Welch Allyn 4607x User Manual

Solid State Portable Headlight System

REF 46070, 46072, 46074, 46076

Symbol Descriptions

Attention: Consult user’s Manual for additional

information

Double Insulation

Part No. 460132 Rev. B

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 Portable 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 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

Set-up and Operation

Instructions for Use

The Solid State Portable Headlight (REF 46070), consisting of Portable
Headlight with soft terry cloth headband (REF 46000) and charger/direct
power source (REF 74170). 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. To adjust the headband, simply move the
Velcro adjustable headband to a comfortable position.

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.

Follow the assembly instructions listed below and the
corresponding photographs.

Headband Adjustment

Headband Replacement

On/Off Switch

Holding 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.

Cleaning (Recommended 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. The terry cloth headband is
removable and is machine washable.

3. Do not operate the light until the light is thoroughly dry.

Do not sterilize the unit.

INTENSE LIGHT

lamp when in use. May be harmful to eyes.

Lamp On

Warnings & Cautions

ATT EN TI ON : Read Operating Manual for Warnings,

Cautions, and Instructions for Use.

IPXØ: Not protected against the ingress of water.

WAR NING : 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.

INTENSE LIGHT

lamp when in use. May be harmful to eyes.

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.

: Lamp is bright. Do not stare at the

Lamp Off

: Lamp is bright. Do not stare at the

Model 46070 (Domestic)
Model 46072 (European)
Model 46074 (U.K.)
Model 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 Domestic
Model 74172 European
Model 74174 U.K.
Model 74176 Australia

On/Off Switch

Input for Charger/
Direct Power Source

Rotate to adjust
spot size.

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.

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.

CAUTION: Do not immerse in cleaning solutions.

Troubleshooting

Trouble

Area

No Light
Output

Low
Light
Output

Possible Cause Corrective Action

Verify that the unit operates on

Dead battery or
battery not connected
properly

Low charge on battery 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

direct power source. If yes,
recharge or replace battery

Specifications

Electrical

Ref

Model

46070 120VAC ± 50/60 Hz 5 volts vdc <10 uA

46072 230VAC ± 50/60 Hz 5 volts vdc <10 uA

46074 230VAC ± 50/60 Hz 5 volts vdc <10 uA

46076 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 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.

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 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.

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 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.

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.

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.

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

Immunity Test

IEC 60601

Test Level

Compliance

Level

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)

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 V r m s
10 V r m s

10 V / m

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
tha n 10 V r ms 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)

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. 10 7 3 . 7 9 5 1. 10 7 2 . 2 14

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

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

US

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.: [phone]
Fax: [phone]

Complies with EMC Framework of Australia

Power Sources

UL Recognized US/Canada

C

UL2601-1, CAN/CSA C22.2 No. 601.1

US

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: [phone]
or 1-[phone]
(North America Only)

INTERNATIONAL Customers

Welch Allyn Germany

Tel: [phone]

Welch Allyn Ltd. Singapore

Tel: [phone]

Latin America

Tel: [phone]

4341 State Street Road
Skaneateles Falls, NY 13153
Tel: [phone] or [phone]
Fax: [phone]
www.welchallyn.com

Canada Customers

Phone: [phone]
or 1-[phone]
(North America Only)

Welch Allyn Australia

Tel: [phone]

Welch Allyn UK Ltd.

Tel: [phone]

Welch Allyn China

Tel: [phone]