF 46000 is intended for use in the electromagnetic environment specified below The customer or user of the REF 46000 should ensure that it is used in such an environment Electromagnetic Environment Guidance IEC 60601 Test Level Compliance Level Immunity Test Portable and mobile communica
6. the luminaire with the on off switch in the up position place the visor section of the luminaire into the openings located in the front section of the terry cloth headband Weleh Allyn Cleaning Recommended monthly NOTE Excess solution entering the luminaire assembly could damage internal components Use caution to ensure cloth is not saturated with solution 1 Unplug the unit prior to cleaning 2 Wipe down the entire luminaire with a cloth slightly dampened with a mild solution of detergent The terry cloth headband is removable and is machine washable 3 Do not operate the light until the light is thoroughly dry NOTE Do not sterilize the unit CAUTION Do not immerse in cleaning solutions Troubleshooting Trouble Corrective Action Area Possible Cause Verify that the unit operates on direct power source If yes insure that the battery is connected properly refer to the battery replacement section for instructions on connecting the battery If the battery is connected properly recharge or replace battery Dead battery or battery not connected properly Low charge on battery Verify that the unit operates on direct power source If yes recharge or replace battery Specifications Electrical Output Voltage Leakage Current Ref Input Voltage Emissions and Immunity Information Guidance and Manufacturer s Declaration Emissions The REF 46000 is intended for use in the electromagnet
7. Material No 715350 Ver B WelchAltyn Solid State Portable Headlight System REF 46070 46072 46074 46076 46070R 46072R 46074R 46076R Symbol Descriptions Attention Consult user s Manual for additional information Double Insulation El e INTENSE LIGHT Lamp is bright Do not stare at the lamp when in use May be harmful to eyes je ATTENTION Read Operating Manual for Warnings Cautions and Instructions for Use l C ome Lamp On Lamp Off i Warnings amp Cautions IPX Not protected against the ingress of water WARNING Solid State Portable Headlight is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide An explosion may result Pee INTENSE LIGHT Lamp is bright Do not stare at the lamp when in use May be harmful to eyes l 7 N l USE ONLY Solid State Portable Headlight Power Source Battery Charger and rechargeable battery pack supplied by Welch Allyn There are no user serviceable parts inside the device except the rechargeable batteries and headband Contact the Authorized Service Center listed at the end of this document for further assistance gt e Guidelines for the safe use of the Solid State Portable Headlight General practices to minimize risk of harm to the skin from optical radiation hazards include minimizing illumination intensity at the tissue examination site minimizing exposure times
8. ada Customers Phone 905 890 0004 or 1 800 561 8797 North America Only Welch Allyn Australia Tel 61 2 9638 3000 Welch Allyn UK Ltd Tel 44 20 7365 6780 Welch Allyn China Tel 86 216 327 9631 Welch Allyn Ltd Singapore Tel 65 6419 8100 Welch Allyn Latin America Tel 1 305 669 9003 WelchAllyn 4341 State Street Road Skaneateles Falls NY 13153 Tel 1 800 535 6663 or 1 315 685 4560 www welchallyn com
9. enance Each month examine cords and connections The user can perform battery and or headband replacement on an as needed basis Return the unit to an authorized Welch Allyn Technical Service Department or distributor for additional servicing See Service and Warranty Information section Battery Charging The fully drained battery will reach a 90 charge retention in approximately three hours of continuous charging This is approximately 25 longer if the charging is happening at a temperature less than 15 C Proportional usage will require a proportional charge time such as if the product is used for 15 minutes charge the battery for 45 minutes to reach a 90 capacity Overnight charging brings the battery to its 100 full capacity Charging the unit while operating will significantly increase the charge time to over 12 hours to obtain a 90 charge level This battery pack does not exhibit any memory problems that exist with NiCad batteries However like other products where batteries are used remove the battery from the product when the product is in storage or when not in use for extended periods beyond 6 months If the battery is left in the product for extended periods of time the battery will drain down to an unusable level and require charging prior to use Battery Replacement Drop the battery pack into the luminaire visor and plug into the connector Headband Replacement x On Off Switch Holding
10. ic environment specified below The customer or user of the REF 46000 should ensure that it is used insuch an environment Emissions Electromagnetic Environment Compliance Test Guideance The REF 46000 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 RF Emissions CISPR11 Class B Harmonics IEC 61000 3 2 Class A Flicker IEC 61000 3 3 Complies The REF 46000 is suitable for use in all establishments including domestic and those directly connected to the public low voltage power supply network that supplies buidlings used for domestic purposes Radiated and Conducted Emissions were tested on the FRIWO 15 1504 power supply It complies with the EN55022 Class B limits same limits as EN55011 Group 1 Class B Harmonics and Flicker testing were performed on a REF 46000 with a 230 VAC FRIWO 15 1504 power supply Guidance and Manufacturer s Declaration Immunity The REF 46000 is intended for use in the electromagnetic environment specified below The customer or user of the REF 46000 should ensure that it is used in such an environment ESD 6kV Contact IEC 61000 4 2 8kV Air RF Emissions CISPR11 Electromagnetic Environment Guidance IEC 60601 Test Level Compliance Level 8kV Contact Floors should be l wood concrete 15kV Air or ceramic tile If floors are synthetic the r h
11. tions equipment should be separated from the REF 46000 by no less than the distances calculated listed below D 0 35 Sart P D 1 2 Sart P D 0 35 Sart P 80 to 800 MHz Where P is the max power in watts and D is the recommended Me ie io 25 separation distance In GHz meters Conducted RF 3 Vrms Ouside 10 Vrms IEC 61000 4 6 ISM 10 Vrms 10Vrms In ISM Radiated RF Bands IEC 61000 4 3 150 kHz to SOMHz 10 V m Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less than 10Vrms or 10V m Interference may occur in the vicinity of equipment containing a transmitter Conducted RFI and Radiated RFI testing was performed on a FRIWO 15 1504 power supply monitoring the output for drops in voltage none were detected Recommended Separations Distances between portable and mobile RF Communications equipment and the REF 46000 The REF 46000 is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the REF 46000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the REF 46000 as recommended below according to the maximum output power of the communications equipment Separation m 150kHz to 150kHz to 80MHz 80MHz Non ISM ISM D 3 5 V1 D 12 V2 Sprt P Sprt P Separation m Separation m 800MHz to
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