KleenSpec 800 Series Instructions for Use Ver B March 2020

© 2020 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. PATENT/PATENTS For patent information, visit hillrom.com/patents. May be covered by one or more patents. See above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications. For information about any Hill Rom product, contact your local Hill Rom representative: hillrom.com/en-us/about-us/locations. Notice to Users and/or Patients in EU: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

DIR 80025951 Ver. B

This manual applies to

901070 VAGINAL SPECULUM LIGHTING SYSTEM.

Revised 2020-03

and EU Importer

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA Welch Allyn Inc. is a subsidiary of Hill- Rom Holdings, Inc. hillrom.com

Welch Allyn Limited Navan Business Park Dublin Road Navan, Co Meath C15 AW22 Ireland

Authorized Australian Sponsor Welch Allyn Australia Pty. Ltd. Unit 4.01, 2-4 Lyonpark Road Macquarie Park, NSW 2113 Phone 1800 650 083

1

English Introduction Intended use When used with the KleenSpec® Disposable Vaginal Speculum (vaginal speculum), 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. The intended users of the device are clinicians who are qualified to perform a pelvic examination. The intended environment is any location where a pelvic examination is conducted (hospital, clinic, office, long term care facility, etc.). The intended patients are all female patients who are eligible for a pelvic examination and who the clinician determines will fit with the size specula that are available (extra small, small, medium, large).

Contraindications The illuminator (either by itself or in conjunction with a KleenSpec vaginal speculum) is not intended to be used for eye examinations or to provide a diagnosis.

Symbols The symbols illustrated on the following pages may appear in this Instructions for use or on the 800 Series Cordless Illuminator (illuminator) or charging station. For information on the origin of these symbols, visit http://www.welchallyn.com/symbolsglossary for the Welch Allyn symbols glossary. Symbol

Description WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document.

Symbol

Description Keep dry

2

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Symbol

Description

Symbol

Description

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.

Non-ionizing electromagnetic radiation

Global Trade Item Number

Consult instructions for Use

For use by or on the order of a licensed medical professional

This way up

Manufacturer

Fragile

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

Temperature limit

Product identifier

Humidity limitation

Reorder number

Recyclable

Authorized Representative in the European Community

Medical device

Lot code

Rechargeable battery Li-ion

Approved for use in Japan

Type BF applied part when used with the KleenSpec Disposable Vaginal Speculum

Instructions for use

English

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 Hill-Rom Technical Support: hillrom.com/enus/about-us/locations to 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. WARNING Inspect illuminator prior to use. Do not use if damaged. WARNING To avoid eye discomfort, do not look into the beam. WARNING Use only the cleaning methods and disinfection solutions described in this manual. Clean the device prior to disinfection. WARNING 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 Disconnect the AC power cord from the charger to the mains outlet to remove power to the device. 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. CAUTION Check low battery indicator for battery charge. Ensure battery is in good condition, (not bulging or cracking before charging.

4

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Residual Risk This product complies with relevant electro-magnetic interference, mechanical safety, performance, and biocompatibility standards. However, the product cannot completely eliminate potential patient or user harm from the following: • Harm or device damage associated with electro-magnetic hazards, • Harm from mechanical hazards, • Harm from device, function, or parameter unavailability, • Harm from misuse error, such as inadequate cleaning, and/or • Harm from device exposure to biological triggers that may result in a severe systemic allergic reaction.

Use and maintain the illuminator Charge the illuminator Charge the illuminator before using it the first time. 4-5 hr

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

Description

Off

No AC power

Green

AC power / Full charge

Amber

Illuminator inserted into charging base and is charging

Instructions for use

English

5

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.

2.

Clean the illuminator. a.

Following the wipe manufacturer's instructions, wipe the entire illuminator to remove any visible debris.

b.

Discard used wipe appropriately.

Disinfect the illuminator (intermediate level). a.

Follow wipe label instructions for appropriate contact times.

b.

Discard used wipe appropriately.

Clean the charging base 1.

Unplug the power cord.

2.

Use an approved wipe to remove visible debris.

3.

Discard used wipe appropriately.

6

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

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 Hill Rom-approved part. For ordering information, contact your local Hill Rom representative: hillrom.com/en-us/about-us/locations

Disposal Disposal must be in accordance with the following steps: 1.

Follow the cleaning and disinfection instructions presented in this instructions for use.

2.

Segregate material in preparation for the recycling process.

3.

Disassemble and recycle components based on the type of material: •

Plastic to be recycled as plastic waste

•

Metal to be recycled as metal ○

Includes loose components containing more than 90% metal by weight

○

Includes screws and fasteners

•

Electronic components, including the power cord, to be disassembled and recycled as Waste of Electrical and Electronic Equipment (WEEE)

•

Batteries to be dismantled from the device and recycled as per WEEE

Users must adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hillrom Technical Support for guidance on safe disposal protocols.

Appendices Appendix A: Specifications Charging station power supply classification: US, Canada, & International; Class I and internally powered Characteristic Input

Specification 100-240v / 50-60Hz 160-80 mA

Output

5v DC 1400 mA

Category

Not AP/APG Equipment

Instructions for use

English

7

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

Capacity 400mAh Voltage 3.7 V Chemistry Li-Ion Polymer Rechargeable Li-Ion Polymer Battery Charge time 4 hours On-Time use 80 minutes

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

8

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Safety, EMC and regulatory compliance CISPR 11/EN 55011/AS_NZS CISPR 11, RF Emissions CISPR 11, Conducted Emissions

Lot Code Lot: YYYY/MM/DD YYYY=Year of manufacture MM=Month of manufacture DD=Day of manufacture

Instructions for use

English

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 Available only with the 74010, 74015, 80010, and 80015 Charging Stations

1899414

International Power Supply Adaptor Kit NOTE Available only with the 74015 and 80015 Charging Stations.

NOTE USB Cable is not sold separately.

4-5 hr

9

10

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Appendix C: Compatible devices KleenSpec Vaginal Specula-Premium 590 Series 590XS KleenSpec 590 Series Premium Disposable Vaginal Specula, X-Small 59000 KleenSpec 590 Series Premium Disposable Vaginal Specula, Small 59001 KleenSpec 590 Series Premium Disposable Vaginal Specula, Medium 59004 KleenSpec 590 Series Premium Disposable Vaginal Specula, Large KleenSpec Vaginal Specula-Premium 590 Series with Smoke Tube 59005 KleenSpec 590 Series Premium Disposable Vaginal Specula with Smoke Tube, Small 59006 KleenSpec 590 Series Premium Disposable Vaginal Specula with Smoke Tube, Medium

Instructions for use

English

11

Appendix D: 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 Instructions 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 Hill Rom for use with the 800 Series. Accessories not recommended by Hill Rom 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

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.

CISPR 11 RF emissions

Class B

CISPR 11 Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ Complies flicker emissions

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 purposes.

12

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Electromagnetic emissions IEC 61000-3-3

WARNING This equipment/system is intended for use by healthcare professionals only. This 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)

±8 kV contact

±8 kV

±15 kV air

±15 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

±2 kV for power supply lines

±2 kV

±1 kV for input/ output lines

±1 kV

±0.5 kV, ±1 kV

±1 kV

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Line- to -line

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.

±0.5 kV, ±1 kV, ±2 kV ±2 kV Line-to-ground Voltage dips, short 0 % UT; 0.5 cycle 0 % UT; 0.5 cycle interruptions and voltage variations on power supply input At 0°, 45°, 90°, 135°, lines 180°, 225°, 270° and IEC 61000-4-11 315° 0 % UT; 1 cycle

0 % UT; 1 cycle

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.

Instructions for use

English

13

Electromagnetic immunity 70 % UT; 25/30 cycles 70 % UT; 25/30 cycles Single phase: at 0° 0 % UT; 250/300 cycle

0 %UT; 250/300 cycle

Power frequency 30 A/m (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

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

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz

3 Vrms

6Vrms in ISM and 6Vrms . amateur radio bands between 150 kHz and 80 MHz. Radiated RF IEC 61000-4-3

10 V/M, 80 MHz to 2.7 GHz

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

14

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Electromagnetic immunity 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. 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 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.

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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) 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz Rated max. output outside ISM bands in ISM bands power of transmitter (W)

800 MHz to 2.7 GHz

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.

Instructions for use

English

15

Recommended separation distances between portable and mobile RF communications equipment and the 800 Series 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)

MHz

385

380 - 390

Band a

Service a

Modulation b

Maximum power (W)

Distance (m) Immunity test level (V/ m)

TETRA 400

Pulse modulation b

1.8

0.3

27

2

0.3

28

0.2

0.3

9

2

0.3

28

2

0.3

28

2

0.3

28

0.2

0.3

9

18 Hz 450

430 - 470

GMRS 460, FRS 460

FM c±5 kHz deviation 1 kHz sine

710

704 - 787

LTE band 13, 17

745

Pulse modulation b 217 Hz

780 810

800 - 960

870 930 1720

LTE Band 5 1700 - 1990

1845 1970 2450

GSM 800/900, Pulse TETRA 800, modulation b iDEN 820, 18 Hz CDMA 850,

2400 - 2570

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation b 217 Hz

Bluetooth, Pulse WLAN, 802.11 modulation b b/g/n, RFID 217 Hz 2450, LTE Band 7

5240 5500

5100 - 5800

WLAN 802.11 Pulse a/n modulation b 217 Hz

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.

16

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System

Test specifications for enclosure port immunity to RF wireless communications equipment 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.

Instructions for use

English

17

Appendix E: Limited warranty Hill Rom 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 Hill Rom 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 Hill Rom, 2) the date specified during product registration, 3) the date of purchase of the product from a Hill Rom 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 instructions for use provided with individual accessories for warranty information. Shipping cost to return a device to a Hill Rom Service center is not included. A service notification number must be obtained from Hill Rom prior to returning any products or accessories to Hill Rom’s designated service centers for repair. To obtain a service notification number, contact Hill Rom Technical Support at hillrom.com/en-us/about-us/locations. 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.

18

English

Welch Allyn® KleenSpec 800 Series Cordless Illumination System