Welch Allyn KleenSpec 789 Series Manual

Welch Allyn® KleenSpec
78900 and 78950 
Corded Illumination System
Directions for use

© 2017 Welch Allyn. All rights are reserved. To support the intended use of the product
described in this publication, the purchaser of the product is permitted to copy this
publication, for internal distribution only, from the media provided by Welch Allyn. No other
use, reproduction, or distribution of this publication, or any part of it, is permitted without
written permission from Welch Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper
use of the product, that may result from failure to use this product in accordance with the
instructions, cautions, warnings, or statement of intended use published in this manual.
For patent information, visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact your local Welch Allyn
representative: http://www.welchallyn.com/en/other/contact-us.html.
80021431 Ver B
Revised: 2017-01 This manual applies to 901070 VAGINAL SPECULUM LIGHTING SYSTEM
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland

Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Symbol Descriptions . . . . . . . . . . . . . . . . . . . . . . 1
Warnings and Cautions . . . . . . . . . . . . . . . . . . . . 2
Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . 3
KleenSpec Corded Illumination System . . . . . . . . . . 3
Inserting the Illuminator . . . . . . . . . . . . . . . . . . . 4
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . 4
Lamp Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . 6
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . 9
Warranty and Service . . . . . . . . . . . . . . . . . . . . 10
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Emissions and immunity information . . . . . . . 11

1-1
Introduction
Intended use
When used with the vaginal speculum, the illuminator provides illumination during
pelvic examinations and other gynecological procedures, such as pap smears,
dilation and curettage (D&C) biopsy, and electrosurgery.
Contraindications
The illuminator (either by itself or in conjunction with a 590 series speculum) is
not intended to be used for eye examinations.
The illuminator (either by itself or in conjunction with a 590 series speculum) is
not intended to be used for diagnosis.
Classification
Class II, Type BF Applied Part Ordinary Equipment
Clean and disinfect as directed in Cleaning Section Non-continuous Operation
Symbol Descriptions
Warning Consult Directions for Use
Caution Lamp On
Caution, high temperatures Lamp Off
Caution, high intensity light Type BF Applied Part
Double Insulation Direct Current
IPX7
Illuminator is protected
against the effects of
temporary immersion in
water (and the solutions
described in this manual)
IPX0 Power supply - Not protected
from the ingress of water.
welchallyn.com
7d

1-2
Warnings and Cautions
WARNING: To avoid eye injury, do not look into the beam.
WARNING: Lamp is harmful to skin if touched. Allow lamp to cool for 5
minutes before replacing. Lamp generates heat and should remain off until
just prior to and immediately after use. Do not place illuminator onto a
flammable surface if lamp is illuminated.
WARNING: Disconnect power supply from outlet prior to any maintenance.
WARNING: This product is for use with the Welch Allyn KleenSpec Vaginal
Specula only. Do not use the illuminator for any other use. Lamp is hot and
can cause a burn if used outside of the vaginal specula.
WARNING: KleenSpec Corded Illumination System is not suitable for use in
the presence of a flammable anesthetic mixture with air or oxygen or nitrous
oxide. An explosion may result.
WARNING: The lamp is hot and can cause burns if used outside of the vaginal
specula.
CAUTION: Properly secure all cords and cables to minimize trip hazards.
CAUTION: Use only the cleaning methods and disinfection solutions/methods
described in this manual. Clean the device prior to disinfection.
CAUTION: The Illuminator is a biohazard after use. Follow good hospital
practices and the instructions for cleaning and disinfection of the illuminator
within this manual prior to the next usage.
CAUTION: Ensure lamp is installed and fully seated in illuminator throughout
cleaning and disinfection process. The illuminator assembly is immersible
(IPX7) provided the lamp is properly installed.
CAUTION: 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.
CAUTION: The illuminator cable is capable of temporary immersion to a depth
of 0.15 to 1 meter, at ambient pressure, at room and fluid temperatures of
22° C to 43° C. The power supply is not. Do not immerse the power supply.
U.S. Federal Law restricts this device to sale by or on the order of a physician.
To remove all power from the Welch Allyn KleenSpec Corded Illumination
System, unplug the external power supply from the wall outlet.
There are no user-serviceable parts inside the device except the lamp.
Contact Welch Allyn Technical Support: www.welchallyn.com/support.

1-3
Instructions for Use
KleenSpec Corded Illumination System
The KleenSpec Corded Illumination System is designed to work with the
following Welch Allyn specula: 58000S, 58001S, 58004S, 590XS, 59000, 59001,
59004, 59005, and 59006 for gynecological and obstetric procedures.
The power supply provides power from the hospital-grade wall outlet to the
illuminator assembly which houses the lamp. This provides illumination to the
specula. This device is intended for use only with Welch Allyn-appropriate
accessories.
This product is for use with the Welch Allyn KleenSpec Vaginal Specula only. Do
not use the illuminator for any other use. Lamp is hot and can cause a burn if used
outside of the vaginal specula.
The illuminator slides into the appropriate Welch Allyn KleenSpec Vaginal Specula
listed above. Verify all connections are made prior to applying power with the on/
off switch.
Power supply
Illuminator
On/Off switch

1-4
Inserting the Illuminator
Maintenance
Preventive Maintenance
Prior to use, examine cords, connections, and power supply case for wear or
damage.
After every use, clean the unit according to the Cleaning and Disinfection section
of this manual.
Model 580
series
Model 590 series
Sheath

1-5
Lamp Replacement
1. Disconnect the power supply from the wall outlet.
2. Allow lamp to cool for a minimum of 5 minutes and remove the lamp by
unscrewing counterclockwise (CCW).
3. Inspect the lamp socket of the illuminator for damage or irregularities.
Contact the authorized Service Center if any irregularities are found.
4. Replace with Welch Allyn REF 08800 lamp only.
5. Verify that the lamp o-ring is present and free from damage or debris prior to
installation. If o-ring is missing or damaged, replace the lamp.
6. Install by screwing clockwise (CW).
Note The lamp is the only user-serviceable part on the Illumination System.
Replace the lamp when there is insufficient illumination.
CW
CCW

1-6
Cleaning and Disinfecting
Cleaning
Wipe
KleenSpec Corded Illumination System
Refer to Cleaning Table to identify the appropriate cleaning product.
1. Disconnect the power supply from the wall outlet.
2. Follow the disinfecting wipe manufacturer’s instruction and wipe cord or
illuminator completely to remove any residue.
3. This process is a rough clean only. Refer to disinfection for further
processing.
Soak
Refer to Cleaning Table to identify the appropriate cleaning product.
KleenSpec Corded Illuminator
1. Disconnect the power supply from the wall outlet.
2. Follow the cleaning solution manufacturer’s instructions and soak the
illuminator as instructed. Solution temperature is 22° C to 43° C. Make sure
to keep the power supply out of the soak solution. Do not immerse the
power supply.
3. Scrub any area of visible debris with a soft brush and thoroughly rinse the
illuminator with 22° C to 43° C tap water to remove the cleaning solution. Do
not rinse the power supply; wipe only.
KleenSpec Corded
Illuminator Power supply
Cleaning
CaviWipe
(Wipe) Ye s Yes
Enzol (Soak) Yes No*
Metrizyme
(Soak) Yes No*
Disinfecting Caviwipe Intermediate Level Intermediate
Level
* Do not immerse the power supply plug. Follow instructions per this
manual.
CAUTION: Lamp must remain installed during all cleaning and
disinfecting processes.
CAUTION: Lamp must remain installed during all cleaning and
disinfecting processes.

1-7
4. Rough dry the illuminator.
5. The illuminator is now ready for disinfection.
Disinfecting
Refer to the Cleaning Table to identify the appropriate disinfection method/prod-
uct for the illuminator and power supply.
Illuminator
1. Clean or disinfect as described in the table above.
2. Follow the disinfecting wipe manufacturer’s disinfection instructions.
3. Thoroughly rinse illuminator with 22° C to 43° C tap water to remove
disinfectant.
4. Allow to dry.
Power supply
DO NOT IMMERSE THE POWER SUPPLY.
1. Clean or disinfect as described in the table above.
2. Follow the disinfecting wipe manufacturer’s disinfection instructions on the
cord only.
3. Thoroughly rinse the cord only with 22° C to 43° C tap water to remove
disinfectant. Do not immerse the power supply.
4. Allow to dry.
Disposal
There are no harmful materials associated with the KleenSpec Corded
Illumination System.
Device is considered a biohazard after use. Follow good hospital practices and
local ordinances in the disposal of the illuminator.
There are no risks associated with the disposal of this device after its useful life if
it is cleaned and/or disinfected per the instructions in this manual.

1-8
Specifications
Classification Class II, Type BF Applied Part
Input: 100V-240V, 50/60Hz
Output: 4.7 VDC, 850mA min
Category: Not AP/APG Equipment
Physical Specifications:
Illuminator system: 111 in (282 cm)
Illumination:
Lamp Life: 100 hours
Lamp Voltage: 4.6 V
Lamp: Welch Allyn part no. 08800
IPX Rating:
Illuminator: IPX7
Power supply: IPX0
Environment
Operating: +10° C to + 35° C (50° F to 95° F), 95% RH
500 hPa to 1060 hPa
Transport/Storage: -20° C to +49° C (-2° F to 120° F), 95% RH,
500 hPa to 1060 hPa
Intermittent Operation
Vag Spec and Illuminator 10 minutes on max; 5 minutes off min
Approvals
CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1
CONFORMS TO: IEC 60601-1, IEC60601-1-2

1-9
Troubleshooting Guide
Problem Possible Cause Solution
Lamp does not
light.
Power switch is in the off
position.
Verify the power switch is in the
on position. Refer to manual.
Illuminator is not plugged
in.
Verify that the illuminator is
properly plugged into the outlet.
Faulty lamp Replace with a new lamp.
Loose lamp Verify that the lamp is secured into
the illuminator.
Wrong lamp Verify that the lamp is a REF
08800 Welch Allyn lamp.
Damaged lamp
Inspect the lamp and the o-ring for
damage. Replace with REF 08800
lamp if damage is found.
Faulty illuminator system Replace the illuminator system.
No power from the
power supply outlet
Verify that power is supplied to the
illuminator outlet.
Illuminator does
not stay
retained into
580 series
specula or
78600
expendable
illuminator.
Possible damage to the
illuminator retention
wings.
Inspect retention wings for
damage. Replace illuminator
REF 789xx.
Light output
seems low.
Faulty Lamp Replace with a new lamp.
Dirty lamp lens Inspect lamp lens for debris and
clean.
This guide is intended to provide assistance towards determining the fault
condition of this product. Please contact the authorized Welch Allyn Service
Center listed within the product owners manual for additional assistance.

1-10
Warranty and Service
Limited 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 Welch Allyn KleenSpec Corded
Illumination System 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 must be notified via telephone of any defective product and the item
must be immediately returned, with an RMA number provided by Welch Allyn,
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 date of manufacture number defaced, (2) has
been repaired by anyone other than an authorized Welch Allyn Service
Representative, (3) has been altered, (4) has been used in a manner other than in
accordance with the instructions, or (5) has been abused or exposed to extreme
environmental conditions.
THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY IMPLIED WARRANTY
OR MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, OR OTHER
WARRANTY OF QUALITY, WHETHER EXPRESSED OR IMPLIED. WELCH ALLYN
WILL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM THE SALE, USE, OR IMPROPER FUNCTIONING OF THE
INSTRUMENTATION REGARDLESS OF THE CAUSE. THE DAMAGES FOR
WHICH WELCH ALLYN WILL BE RESPONSIBLE INCLUDE, BUT ARE NOT
LIMITED TO, LOSS OF REVENUE OR PROFIT, DOWNTIME COSTS, AND LOSS
OF USE OF THE INSTRUMENTATION.

1-11
Emissions and immunity information
Electromagnetic emissions
The Welch Allyn KleenSpec® Corded Illumination System is intended for use in
the electromagnetic environment specified below. The customer or the user of
the Welch Allyn KleenSpec® Corded Illumination System should assure that it
is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR11 Group 1
The KleenSpec® Corded Illumination
System 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 The KleenSpec® Corded Illumination System is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low voltage power
supply network that supplies buildings used
for domestic purposes.
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies

1-12
Electromagnetic immunity
The Welch Allyn KleenSpec® Corded Illumination System is intended for use in
the electromagnetic environment specified below. The customer or the user of
the Welch Allyn KleenSpec® Corded Illumination System should assure that it
is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for
power supply
lines
±1 kV for
input/output
lines
±2 kV for
power supply
lines
±1 kV for
input/output
lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV
differential
mode
± 2kV
common
mode
±1 kV
differential
mode
± 2kV
common
mode
Mains power quality should
be that of a typical
commercial or hospital
environment.

1-13
Voltage dips,
short
interruptionsand
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in
UT) for 0.5
cycle
40% UT
(60% dip in
UT) for 5
cycles
70% UT
(>95% dip in
UT) for 25
cycles
<5% UT
(>95% dip in
UT) for 5
seconds
<5% UT
(>95% dip in
UT) for 0.5
cycle
40% UT
(60% dip in
UT) for 5
cycles
70% UT
(>95% dip in
UT) for 25
cycles
<5% UT
(>95% dip in
UT) for 5
seconds
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the KleenSpec® Corded
Illumination System
requires continued
operation during power
mains interruptions, it is
recommended that the
device be powered from an
uninterruptible power
supply or a battery.
Power
frequency (50/
60Hz) magnetic
field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UTis the AC mains voltage prior to application of the test level.

1-14
Electromagnetic immunity
The Welch Allyn KleenSpec® Corded Illumination System is intended for use in
the electromagnetic environment specified below. The customer or the user of
the Welch Allyn KleenSpec® Corded Illumination System should assure that it
is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic
environment - guidance
Portable and mobile RF
communications
equipment should be used
no closer to any part of the
KleenSpec® Corded
Illumination System,
including cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the
transmitter.
Recommended
separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms d=(1.17)
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz
to 1 GHz 3 V/m d=(1.17) 80 to 800
MHz
P
P

1-15
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Welch Allyn KleenSpec® Corded Illumination System is used
exceeds the applicable RF compliance level above, the Welch Allyn KleenSpec® Corded
Illumination System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Welch Allyn
KleenSpec® Corded Illumination System.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d= (2.33) 800 MHz to
2.5 GHz where Pis the
maximum output power
rating of the transmitter in
watts (W) and dis the
recommended separation
distance in meters (m).
Field strengths from fixed
RF transmitters, as
determined by an
electromagnetic site
surveya, should be less
than the compliance level
in each frequency rangeb.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
P

1-16
For transmitters rated at a maximum output power not listed above, the recommended separation
distanced in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter 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: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Recommended separation distances between portable and mobile
RF communications equipment and the Welch Allyn KleenSpec®
Corded Illumination System
The Welch Allyn KleenSpec® Corded Illumination System is intended for use in
an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user of the Welch Allyn KleenSpec® Corded
Illumination System can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Welch Allyn KleenSpec®
Corded Illumination System as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated max.
output power
of transmitter
(W)
150 kHz to 80
MHz
d=(1.17)
80 MHz to
800 MHz
d=(1.17)
800 MHz to 2.5 GHz
d=(2.23)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11. 17 1. 17 2.33
10 3.70 3.70 7. 3 7
100 11.67 11.67 23.33
P
P
P