Welch Allyn 49026 User Manual

Material No. 460134 Rev. D
Solid State Procedure Headlight System
REF 49020, 49022, 49024, 49026
Symbol Descriptions
Attention: Consult user’s Manual for additional information
Double Insulation
INTENSE LIGHT
when in use. May be harmful to eyes.
Lamp On
: Lamp is bright. Do not stare at the lamp
Lamp Off
Warnings & Cautions
ATTENTION: Read Operating Manual for Warnings,
Cautions, and Instructions for Use.
IPXØ: Not protected against the ingress of water.
WARNING: Solid State Procedure 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.
INTENSE LIGHT
when in use. May be harmful to eyes.
USE ONLY: Solid State Procedure 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 on page 15 for further assistance.
: Lamp is bright. Do not stare at the lamp
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, 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 Procedure Headlight by Welch Allyn, the worldwide leader in 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 the physician’s office, hospital environment, and specialist’s office.
Components
Standard Parts List
Solid State Procedure Headlight with Direct Power Supply
Model 49020 (Domestic) Model 49022 (European) Model 49024 (U.K.) Model 49026 (Australia)
Accessory Parts List
Model 49000 Procedure Headlight Model 49099 Carrying Case Model 72250 Rechargeable Battery
Model 75260 Battery Pack with Charger (Domestic) Model 75262 Battery Pack with Charger (European) Model 75264 Battery Pack with Charger (U.K.) Model 75266 Battery Pack with Charger (Australia)
Replacement Parts List
When ordering replacement parts for your Solid State Procedure Headlight, please use the following numbers
Model 74180 Charger (Domestic) Model 74182 Charger (European) Model 74184 Charger (U.K.) Model 74286 Charger (Australia)
Model 72250 Replacement Battery
Model 75270 Direct Power Supply (Domestic) Model 75272 Direct Power Supply (European) Model 75274 Direct Power Supply (U.K.) Model 75276 Direct Power Supply (Australia)
Set-up and Operation
Instructions for Use
The Solid State Procedure Headlight (REF 49020), consisting of Procedure Headlight (REF 49000) with Direct Power Source (REF 75270), and Accessory Portable Power Source/Charger (REF 75260). The Solid State Procedure Headlight is designed to operate off the direct or the portable power source. To operate the headlight using the direct power source, follow the instructions and illustrations in the section labeled Direct Plug-In Transformer. Simply turn on the on/off switch located on the Direct Plug to operate the headlight. To operate the headlight using the portable power source, follow the instructions and illustrations under the section labeled “Connecting Headlight to Portable Power source”.
To recharge the portable power source, follow the instructions and illustrations in the “Recharging the Portable Power source” section. To adjust the light spot size, turn the knob on the front section of the luminaire. To adjust the headband, simply rotate the adjustment knob located on the back of the headband.
Use the Solid State Procedure Headlight to provide illumination while performing a number of activities in the physician’s office, hospital, or emergency environment such as minor surgery, general exam, foreign body removal, OB/GYN applications/procedures, dermatology examinations or any procedure which requires a small, homogenous, and well-defined spot.
Follow the assembly instructions listed below and the corresponding illustration.
Connecting Headlight to Portable Power Source
1. Plug the instrument power cord into the power cord connector port on
the top of the power source.
2. Push in until it is firmly in place.
3. Gently screw the external connector sleeve clockwise to secure.Recharging the Portable Power Source
Portable Power Source
Instrument Power Cord
Recharging the Portable Power Source
1. Turn the portable power source off.
2. Disconnect instrument from power source.
3. Plug charging transformer into portable power source.
4. Plug charging transformer into wall socket. LED light indicates unit is charging.
5. Disconnect charging transformer from power source when fully charged, approximately 10 - 12 hours.
On/Off Switch
Maintenance
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.
Cleaning (Recommonded Monthly)
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.
3. Do not operate the light until the light is thoroughly dry.
Do not sterilize the unit.
CAUTION: Do not immerse in cleaning solutions.
Battery Replacement
Screws
Step 1 Step 2
Step 3 Step 4
1. Verify power is off.
2. Remove both screws from back of p ower source with Phillips head screwdriver (figure 1).
3. Grasp the belt clip, gently pull back and down on the housing (figure 2 and 3).
4. Lift battery out and unplug from unit.
5. Replace with new battery and reverse above steps.
Securely tighten the power source housing screws in order to properly hold electrical components in place.
Direct Plug-In Transformer
1. Plug Power cord from the Solid State Procedure Headlight into the Direct Plug-In Power cord.
2. Push until firmly in place.
3. Gently screw the external connector sleeve clockwise to secure.
4. The instrument is now ready for use.
5. Plug direct power source into a nearby receptacle.
Troubleshooting
Trouble
Area
No Light Output
Low Light Output
Possible Cause Corrective Action
Verify that the unit operates on direct power source. If yes, insure that the battery is connected
Dead battery or battery not connected properly
Low charge on battery
properly; refer to the battery replacement section for instructions on connecting the battery. If the battery is connected properly, recharge or replace battery
Verify that the unit operates on direct power source. If yes, recharge or replace battery
Specifications
Electrical
Ref
Model
49020 120VAC ± 50/60 Hz 5 volts vdc <10 uA
49022 230VAC ± 50/60 Hz 5 volts vdc <10 uA
49024 230VAC ± 50/60 Hz 5 volts vdc <10 uA
49026 240VAC ± 50/60 Hz 5 volts vdc <10 uA
Input Voltage
Output
Voltage
Leakage Current
Emissions and Immunity Information
Guidance and Manufacturer’s Declaration - Emissions The REF 49000 is intended for use in the electromagnetic environment
specified below. The customer or user of the REF 49000 should ensure that it is used insuch an environment.
Emissions
Test
RF Emissions CISPR11 Group 1
RF Emissions CISPR11 Class B
Harmonics IEC 61000-3-2 Class A
Flicker IEC 61000-3-3 Complies
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 49000 is intended for use in the electromagnetic environment
specified below. The customer or user of the REF 49000 should ensure that it is used in such an environment.
Immunity Test
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips/ Dropout IEC 61000-4-11
Power Frequency
Compliance
IEC 60601
Test Level
± 6kV Contact
± 8kV Air
±2kV Mains
±1kV I/Os
±1kV Differential
±2kV Common
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
3 A/m 3 A/m
50/60Hz
Magnetic Field
IEC 61000-4-8
Electromagnetic Environment -
Guideance
The REF 49000 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.
The REF 49000 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.
Compliance
Level
± 8kV Contact
± 15kV Air
±2kV
±2kV
±2kV
±2kV
>95% Dip for
0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
Electromagnetic
Environment -
Guidance
Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the r/h should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commerical or hospital environment.
Mains power quality should be that of a typical commerical or hospital environment.
Power frequency magnetic fields should be that of a typical commerical or hospital environment.
Guidance and Manufacturer’s Declaration - Immunity The REF 49000 is intended for use in the electromagnetic environment
specified below. The customer or user of the REF 49000 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 REF 49000 by no less than the distances calculated/listed below:
D=0.35 (Sqrt P)
D=1.2 (Sqrt P)
D=0.35 (Sqrt P)
80 to 800 MHz
Where P is the max power in watts and D is the recommended separation distance in meters.
Field strengths from
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
3 Vrms (Ouside ISM) 10Vrms (In ISM Bands) 150 kHz to 80MHz
10 V/m 80 MHz to 2.5 GHz
10 Vrms 10 Vrms
10 V/m
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 49000
The REF 49000 is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the REF 49000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the REF 49000 as recommended below, according to the maximum output power of the communications equipment.
Separation (m)
Max Output Power
(Watts)
0.01 0.035 0.12 0.035 0.07
0.1 0.111 0.379 0.111 0.221
1 0.35 1.2 0.35 0.7
10 1.107 3.795 1.107 2.214
100 3.5 12.0 3.5 7.0
150kHz to
80MHz
Non-ISM
D=(3.5/V1)
(Sprt P)
Separation (m)
150kHz to
80MHz
ISM
D=(12/V2)
(Sprt P)
Separation (m)
80 to 800MHz
D=(3.5/E1)
(Sprt P)
Separation (m)
800MHz to
2.5GHz
D=(7/E1)
(Sprt P)
Dimensions
Headband Adjustment Range Small, Medium, Large
Illumination System
5 watt Solid State Lamp Color Temperature 5500 Degree Kelvin 50 Lumens LED life > 10,000 hours Working distance 16 inches Spot size range 1.5 to 6 inches at the working distance
Weight
6 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 IPXØ: 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
ETL Listed: CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 CONFORMS TO: IEC 60601-1,IEC 60601-1-2, UL STD
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 Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland
Complies with EMC Framework of Australia
Power Sources
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 Procedure 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
Welch Allyn Ltd. Singapore
Tel: +65 6419 8100
Welch Allyn Latin America
Tel: +1 305 669 9003
4341 State Street Road Skaneateles Falls, NY 13153 Tel: (800) 535-6663 or (315) 685-4560
www.welchallyn.com
Canada 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
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