Welch Allyn 4607x Solid State Portable Headlight System - User Manual - Manual (Page 2)

Emissions and Immunity Information
Guidance and Manufacturer’s Declaration - Emissions
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 insuch an environment.
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, 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.
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.
Dimensions
Headband Adjustment Range Small, Medium, Large
Illumination System
1 watt Solid State Lamp
Color Temperature 5500 Degree Kelvin
20 Lumens
LED life > 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
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
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.
Authorized European Representative Address:
European Regulatory Manager
Welch Allyn Ltd.,
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland.
Tel.: 353-46-90-67700
Fax: 353-46-90-67756
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
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:
4341 State Street Road
Skaneateles Falls, NY 13153
Tel: (800) 535-6663 or (315) 685-4560
Fax: (315) 685-3361
www.welchallyn.com
Emissions
Test
Compliance
Electromagnetic Environment -
Guideance
RF Emissions
CISPR11
Group 1
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.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment -
Guidance
ESD
IEC 61000-4-2
± 6kV Contact
± 8kV Air
± 8kV Contact
± 15kV Air
Floors should be
wood, concrete,
or ceramic tile. If
floors are
synthetic, the r/h
should be at least
30%.
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
±2kV
±2kV
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
±2kV
±2kV
Mains power
quality should be
that of a typical
commerical or
hospital
environment.
Voltage Dips/
Dropout
IEC 61000-4-11 >95% Dip for 0.5
Cycle
60% Dip for 5
Cycles
30% Dip for 25
Cycles
>95% Dip for 5
Seconds
>95% Dip for
0.5 Cycle
60% Dip for 5
Cycles
30% Dip for 25
Cycles
>95% Dip for 5
Seconds
Mains power
quality should be
that of a typical
commerical or
hospital
environment.
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m Power frequency
magnetic fields
should be that of
a typical
commerical or
hospital
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 (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
Portable and mobile
communications
equipment should be
separated from the REF
46000 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
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.
Max
Output
Power
(Watts)
Separation (m)
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)
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
US
C US
USA Customers
Phone: 1-(315) 685-4560
or 1-(800) 535-6663
(North America Only)
Canada Customers
Phone: (905) 890-0004
or 1-(800) 561-8797
(North America Only)
INTERNATIONAL Customers
Welch Allyn Germany
Tel: (+49) 7477 9271 70
Welch Allyn Australia
Tel: (+61) 2 9638-3000
Welch Allyn Ltd. Singapore
Tel: (+65) 6291 0882
Welch Allyn UK Ltd.
Tel: 0-207-365-6780
Latin America
Tel: 1-(305) 669-9003
Welch Allyn China
Tel: (+86) 21-63279631