Page 1
®
Welch Allyn
KleenSpec 800 Series
Cordless Illumination System
Directions for use
Page 2
© 2018 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, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact your local Welch Allyn representative: www.welchallyn.com/
about/company/locations.htm.
DIR 80021345 Ver. C
Revised 2018-07
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallyn.com
This manual applies to 901070 VAGINAL SPECULUM LIGHTING SYSTEM.
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland
Page 3
Contents
Introduction ............................................................................................. 1
Use and maintain the illuminator .......................................................... 5
iii
Intended use ........................................................................................................ 1
Contraindications ................................................................................................. 1
Symbols ............................................................................................................... 1
Warnings and cautions ......................................................................................... 3
Charge the illuminator .......................................................................................... 5
Use the illuminator for a pelvic examination ........................................................ 6
Clean and disinfect ............................................................................................... 6
Inspect the system .............................................................................................. 7
Appendices .............................................................................................. 9
Appendix A: Specifications .................................................................................. 9
Appendix B: Accessories ................................................................................... 11
Appendix C: EMC guidance and manufacturer’s declarations ........................... 12
Appendix D: Limited warranty ........................................................................... 18
Page 4
iv Contents Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Page 5
Introduction
Intended use
When used with the KleenSpec
Welch Allyn®KleenSpec 800 Series Cordless Illumination System (the illuminator)
provides illumination during pelvic examinations and other gynecological procedures,
such as pap smears, dilation and curettage (D&C) biopsy, and electrosurgery.
®
Disposable Vaginal Speculum (vaginal speculum),
1
Contraindications
The illuminator (either by itself or in conjunction with a KleenSpec® vaginal speculum) is
not intended to be used for eye examinations.
The illuminator (either by itself or in conjunction with a KleenSpec vaginal speculum) is
not intended to be used for diagnosis.
Symbols
The symbols illustrated on the following pages may appear in this Directions for use or
on the 800 Series Cordless Illuminator (illuminator) or charging station.
Symbol
Description Symbol Description
WARNING The warning
statements in this manual
identify conditions or practices
that could lead to illness, injury,
or death.
In a black and white document,
this symbol appears with a grey
background.
CAUTION The caution
statements in this manual
identify conditions or practices
that could result in damage to
the equipment or other property,
or loss of data.
Keep dry
Non-ionizing electromagnetic
radiation
Global Trade Item Number Consult Directions for use
Page 6
2 Introduction Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Symbol Description Symbol Description
For use by or on the order of a
licensed medical professional
Manufacturer Fragile
Separate collection of Electrical
and Electronic Equipment. Do not
dispose as unsorted municipal
waste.
Reorder number Humidity limitation
Product Identifier Recyclable
Authorized Representative in the
European Community
This way up
Temperature limit
Meets essential requirements of
the European Medical Device
Directive 93/42/EC
Lot code
Li-ion
Approved for use in Japan Type BF applied part when used
Rechargeable battery
with the KleenSpec Disposal
Vaginal Speculum
Page 7
Directions for use Introduction 3
Warnings and cautions
WARNING Patient injury risk. No modifications to the illuminator is
allowed. Modification of the illuminator could be hazardous to patients and
personnel.
WARNING Patient injury risk. This device comes with a power supply and/
or power cord that is intended for use only with this device. The power
supply or power cord have not been tested and approved for use with
other devices that may have the same power connectors. If you cannot
locate the original power supply and/or power cord, contact Welch Allyn
Technical Support:
obtain replacement parts.
WARNING Patient injury risk. KleenSpec Cordless Illumination System is
not suitable for use in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide. An explosion may result.
CAUTION Disconnect the AC power cord from the charger to the mains
outlet to remove power to the device.
www.welchallyn.com/about/company/locations.htm to
CAUTION The charging station and power cord are not protected from the
ingress of liquid.
CAUTION Do not position any part of the illumination system in any way
that makes it difficult to disconnect AC power from the device. To remove
all AC power from the illumination system, unplug the external power
supply from the mains outlet.
Page 8
4 Introduction Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Page 9
Use and maintain the illuminator
4-5 hr
Charge the illuminator
Charge the illuminator before using it the first time.
5
1. Connect the charging base to AC power.
2. Place the illuminator (either direction) into the charging station.
3. Remove the charged illuminator when you are ready to use it.
Full charging takes 4 to 5 hours.
Note It is safe to leave the illuminator in the charging station after it is charged.
The charging base has the following status indicators.
Status
Off No AC power
Green AC power / Full charge
Amber Illuminator inserted into charging base and is charging
Description
Page 10
6 Use and maintain the illuminator Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Use the illuminator for a pelvic examination
1. Fully insert the illuminator into a KleenSpec Disposable Vaginal Speculum (in either
direction).
2. Press the power button on the illuminator.
3. Complete the examination.
4. When the examination is completed, remove the speculum and press the power
button to turn off the illuminator.
5. Remove the illuminator from the speculum.
Clean and disinfect
The following are approved wipes for cleaning and disinfecting.
•
CaviWipes
•
Super Sani-Cloth
• 70% isopropyl alcohol
Clean and disinfect the illuminator
Following are directions for cleaning and intermediate disinfecting of the illuminator.
1.
Clean the illuminator.
a. Following the wipe manufacturer's instructions, wipe the entire illuminator to
b. Discard used wipe appropriately.
2. Disinfect the illuminator (intermediate level).
a. Follow wipe label instructions for appropriate contact times.
b. Discard used wipe appropriately.
Clean the charging base
®
®
remove any visible debris.
1. Unplug the power cord.
2. Use an approved wipe to remove visible debris.
3. Discard used wipe appropriately.
Page 11
Directions for use Use and maintain the illuminator 7
Inspect the system
1. Examine all components of the cordless illumination system regularly. Components
include the illuminator and charging base.
2. If any component is worn or damaged, replace it with a Welch Allyn-approved part.
For ordering information, contact your local Welch Allyn representative:
www.welchallyn.com/about/company/locations.htm
Page 12
8 Use and maintain the illuminator Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Page 13
Appendices
Appendix A: Specifications
Charging station power supply classification: US, Canada, & International; Class I and internally
powered
Characteristic Specification
9
Input
Output
Category Not AP/APG Equipment
Physical specifications
Characteristic Specification
Illuminator 1.96 W x 1.37 D x 3.74 H in; 50 W x 35 D X 95 H mm
Charger 3.14 x 4.33 x 2.55-4.60 in; 80 W x 110 D X 65-117 H mm
Power supply 1.24 W x 2.16 L x 1.61 D in; 31.5 W x 55 L x 41 D mm
LED radiation output <6.67mW at 400-750 wavelengths
Battery cell
100-240v / 50-60Hz
160-80 mA
5v DC
1400 mA
Capacity 400mAh
Voltage 3.7 V
Chemistry Li-Ion Polymer
Rechargeable Li-Ion Polymer
Battery Charge time 4 hours
On-Time use 80 minutes
Page 14
10 Appendices Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Environment (temperature and humidity)
Characteristic Specification
Operating +10°C (50°F) and +35°C (95°F)
700 hPa - 1060 hPa
30% - 75% non-condensing
Transport/Storage –20°C (-4°F) and +49°C (120°F)
500 hPa - 1060 hPa
15% - 95% non-condensing
Operation
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and
other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
Safety, EMC and regulatory compliance
UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment, Part 1: General Requirements for Safety
IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety, and associated CB Scheme Report
and Certificate.
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
EN 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
CISPR 11/EN 55011/AS_NZS CISPR 11, RF Emissions
CISPR 11, Conducted Emissions
Page 15
4-5 hr
Directions for use Appendices 11
Appendix B: Accessories
Part number Description Illustration
80000 KleenSpec Vaginal Speculum Cordless
Illuminator
80010 KleenSpec Vaginal Speculum Cordless
Illuminator with Charging Station/Domestic
80015 KleenSpec Vaginal Speculum Cordless
Illuminator with Charging Station/
International
74010 KleenSpec Charging Station/Domestic
74015 KleenSpec Charging Station/International
FW8002MUSB/05 Power Supply
Note
1899414 International Power Supply Adaptor Kit
Note
Available only with the
74010, 74015, 80010, and
80015 Charging Stations
Available only with the
74015 and 80015 Charging
Stations.
Note
USB Cable is not sold separately.
Page 16
12 Appendices Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Appendix C: EMC guidance and manufacturer’s declarations
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC 60601-1-2:2014/EN
60601-2-1:2015.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The device complies with all applicable and required standards for electromagnetic
interference.
• It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
• It is not safe to operate the device in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using the device in extremely close proximity to
other equipment.
WARNING The use of the 800 Series adjacent to or stacked with other
equipment or medical electrical systems should be avoided because it
could result in improper operation. If such use is necessary, the 800 Series
and other equipment should be observed to verify that they are operating
normally.
WARNING Use only Accessories recommended by Welch Allyn for use
with the 800 Series. Accessories not recommended by Welch Allyn may
affect the EMC emissions or immunity.
WARNING Maintain minimum separation distance between the 800
Series and portable RF communication equipment. Performance of the 800
Series may be degraded if proper distance is not maintained.
Emissions and immunity information
Electromagnetic emissions
The Welch Allyn KleenSpec 800 Series is intended for use in the electromagnetic environment specified below. The
customer or user of the 800 Series should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The 800 Series 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.
Page 17
Directions for use Appendices 13
Electromagnetic emissions
RF emissions
CISPR 11
Class B
The 800 Series 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
Harmonic emissions
IEC 61000-3-2
Class A
purposes.
WARNING This equipment/system is intended for
use by healthcare professionals only. This
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment a. It
may be necessary to take mitigation measures, such
as re-orienting or relocating the 800 Series or
shielding the location.
a
The 800 Series contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency hopping
spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according to the
requirements of various agencies, including FCC 47 CFR 15.247 and Radio Equipment Directive 2014/53/EU. The
transmitter is excluded from the EMC requirements of 60601-1-2, but should be considered when addressing possible
interference issues between this and other devices.
Electromagnetic immunity
The 800 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the
800 Series 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
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
±8 kV contact
±15 kV air
±2 kV for power supply
±8 kV
±15 kV
±2 kV Mains power quality should be that of a typical
lines
±1 kV for input/output
±1 kV
lines
±0.5 kV, ±1 kV
±1 kV
Line- to -line
±0.5 kV, ±1 kV, ±2 kV
±2 kV
Line-to-ground
0 % UT; 0.5 cycle 0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0 % UT; 1 cycle 0 % UT; 1 cycle
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the 800 Series requires continued operation
during power mains interruptions, it is
recommended that the 800 Series be be
powered from an uninterruptible power supply
or a battery.
Page 18
14 Appendices Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Electromagnetic immunity
70 % UT; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 cycle 0 %UT; 250/300 cycle
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
30 A/m 30 A/m Power frequency magnetic fields should be at
70 % UT; 25/30 cycles
levels characteristic of a typical location in a
typical commercial or hospital environment.
Page 19
Directions for use Appendices 15
Electromagnetic immunity
The 800 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the
800 Series 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 800 Series, 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
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6Vrms in ISM and
amateur radio bands
between 150 kHz and
80 MHz.
10 V/M, 80 MHz to 2.7
GHz
3 Vrms
6Vrms .
10 V/M
800 MHz to 2.7 GHz
80 MHz to 800 MHz
where P is the maximum output power rating of
the transmitter in watts (W) and d is 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:
Note1: 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.
a
Field 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 800 Series is used exceeds the applicable RF
compliance level above, the 800 Series should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the 800 Series.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Page 20
16 Appendices Welch Allyn®KleenSpec 800 Series Cordless Illumination System
Recommended separation distances between portable and mobile RF communications
equipment and the 800 Series
The 800 Series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or user of the 800 Series can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the 800 Series 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
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80 MHz in
ISM bands
80 MHz to 800 MHz 800 MHz to 2.7 GHz
(W)
0.01 0.12 0.20 0.12 0.23
0.1 0.37 0.63 0.38 0.73
1 1.17 2.00 1.20 2.30
10 3.69 6.32 3.79 7.27
100 11.67 20.00 12.00 23.00
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.
Test specifications for enclosure port immunity to RF wireless communications equipment
Test frequency
(MHz)
Band
MHz
a
Service
a
385 380 - 390 TETRA 400
450 430 - 470 GMRS 460,
FRS 460
710 704 - 787 LTE band 13, 17
745
780
810 800 - 960 GSM 800/900,
TETRA 800,
870
Modulation
b
Pulse modulation
18 Hz
FM c±5 kHz
deviation
1 kHz sine
Pulse modulation
217 Hz
Pulse modulation
18 Hz
Maximum power
Distance (m) Immunity
(W)
b
1.8 0.3 27
2 0.3 28
b
0.2 0.3 9
b
2 0.3 28
test level (V/
m)
Page 21
Directions for use Appendices 17
Test specifications for enclosure port immunity to RF wireless communications equipment
930
iDEN 820,
CDMA 850,
LTE Band 5
1720 1700 - 1990 GSM 1800;
CDMA 1900;
1845
1970
GSM 1900;
DECT; LTE Band
1, 3, 4, 25;
UMTS
2450 2400 - 2570 Bluetooth,
WLAN, 802.11
b/g/n, RFID
Pulse modulation
217 Hz
Pulse modulation
217 Hz
b
2 0.3 28
b
2 0.3 28
2450,
LTE Band 7
5240 5100 - 5800 WLAN 802.11
a/n
Pulse modulation
217 Hz
b
0.2 0.3 9
5500
5785
a
For some services, only the uplink frequencies are included.
b
The carrier shall be modulated using a 50 percent duty cycle square wave signal.
c
As an alternative to FM modulation, 50 percent pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case.
Page 22
Appendices Welch Allyn®KleenSpec 800 Series Cordless Illumination System
18
Appendix D: Limited warranty
Welch Allyn warrants the product to be free of defects in material and workmanship and
to perform in accordance with manufacturer's specifications for the period of one year
from the date of purchase from Welch Allyn or its authorized distributors or agents.
The warranty period shall start on the date of purchase. The date of purchase is: 1) the
invoiced ship date if the device was purchased directly from Welch Allyn, 2) the date
specified during product registration, 3) the date of purchase of the product from a
Welch Allyn authorized distributor as documented from a receipt from said distributor.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.
The product warranty is also subject to the following terms and limitations: Accessories
are not covered by the warranty. Refer to the directions for use provided with individual
accessories for warranty information.
Shipping cost to return a device to a Welch Allyn Service center is not included.
A service notification number must be obtained from Welch Allyn prior to returning any
products or accessories to Welch Allyn's designated service centers for repair. To obtain
a service notification number, contact Welch Allyn Technical Support at
www.welchallyn.com/about/company/locations.htm.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT
OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT
DEFECT COVERED BY THE WARRANTY.
Page 23
Loading...