Declaration of Conformity - Masterpiece · Welch Allyn, Inc. declares under its sole responsibility...

Declaration of ConformityNumber : DOCE009

Manufacturer: Welch Allyn, Inc.

Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 U.S.A.

Representative: European regulatory Manager, Welch Allyn Ltd.

Address: Kells Road, Navan, County Meath, Republic of Ireland. Tel. +353 46 79075 Fax.+353 46 27128

Welch Allyn, Inc. declares under its sole responsibility that the product,

Model Number: 78103, 78105, 78114, and 78115

Name: Vaginal Speculum Illumination System

to which this declaration relates is in conformity with the following standards

EN 60601-1-2 : 1993, Medical electrical equipment, Part 1. General requirements for safety, Section 1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests.

Following the provisions of European Council Directive 89/336/EEC. On the approximation of laws of Member States relating to electromagnetic compatibility.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: May 12, 1999



Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220U.S.A.

Representative: European regulatory Manager,Welch Allyn Ltd.

Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128


Model Number: 791100

Name: Power Supply


EN 60601-1-2 : 1993, Medical electrical equipment, Part 1. General requirements forsafety, Section 1.2 Collateral standard: Electromagnetic compatibility - Requirements andtests.

Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility.

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: December 22, 1995







Model Number: 96100, 96102, 96104, 96150, 96152, and 96154

Name: PneumoCheck Spirometer





Rev. 12/95






Welch Allyn, Inc. declares under its sole responsibility that the Product

Model Number: LCI-100CE

Name: Video imaging system





Rev. 1/96




Representative: European Regulatory Manager,Welch Allyn Ltd.



Model Number: LCI-200CE, CIS-200CE, 83-1339

Name: Video Imaging System


EN 60601-1-2, Medical electrical equipment, Part 1. General requirements for safety,Section 1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests.


Quality Assurance Manager Signed: Welch Allyn, Inc. Date: January 4, 1996


Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,

Skaneateles Falls, NY 13153-0220USA

Manufacturing site: Welch Allyn LtdAddress: Kells Road, Navan, Meath, Republic of Ireland




Model Number: 44100, 44102, 44104, 44112, 44114

Name: LS100 Exam Light


EN 55015:1993 Limits and methods of measurement of radio disturbance characteristicsof electrical lighting and similar equipment.

EN 60601-1 Medical electrical equipment Pat 1: General requirements for safety.

Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility and theprovisions of European Council Directive 73/23/EEC relating to electrical equipmentdesigned for use within certain voltage limits.

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 7, 99







Model Number: 44200, 44202, 44204

Name: LS 200 Exam Light


EN 55015 Limits and methods of measurement of radio disturbance characteristics ofelectrical lighting and similar equipment.


Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility andthe provisions of European Council Directive 73/23/EEC Relating to electricalequipment designed for use within certain voltage limits.


Declaration of ConformityNumber : DOCM032


Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA

Representative: European Regulatory Manager, Welch Allyn Ltd.



Model Number: 49032, 49034, 49036, 49020, 49022, 49024, 49026, 49500, 49500TW, and 49540

Name: Headlights


EN 60601-1, EN 60601-1-2, EN 980, and EN 1041.

The quality system that controls the manufacture and design of this product complies with the following standards, EN ISO 9002:1994 and EN 46002:1993.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class I under rule(s) 1 & 10 of Annex IX of this directive.

Sr. Regulatory Affairs Manager Signed : Welch Allyn, Inc. Date: March 17, 2004







Model Number: 46022, 46023, 46050, 46070, 46072, 46074, and 46076

Name: Direct Focusing and Solid State Portable Headlight


EN 60601-1, EN 60601-1-2, EN 980, EN 1041.



SR. Regulatory Affairs Manager Signed : Welch Allyn, Inc. Date: September 29, 2003







Model Number: HLS24-2, HLS24-4, HLS24-6.

Name: Industrial Light Source


EN 50081-1 EMC Generic Emission Standard Part 1. Residential, Commercial and LightIndustry.

EN 50082-1 EMC Generic Immunity Standard Part 1. Residential, Commercial and LightIndustry.


Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility and theprovisions of European Council Directive 73/23/EEC Relating to electrical equipmentdesigned for use within certain voltage limits.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: September 4, 1997


Manufacturer: Welch Allyn inc.Address: 4341 State Street Road,

Skaneateles Falls, NY 13153-0220U.S.A.

Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Road

Skaneateles Falls, NY.13153-0220




Model Number: XL240LSA, XL810A PAL, XL815A PAL, XL820A PAL, XL830A PAL, XL845A PAL,XL860A PAL, XL875A PAL, XL610A PAL, XL615A PAL, XL620A PAL, XL630APAL, XL645A PAL, XL660A PAL, XL675A PAL, XL810A, XL815A, XL820, XL830A,XL845A, XL860A, XL875A. XL610A, XL615A, XL620A, XL630A, XL645A, XL660A,XL675A, XL600A, XL800A, XL600 PAL, XL800A PAL.

Name: Video Probe


EN 50081-2: Electromagnetic compatibility - Generic emission standard part 2. Industrial environment.

EN 50082-2 Electromagnetic compatibility - Generic immunity standard part 2. Industrialenvironment.




Manufacturer: Welch Allyn inc.Address: 4341 State Street Road,


Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Rd,

Skaneateles falls, NY. 13153-0220




Model Number: XLAMS-LSA, XLAMS-LSA-P

Name: Measurement system for Video Probe XL.


EN 50081-2: Electromagnetic compatibility - Generic emission standard part 2. Industrial environment.





Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,


Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Road,

Skaneateles Falls, NY.

Representative: European Regulatory Manager,Welch Allyn Ltd.Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 70705Fax. +353 46 27128


Model Number: VP 3 System, consisting of VS100, VS200, VS300, VP 115S, VP115-AMS, VP 116, VP116S, VP116-AMS, VA280, VK107, VP117S, VP117S-AMS, VP 118S, VP 118-AMS.

Name: Video Probe 2000


EN 50081-1 Electromagnetic compatibility - Generic emission standard part 2. Industrialenvironment.


Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility andfollowing the provisions of European Council Directive 73/23/EEC relating to electricalequipment designed for use within certain voltage limits.





Manufacturing site: Diatek InstrumentsAddress: 7420 Carroll Road,

San Diego, CA 92121-2334.U.S.A.


Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128


Model Number: 20812-XXX

Name: Model 9600 Calibration Tester.


EN 55011, Limits and methods of measurement of radio distrubance characteristics ofIndustrial, Scientific and medical equipment

EN 50082-1, Electromagnetic Compatibility- Generic Immunity Standard Part 1.Residential, commercial and light industry.


Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: September 4, 1996





Adress: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128


Model Number: 46120, 46120TW, 46122, 46124, 46126, 47100, 47102, 47104,47106, 47120, 47122, 47124, 47126, 49520, 49520TW, 49522,49522TW, 49524, 49524TW, 49526, 49526TW, 49600, 49602,49604, 49606, 49620, 49622, 49624, 49626

Name: Fibre optic headlight illumination system.

EN 60601-1, and EN 60601-1-2,

Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility, andof European Council Directive 73/23/EEC relating to electrical equipment designed foruse within certain voltage limits.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: October 9, 1997




Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Road, Skaneateles Falls, NY.

Representative: European Regulatory Manager,Welch Allyn Ltd.Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 28122Fax. +353 46 28536


Model Number: CIS-200CES, CIS-200S.

Name: Video Processor


EN 50081-1 Electromagnetic compatibility - Generic emission standard part 2. Industrialenvironment.


Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility andfollowing the provisions of European Council Directive 73/23/EEC relating to electricalequipment designed for use within certain voltage limits.


Declaration of ConformityNumber : DOC063

Sub Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,


Manufacturing site: Welch Allyn Inc.Address: Skaneateles Falls, NY. USA.

Representative: European Regulatory Manager,Welch Allyn Ltd.Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79060Fax.+353 46 27128


Model Number: 502220175, 502220177.

Name: Stryker, Quantum 2000 Light Source

Manufactured and labelled under contract between Welch Allyn and STRYKERFRANCE, ZAC Paris Nord II, 13 rue de la Perdrix, 932090 Tremblay en France.

And to which this declaration relates is in conformity with the following standards

EN 60601-1:1990, EN 60601-1-2:1993, EN 1441, EN 980, and EN 1041.

The quality system that controls the manufacture and design of this product complieswith the following standards, EN ISO 9001:1994 and EN 46001:1993.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rule(s) 1 & 12. of Annex IX of thisdirective.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: October 15, 1997



Skaneateles Falls, NY 13153-0220

Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Road,

Skaneateles Falls, NY. 13153-0220




Model Number: LS100, LS240, LS6000, LS6000 P, LS6120, LS6120 P, LS6180, LS10120,LS10120 P, LS10180, LS10180 P, LS10000, LS10000P, LS10300, LS10300 P, XL6xxB, XL6xxB PAL,XL8xxB, XL8xxB PAL, XL240LSB, XLAMS-LSB, XLAMS-LSB-P, XLBA1, XLBA1 PAL, XLF6xxB, XLF6xxBPAL, XLM6xxB, XLM6xxB PAL, XLF8xxB, XLF8xxB PAL, XLM8xxB, XLM8xxB PAL

Note: xx = length in Meters

Name: Video Probe

to which this declaration relates is in conformity with the following standards:

EN 50081-2: Electromagnetic compatibility - Generic emission standard part 1. Industrial environment.EN 50082-2 Electromagnetic compatibility - Generic immunity standard part 2. Industrialenvironment.EN 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, andLaboratory Use


Quality Assurance Manager Signed:Welch Allyn, Inc. Date: November 6, 1998

Declaration of ConformityDOCE093





Welch Allyn, Inc., declares under its sole responsibility that the product,

Model Number: XLM675C PAL, XLM660C PAL, XLM645C PAL, XLM630C PAL,XLM625C PAL, XLM620C PAL, XLM615C PAL, XLM610C PAL, XLM675C, XLM660C,XLM645C, XLM630C, XLM625C, XLM620C, XLM615C, XLM610C, XLF675C PAL,XLF660C PAL, XLF645C, XLF630C PAL, XLF625C PAL, XLF620C PAL,XLF615C PAL, XLF610C PAL, XLF675C, XLF660C, XLF645C, XLF630C, XLF625C,XLF620C, XLF615C, XLF610C, XL675C PAL, XL660C PAL, XL645C PAL,XL630C PAL, XL625C PAL, XL620C PAL, XL615C PAL, XL610C PAL, XL675C,XL660C, XL645C, XL630C, XL625C, XL620C, XL615C, XL610C

Name: Video Probe

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directives 89/336/EEC (Electromagnetic Compatibility) and 73/23/EEC (LowVoltage) concerning medical devices and with the following standards:

EN 60601-1, EN 60601-1-2, EN 50081-1, and EN 55011

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: September 30, 1999







Model Number: 23100V, 23101V, 23102V, 23104V, and 23106V

Name: VideoPath Vet Imaging

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directives 84/539/EEC (Electro-medical Equipment in Veterinary Medicine),73/23/EEC (Low Voltage), and 89/336/EEC (Electromagnetic Compatibility) and withthe following standards:

IEC 60601-1-2, IEC 60335-1, and EN 1441

Quality Assurance Manager: Signed: Welch Allyn, Inc. Date: January 7, 2000


Manufacturer: Everest VITAddress: 4619 Jordan Road,




Everest VIT declares under its sole responsibility that the product,

Model Number: PLS500, PLS500D, and PXL C # DD A FFF

Name: XL ProLight System & VideoProbes

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directives 89/336/EEC (Electromagnetic Compatibility) and with the followingstandards:

EN 50081-1, EN 55022, EN 61010-1, and EN 61325

In addition, these products are also in compliance with:

UL 3101-1 and CSA C22.2 No. 1010.1

Quality Assurance Manager Signed : Everest VIT Date: July 12, 2000


Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road





Model Number: 44300, 44302, 44303, 44304, 44306, 44310, 44312, 44313,44316, 44500, 44502, 44503, 44504, 44506, 44510, 44512,44513, and 44516

Name: Halogen Diagnostic Light

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directives 89/336/EEC (Electromagnetic Compatibility) and 73/23/EEC (LowVoltage) and with the following harmonized standards:

EN 60601-1, EN 60601-1-2

In addition, this product is also in compliance with:

UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90, IEC 60601-1, and AS/NZS 3200.1.0

Quality Assurance Manager Signed : Welch Allyn, Inc. Date: January 4, 2001



Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220USA




Model Number: 12500, 12500-D, 12500-Y, 12500-DY, 74290, 74292,74294, 74296, 74354, 74364,74390, 74392, 74394,& 74396

Name: Binocular Indirect Ophthalmoscope

to which this declaration relates is in conformity with the following standardsEN 60601-1, EN 60601-1-2, EN 1441, EN 980, and EN 1041

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class 1 under Rule 12 of Annex IX of thisDirective.








Model Number: 79282, 79284, 79286

Name: Pocket Scope charger


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441


Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 23, 1998

Declaration of ConformityDOCM014





Welch Allyn, Inc., declares under its sole responsibility that the following product,

Model Number: 23200, 23202, 23204, 23205, 23210, 23212,23214, and 23215

Name: AM 232 Manual Audiometer

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directive 93/42/EEC of 14-June-1993 concerning medical devices and withthe following standards:

EN 60601-1, EN60601-1-2, EN 980, EN 1041, and EN 1441

In addition, the product has been classified as Class IIa under Rule(s) #5 & #10 ofAnnex IX of this Directive.


Declaration of ConformityDOCM014a






Model Number: 23220, 23221, 23222, 23223, 72320, and 72329

Name: AM 232 Manual Audiometer Accessories


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441

In addition, the product has been classified as Class I under Rule(s) #1 & #12 ofAnnex IX of this Directive.



Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 U.S.A.

Manufacturing site: Welch Allyn, Inc. Address: Skaneateles Falls, NY USA




Model Number: 26200, 26200-RS, 26202, 26203, 26204, 26205, 26205-RS, 26206, 26207, 26208, 26230, 26230-RS, 26232, 26233, 26234, 26235, 26235-RS, 26236, 26237, and 26238

Name: TM262 AutoTymp


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441

Following the provisions of the European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, the device is Class IIa under rule(s) 5 & 10 of Annex IX of this Directive.



Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA

Manufacturing site: Welch Allyn, Inc. Address: Skaneateles Falls, NY USA




Model Number: 23220, 23221, 23222, 23243, 23244, 26008, 26011, 26013, 26015, 26017, 26019, and 26100

Name: TM 262 AutoTymp Accessories

to which this declaration relates is in conformity with the provisions of the European Council Directive 93/42/EEC of 14-June-1993 concerning medical devices and with the following standards:

EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441

In addition, the product has been classified as Class I under Rule(s) #1 & #12 of Annex IX of this Directive.





Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd,

Arden NC 28704-9739 USA




Model Number: 5100-01, 5100-02, 5100-03, 5100-04, 5100-05, 5100-11,5100-12, 5100-13, 5100-14, 5100-15,

Name: QuietTrak, Ambulatory Blood Pressure Monitor

Is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993,concerning Medical Devices which apply to them. In support of this directive, theseproducts conform to the following standards:

EN 60601-1, EN 60601-1-2, EN 1441, EN 1041:1994, EN 980:1994, and CouncilDirective 80/181/EEC plus amendments.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class II a under rule 10 of Annex IX of thisDirective.

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 31, 1996

Declaration of ConformityNumber : DOCM021a



Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd,

Arden NC 28704-9739 USA




Model Number: 5100-30, 5100-31, 5100-32, 5100-33, 5100-34, 5100-35,5100-36, 5100-37, 5100-38, 5100-39, 5100-41E, 5100-41F, 5100-41G, 5100-41I, 5100-41S, 5100-42E, 5100-42F,5100-42G, 5100-42I, 5100-42S, 5100-43, 5100-44,5100-45, 5100-46, 5100-47, 5100-48, 5100-49, 5100-51, 5100-52,and 5100-53.

Name: QuietTrak, Ambulatory Blood Pressure Monitor Accessories

Is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993,concerning Medical Devices which apply to them. In support of this directive, theseproducts conform to the following standards:

EN 60601-1, EN 60601-1-2, EN 1441, EN 1041:1994, EN 980:1994, and CouncilDirective 80/181/EEC plus amendments.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rules #1 and #12 of Annex IX of thisDirective.







Model Number: 52000-E1, 52000-E2, 52000-E3, 52000-E4, 52000-E6, 52000-F1, 52000-F2, 52000-G2, 52000-G2SW, 52000-I2, 52000-S1, 52000-S2, 5200P-E1, 5200P-E2, 5200P-E3, 5200P-E4, 52000-E6, 5200P-F1, 5200P-F2, 5200P-G2, 5200P-I2, 5200P-S1, 5200P-S2, 520T0-E1, 520T0-E2, 520T0-E3, 520T0-E4, 520T0-E6, 520T0-F1, 520T0-F2, 520T0-G2, 520T0-I2, 520T0-S1, 520T0-S2, 520TP-E1, 520TP-E2, 520TP-E3, 520TP-E4, 520TP-E6, 520TP-F1, 520TP-F2, 520TP-G2, 520TP-I2, 520TP-S1, 520TP-S2, 52S00-E1,52S00-E2, 52S00-E3, 52S00-E4, 52S00-F1, 52S00-F2, 52S00-G2, 52S00-I2, 52S00-S1, 52S00-S2, 52S0P-E1, 52S0P-E2, 52S0P-E3, 52S0P-E4, 52S0P-E6, 52S0P-F1, 52S0P-F2, 52S0P-G2, 52S0P-I2, 52S0P-S1, 52S0P-S2, 52ST0-E1, 52ST0-E2, 52ST0-E3, 52ST0-E4, 52ST0-E6, 52ST0-F1, 52ST0-F2, 52ST0-G2, 52ST0-I2, 52ST0-S1, 52ST0-S2, 52STP-E1, 52STP-E1X, 52STP-E2, 52STP-E3, 52STP-E4, 52STP-E6, 52STP-F1, 52STP-F2, 52STP-G2, 52STP-I2, 52STP-S1, 52STP-S2, 52N0P-E1, 52N0P-E1X, 52N0P-E2, 52N0P-E3, 52N0P-E4, 52N0P-E6, 52N0P-F1, 52N0P-F2, 52N0P-G2, 52N0P-G2SW, 52N0P-I2, 52N0P-S1, 52N0P-S2, 52NTP-E1,52NTP-E1X, 52NTP-E2, 52NTP-E3, 52NTP-E4, 52NTP-E6, 52NTP-F1, 52NTP-F2, 52NTP-G2, 52NTP-I2, 52NTP-S1, 52NTP-S2, 52N00-E1, 52N00-E2, 52N00-E3, 52N00-E4, 52Noo-E6, 52N00-F1, 52N00-F2, 52N00-G2, 52000-G2SW, 52N00-I2, 52N00-S1, 52N00-S2, 52NTO-E1, 52NTO-E2, 52NTO-E3 52NTO-E4, 52NTO-E6, 52NT0-F1, 52NT0-F2, 52NT0-G2, 52NT0-I2, 52NT0-S1, and 52NT0-S2.

Name: Vital Signs Monitor

Is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices that apply to them. In support of this directive, these products conform to the following standards:

EN 60601-1, EN 60601-1-2, IEC 601-2-30, EN 30993-1, EN 1060-1, EN 1060-3, EN 1441, EN 980, EN 1041, and Directive 80/181/EEC.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class IIb under rule(s) 5&10 of Annex IX of this Directive.

Regulatory Manager Signed: Welch Allyn Inc. Date 04/4/2003







Model Number: DA-FFN, DA-FFP, DCU-2000, DCU-3000P, DHP-300P,DHP-390P, DHP-400P, DHP-450P, DHP-500, DHP-590,DHP-600, DHP-650, DLS-300, DLS-400, DXR-100, DXR-200P

Name: Reveal Dental Imaging System


EN 60601-1, EN 60601-1-2, EN 1441, EN 1041, and EN 980

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rule 5 & 12 of Annex IX of this directive.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: November 17, 1998







Model Number: 48622, 48624, 48632, and 48634

Name: Exam Light II


EN 60601-1, EN 980, EN 1041, and EN 1441

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class 1 under Rules 1 and 12, Annex IX of thisDirective.







Model Number: 5079- plus the following extensions 05, 09, 11, 20, 27, 28, 32, 33, 37, 40, 41, 42, 43, 51, 60, 61, 62, 63, 65, 66, 67, 68, 69, 70, 71, 73, 74, 75, 76, 78, 79, 89, 90, 102, 103, 104, 105, 110, 111, 113, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 125C, 126, 127, 130, 131, 132, 134, 135, 136, 137, 139, 140, 141, 142, 144, 145, 146, 147, 149, 150, 151, 152, 154, 155, 156, 157, 159, 160, 161, 162, 164, 165, 166, 167, 169, 170, 172, 173, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 190, 191, 192, 194, 195, 196, 197, 199, 210, 211, 214, 215, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 315, 316, 317, 318, 320, 321, 322, 323, 324, 325, 326, 327, 328. 336, 337, 338, 339, 340, 342, 343, 344, 350, 351, 352, 353, 366, 367, 368, 369, 370, 400, 400V, 401, 402, 405, 410, 411, 412, 413, 414, 17460, 17460-100, 17460-100A, 17461, 17461-100, 17461-100A, 17462, 17462-100, 17462-100A, 17462P, 17462P-100, 17462P-100A, 17463, 17463-100, 17463-100A, 17464, 17464-100, 17464-100A, 17465, 17465-100, and 17465-100A

Name: Stethoscope and Accessories

is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices, which apply to them. In support of this Directive, these products conform to the following standards:

EN 1441: 1994, EN 980: 1994, and EN 1041

Following the provisions of this Directive, theses products are classified as Class I under rule(s) 1 of Annex IX of this Directive.



Manufacturer: Welch Allyn Inc.



Address: Navan Business Park Dublin Road,Navan, County Meath,

Republic of Ireland. Tel. +353 46 67775 Fax.+353 46 27128


Model Number: 46100, 46100TW, 46102, 46104, 46106, 49500, 49500TW,49502, 49502TW, 49504, 49504TW, 49506, 49506TW, 49540, 49540-S, 49700, 49702, 49704, 49706, 49720, 49722, 49724, 49726, 90123, 90126, 90127,90128, 90132, 90142, 90143, HLM 24

Name: Medical Light Source and Accessories


EN 60601-1, EN 60601-1-2, EN 1441, EN 980, and EN 1041: 1994,

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class I under rule(s) 1 & 10 of Annex IX of this Directive.

Regulatory Affairs Dept. Signed: Welch Allyn, Inc. Date: June 11, 2004







Model Number: 76510, 76512, 76514, 76516, 76520, 76522, 76524, 76526, 76710,76712, 76714, 76716, 76720, 76722, 76724, 76726, 76730, 76826,76910, 76912, 76914, 76916, 76920, 76922, 76924, 79282, 79510,79512, 79514, 79516, 79520, 79522, 79524, & 79526

Name: Wall Transformer


EN 60601-1, EN 60601-1-2, EN 1441, EN 980, and EN 1041.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rule(s) 1 & 10 of Annex IX of thisdirective.






Adress: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128


Model Number: 20500H, 20500S, 20502S, 20502H, 20504S, 20504H, 20512S,20512H, 20514S, 20514H, 20522S, 20522H, 20524S, 20524H,20530H, 20530S, 75265, 74185, 75215, 21505, 08500, 05374.

Name: Lumiview, Binocular Otoscope, Bi-otoscope.


EN 60601-1, EN 60601-1-2, EN 1441, EN 980, and EN 1041.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rule(s) 1 & 10 of Annex IX of thisdirective.


Page 1 of 2




Address: Kells Road, Navan, County Meath, Republic of Ireland.

Tel. +353 46 90 67700 Fax.+353 46 90 67754


Model Number: 5080-plus the following extensions 01; 5082- plus the following extensions 01, 02, 03, 06, 07, 08, 11, 16, 18, 21, 22, 23, 24, 25, 26, 42, 43, 44, 45, 56, 58, 59, 61, 62, 63, 64, 65, 67, 68, 70, 71, 72, 73, 74, 75, 76, 141, 142, 143, 144, 81-1, 81-3, 81-3HP, 81-3MQ, 82-1, 82-2, 82-3, 82-4, 82-5, 82-3HP, 82-3MQ, 82-4HP,82-4MQ, 83-1, 83-2, 83-3, 83-4, 83-5, 83-3HP, 83-4HP, 83-3MQ, 83-4MQ, 84-1, 84-2, 84-3, 84-4, 84-5, 84-3HP, 84-4HP, 84-3MQ, 84-4MQ, 84P-1, 84P-2, 84P-3, 84P-4, 84P-5, 84P-3HP, 84P-4HP, 84P-3MQ, 84P-4MQ, 85-1, 85-2, 85-3, 85-4, 85-5, 85-3HP, 85-4HP, 85-3MQ, 85-4MQ, 86-1, 86-2, 86-3, 86-4, 86-5, 86L-1, 86L-2, 86L-3, 86L-4, 86-3HP, 86-4HP, 86-3MQ, 86-4MQ, 86L-3HP, 86L-4HP, 86L-3MQ, 86L-4MQ, 87-1, 87-2, 87-3, 87-4, 87-5, 87L-1, 87L-2, 87-3, 87L-4, 87-3HP,87-4HP, 87-3MQ, 87-4MQ, 87L-3HP, 87L-4HP, 87L-3MQ, 87L-4MQ, 88-1, 88-2, 88-3, 88-4, 88-5, 88-3HP, 88-4HP, 88-3MQ, 88-4MQ, 91-1, 91-3, 91-3HP, 91-8HP, 91-3MQ, 91-8MQ, 91-6, 91-8, 92-1, 92-2, 92-3, 92-4, 92-5, 92-6, 92-7, 92-8, 92-9, 92-3HP, 92-4HP, 92-8HP, 92-9HP, 92-3MQ, 92-4MQ, 92-8MQ, 92-9MQ, 93-1, 93-2, 93-3, 93-4, 93-5, 93-6, 93-7, 93-8, 93-9, 93-3HP, 93-4HP, 93-8HP, 93-9HP, 93-3MQ, 93-4MQ, 93-8MQ, 93-9MQ, 94-1, 94-2, 94-3, 94-4, 94-5, 94-6, 94-7, 94-8, 94-9, 94-3HP, 94-4HP, 94-8HP, 94-9HP, 94-3MQ, 94-4MQ, 94-8MQ, 94-9MQ, 94P-1, 94P-2, 94P-3, 94P-4, 94P-5, 95-1, 95-2, 95-3, 95-4, 95-5, 95-6, 95-7, 95-8, 95-9, 95-3HP, 95-4HP, 95-8HP, 95-9HP, 95-3MQ, 95-4MQ, 95-8MQ, 95-9MQ, 96-1, 96-2, 96-3, 96-4, 96-5, 96-6, 96-7, 96-8, 96-9, 96-3HP, 96-4HP, 96-8HP, 96-9HP, 96-3MQ, 96-4MQ, 96-8MQ, 96-9MQ, 96L-1, 96L-2, 96L-3, 96L-3HP, 96L-3MQ, 96L-4, 96L-4HP, 96L-4MQ, 96L-6, 96L-7, 96L-8, 96L-8HP, 96L-8MQ, 96L-9, 96L-9HP, 96L-9MQ, 97-1, 97-2, 97-3, 97-4, 97-5, 97-6, 97-7, 97-8, 97-9, 97-3HP, 97-4HP, 97-8HP, 97-9HP, 97-3MQ, 97-4MQ, 97-8MQ, 97-9MQ, 97L-1, 97L-2, 97L-3, 97L-3HP, 97L-9HP, 97L-3MQ, 97L-4, 97L-4HP, 97L-4MQ, 97L-9MQ, 97L-6, 97L-7, 97L-8, 97L-8HP, 97L-8MQ, 97L-9, 98-1, 98-2, 98-3, 98-4, 98-4HP, 98-9HP, 98-4MQ, 98-9MQ, 98-5, 98-6, 98-7, 98-8, 98-9, 98-3HP, 98-8HP, 98-3MQ, 98-8MQ, 101-1, 1-01-2, 102-1, 102-2, 103-1, 103-2, 104-1, 104-2, 105-1, 105-2,146, 147, 148, 149, 150, 151, 152, 153, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 173, 176, 180, 181, 182, 183, 184, 201-1, 201-3, 202-1, 202-2, 202-3, 202-4, 202-5, 203-1, 203-2, 203-3, 203-4, 203-5, 204-1, 204-2, 204-3, 204-4, 204-5, 204P-1, 204P-2, 204P-3, 204P-4, 204P-5, 205-1, 205-2, 205-3, 205-4, 205-5, 206-1, 206-2, 206-3, 206-4, 206-5, 206L-1, 206L-2, 206L-3, 206L-4, 207-1, 207-2, 207-3, 207-4, 207-5, 207L-1, 207L-2, 207L-3, 207L-4, 208-1, 208-2, 208-3, 208-4, 208-5, 211-1, 211-3, 212-1, 212-2, 212-3, 212-4, 212-5, 213-1, 213-2, 213-3, 213-4, 213-5, 214-1, 214-2,

Page 2 of 2

214-3, 214-4, 214-5, 214P-1, 214P-2, 214P-5, 215-1, 215-2, 215-3, 215-4, 215-5, 216-1, 216-2, 216-3, 216-4, 216-5, 217-1, 217-2, 217-3, 217-4, 217-5, 218-1, 218-2, 218-3, 218-4, 218-5, 221-1, 222-1, 222-2, 223-1, 223-2, 224-1, 224-2, 224P-1, 225-1, 225-2, 226-1, 226-2, 226L-1, 227-1, 227-2, 227L-1, 228-1, 228-2, 231-1, 232-1, 232-6, 232-2, 233-1, 233-2, 233-6, 234-1, 234-2, 234-6, 234P-1, 235-1, 235-2, 235-6, 236-1, 236-2, 236-6, 236L-1, 236L-6, 237-1, 237-2, 237L-1, 237-6, 237L-6, 238-1, 238-2, 238-6, 241-1, 241-2, 241-3, 241-4, 241-5, 241-6, 241-7, 241-8, 241-9, 241-10, 241-17, 241-18, 241-19, 241-20, 241-3HP, 241-4HP, 241-7HP, 241-8HP, 241-3MQ, 241-4MQ, 241-7MQ, 241-8MQ, 5084 - plus the following extensions – 81-1, 81-3, 81-3MQ, 82-1, 82-2, 82-3, 82-3MQ, 82-4, 82-4MQ, 83-1, 83-2, 83-3, 83-3MQ, 83-4, 83-4MQ, 84-1, 84-2, 84-3, 84-3MQ, 84-4, 84-4MQ, 84P-1, 84P-2, 84P-3, 84P-3MQ, 84P-4, 84P-4MQ, 85-1, 85-2, 85-3, 85-3MQ, 85-4, 85-4MQ, 86-1, 86-2, 86-3, 86-3MQ, 86-4, 86-4MQ, 86L-1, 86L-2, 86L-3, 86L-3MQ, 86L-4, 86L-4MQ, 87-1, 87-2, 87-3, 87-3MQ, 87-4, 87-4MQ, 87L-1, 87L-2, 87L-3, 87L-3MQ, 87L-4, 87L-4MQ, 88-1, 88-2, 88-3, 88-3MQ, 88-4, 88-4MQ, 91-1, 91-3, 91-3MQ, 92-1, 92-2, 92-3, 92-3MQ, 92-4, 92-4MQ, 93-1, 93-2, 93-3, 93-3MQ, 93-4, 93-4MQ, 94-1, 94-2, 94-3, 94-3MQ, 94-4, 94-4MQ, 95-1, 95-2, 95-3, 95-3MQ, 95-4, 95-4MQ, 96-1, 96-2, 96-3, 96-3MQ, 96-4, 96-4MQ, 96L-1, 96L-2, 96L-3, 96L-3MQ, 96L-4, 96L-4MQ, 97-1, 97-2, 97-3, 97-3MQ, 97-4, 97-4MQ, 97L-1, 97L-2, 97L-3, 97L-3MQ, 97L-4, 97L-4MQ, 98-1, 98-2, 98-3, 98-3MQ, 98-4, 98-4MQ, 101-1, 101-2, 102-1, 102-2, 103-1, 103-2, 104-1, 104-2, 105-1, 105-2; 5086- plus the following extensions 01, 03, 04, 05, 06;5087- plus the following extensions 14, 15; 5088- plus the following extensions 01, 05; 06, 06H, 5089- plus the following extensions 01, 01DM, 02, 03, 04, 09, 11, 12, 13, 18, 19, 21, 22, 25, 26, 30, 31, 32, 33, 34, 35, 36, 37, 38; 5091- plus the following extensions 13, 41, 47, 48, 62; 5097- plus the following extensions 17, 36; 5098- plus the following extensions 79; 5200- plus the following extensions 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 25, 51, 68, 70; 7052- plus the following extensions 35, 36, 37

Name: Blood Pressure Accessories

is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices, which apply to them. In support of this Directive, these products conform to the following standards:

EN 1441, EN 980, and EN 1041

Following the provisions of this Directive, theses products are classified as Class I under rule(s) 1 of Annex IX of this Directive.

Regulatory Affairs Manager Signed: Welch Allyn, Inc.

Date: Sept 15, 2004







Model Number: 88000, 88000A, 88001, 88001A, 88002, 88002A, 88004, 88004A,88005, 88005A, 88006, 88006A, 88100, 88110, 89000, 89000A,89001, 89001A, 89002, 89002A, 89004, 89004A, 89005, 89005A,89006, 89006A, 89100, and 89110

Name: Video Colposcope

EN 60601-1, and EN 60601-1-2

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rules 1 & 12 of Annex IX of thisdirective.

Quality Assurance Manager Signed:Welch Allyn, Inc. Date: January 8, 2001






Welch Allyn, Inc., declares that the following product:

Model Number: 23621, 23622, 23623, 23624, 23630, 23639, and 72900

Name: MicroTymp 2 Accessories

to which this declaration relates is in conformity with the provisions of the EuropeanCouncil Directive 93/42/EEC of 14-June-1993 concerning medical devices and with thefollowing standards:

EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 61027, and ISO 10993

In addition, the product has been classified as Class I under Rule(s) #1 & #12 of Annex IXof this Directive.







Welch Allyn, Inc., declares that the following product:

Model Number: 23640, 71170, 71172, 71174, 71175, 71176, 71179, 711772.92360, 92362, 92362F, 92362G, 92362S, 92364, 92366, 92369,93690, 93692, 93692F, 93692G, 93692S, 93694, 93695, 93696,and 93699

Name: MicroTymp 2


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 61027, and ISO 10993

In addition, the product has been classified as Class IIa under Rule(s) #5 & #10 of AnnexIX of this Directive.








Model Number: 23300, 23301, 92600, 92632, 92632F, 92632G, 92632S,92634, 92635, 92636, 92639, 92680, 92682, 92682F,92682G, 92682S, 92684, 92685, 92686, AND 92689

Name: AudioScope 3


EN 60601-1, EN 60601-1-2, EN 908, EN 1041, and ISO 10993

In addition, the product has been classified as Class IIa under Rule(s) #5 & #10 ofAnnex IX of this Directive.








Model Number: 23303, 23305, 23307, 23400, 71025, 71032, 71034, 71036,71039, 71040, 71123, 72300, 72322, 72324, 72325, and72326

Name: AudioScope 3 Accessories


EN 60601-1, EN 60601-1-2, EN 908, EN 1041, and ISO 10993

In addition, the product has been classified as Class I under Rule(s) #1 & #12 of Annex IXof this Directive.



Manufacturer: Welch Allyn, Inc.Address: 4619 Jordan Road


Manufacturing site: Welch Allyn, Inc.4619 Jordan RoadSkaneateles Falls, NY 13153-0220USA




Model Number: 48901, 48911, 48010, and 48020

Name: VDX-300 Imaging and Illumination Platform. DistalVu II Laparoscope.


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 60601-2-18, andEN 1441



Declaration of Conformity Number : DOCM057

Manufacturer: Welch Allyn Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 U.S.A.

Manufacturing site: Welch Allyn Ltd Address: Kells Road, Navan, County Meath, Republic of Ireland

Representative: European Regulatory Manager, Welch Allyn Ltd. Kells Road, Navan, County Meath, Republic of Ireland. Tel. +353 46 79075 Fax. +353 46 27128

We Welch Allyn declare under our sole responsibiity that the Product

Model Number: DC-104, DC-107, DP-1010, DP-1030-3, DP-1040, DP-1050,DP1500-2, DP1500-4, DP-1500-6, DP1510-2, DP1510-4, DP-1510-6, DP1540-2,DP1540-4, DP-1540-6, DP-1545, DP-1550, DP-2000-1, DP-2000-2, DP2000-4,DP2000-6, DP2040-2, DP2040-4, DP 2040-6, DP-3000, DP-3500, DP-4000, DP-5000

Name: DenLite Dental Illumination System


EN 60601-1, EN 60601-1-2, EN 1441, EN 980, EN 1041.



Regulatory Manager Signed : Welch Allyn, Inc. Date: February 4, 1998


Manufacturer: Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0200 USA

Manufacturing Address: Welch Allyn, Inc. 7420 Carroll Road,

San Diego, CA 92121 USA


Address: Dublin Road, Navan, County Meath,

Republic of Ireland. Tel. +353 46 67775 Fax. +353 46 27128

Welch Allyn, Inc. declares under its sole responsibility that the following product,

Model Number: 675, 678, 679, 767, 690, 692 and 986

Name: SureTemp Electronic Thermometers

to which this declaration relates is in conformity with the provisions of the European Council Directive 93/42/EEC of 14-June-1993 concerning medical devices and with the following standards:

EN 60601-1, EN 60601-1-2, EN 980, and EN 1041

In addition, the product has been classified as Class IIa under Rule(s) #5 and #10 of Annex IX of this Directive.

Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: December 3, 2003




Representative European Regulatory Manager,Welch Allyn Ltd.



Model Number: 500-N, 500-P, 5191-100, 5191-200, 5191-M, 5191-MP,AMD-300, AMD-300SP, BYR-300, BYR300P, LCI-300, LCI-300P,MRV2000, MRV2000P

Name: VDX-300 Light Sources


EN 60601-1, EN 60601-1-2, EN 1441, EN 980, and EN 1041


Quality Assurance Manager Signed: Welch Allyn, Inc. Date: June 22, 1998




Representative European Regulatory Manager,Welch Allyn Ltd.



Model Number: 00710-21, 00710-22, 00710-31, 00710-32, 00710-41,00710-42, 00710-51, 00710-52, 00710-61, 00710-62,00710-71, 00710-72, 00710-81, 00710-82, 00710-91,00710-92, and 11223

Name: FDT Visual Field Instrument


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, and ISO 10993-1








Model Number: 60713, 60813, 60814, 60815, 60835, 68060, 68061, 68062, 68063, 68064, 68065, 69061, 69062, 69063, 69064, 69211, 69212, 69213, 69214,

Name: Fiber Optic Laryngoscopes


EN60601-1, EN60601-1-2, EN980, EN1041, EN1441, EN1819, and ISO 7376-3

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rule 12 of Annex IX of this Directive.







Model Number: 60200, 60300, 60305, 60400, 60710, 63470, 63471, 63482, 63483, 63484, 66471, 66482, 66483, 66484, 67471, 67482, 67483, 67484,68040, 68041, 68042, 68043, 68044, 60845, 68095, 68470, 69041,69042, 69043, 69044, 69241, 69242, 69243, 69244

Name: Standard Laryngoscopes


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, and ISO 7376-1









Model Number: 26030

Name: Bi-valve Illuminator


EN 60601-1, EN 60601-1-2, EN 980, EN 1041: 1994, and EN 1441









Model Number: 11470, 11710, 11720, 11730, 11735, 11750, 11751, 11755,11770, 11771, 11790, 11791, 11795, 11800, 11801, 11810, 11811,11820, 11821,11830, 11831, 12222, 12224, 12226, 12610, 12612,12800, 12810, 12811, 12812, 12813, 12814, 12820, 12821, 12830,12831, 12860, 12861, 13000, 13010, 14680, 14681, 19000, 19001,19090, 19091, 19092, 19093, 19190, and 19192

Name: Ophthalmoscopes


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441









Model Number: 12452, 12454

Name: Strabismoscope


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441








Model Number: 16210, 16220, 16220-S, 16221, 17682, 17684, 17782, 17784, 17792,17794, 18200, 18235, 18240, 18245, 18312, 18314, 18322, 18324,18332, 18334, 18342, 18344, 18412, 18414, 18422, 18424

Name: Retinoscope


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441


Sr. Regulatory Affairs Manager Signed: Welch Allyn Inc. Date: September 25, 2003






Model Number: 60200, 60300, 60305, 60400, 60710, 60762, 60764, 60813, 60814, 60815, 70000, 70160, 70500, 70700, 70710, 70715, 70720, 70720-C, 70762, 70764, 71000, 71000-A, 71000-B, 71000-C,71010, 71020, 71020-B, 71020-C, 71062, 71062-C, 71064, 71500, 71670, 71911, 71941, 72800, 72801, 72820, 72830, and 72831

Name: Battery Handles


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441


Quality Assurance Manager Signed: Welch Allyn, Inc. Date: November 9, 2001







Model Number: 92132, 92134, 93312, 93314

Name: Compact Sets


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441









Model Number: 92802, 92804, 92812, 92814, 94812, 94814, and 92821

Name: Pocketscope


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441



Page 1 of 2






Model Number: 18335-CS, 18335-DS, 18335-SS, 26722, 27672, 71222, 71224, 71226, 71242, 71744, 71746, 71772, 71772-RO, 71774, 71774-RO, 71776, 71776-RO, 71782, 71784, 71792, 71794, 71822-SM, 71824-SM, 71824-VP, 71824-VPSM, 71826-RO, 71842-SM, 71844-SM, 71846-RO, 71852-SM, 71854-SM, 71856-SM, 71882-SM, 71884-SM, 71886-SM, 92000, 92100, 92800, 92801, 92802, 92803, 92804, 92805, 92806, 92812, 92813, 92814, 92815, 92816, 92820, 92820M, 92821, 92821M,92830, 93102, 93104, 93152, 93154, 93172, 93174, 93176, 93202, 93204, 93272, 93300, 93310, 93312, 93314, 93400, 93410, 93412, 93414, 93702, 93704, 93712, 93714, 93762, 93764, 96122, 96124, 96172, 96174, 96222, 96224, 96272, 96274, 96722, 96723, 96724, 96725, 96732, 96762, 96763, 96764, 96765, 97102, 97104, 97112, 97114, 97122, 97124, 97150 BI, 97152, 97154, 97172, 97174, 97200, 97201, 97202, 97204, 97210, 97212, 97214, 97222, 97224, 97250, 97252, 97254, 97272, 97274, 97302, 97304, 97312, 97314, 97322, 97352, 97372, 98512, 98514, 98602, 98712, 98713, 98714, 98715, 98762, 98763, 98764, 98765

Name: Diagnostic Set


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441


Page 2 of 2

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 10, 2001




Manufacturing site: Diatek InstrumentsAddress: 7420 Carroll Road,

San Diego, CA 92121USA





Name: InstaTemp 9000, Clinical Thermometer


EN 60601-1, EN 60601-2, EN 980, and EN 1041

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class IIa under rule(s) 5 & 10 of Annex IX ofthis directive.

Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: March 4, 1998






Model Number: 11792, 71114, 71116, 71118, 71119, 71120, 71140, 71142, 71144, 71146, 71154, 71156, 71158, 71160, 71214, 71216,71218, 71227, 71254, 71256, 71258, 71260, 71614, 71616,71618, 71620, 71654, 71656, 71658, 71660, 71712, 71714,71716, 71722, 71724, 71726, 71732, 71734, and 71736

Name: Desk Power Source


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441








Model Number: 30210, 32010, 32020, 32052, 32056, 32062, 32066, 32410,32420, 32452, 32456, 32462, 32466, 32810, 32820, 32830, 32852, 32856, 32862, 32866, 32872, 32876, 32952, 32956, 32972, 32976, 33062, 33066, 33220, 33262, 33266, 33620, 33662, 33666, 33762, 33766, 33830, 33872, 33876, 35323, 35326, 35392, 35396, 36019, 36142, 37019, 37023, 37027, 37152, 37156, 37162, 37166, 37172, 37176, 38108, 38114, 38119, 38122, 38208, 38214, 38219, 38222, 38614, 38619, 38622, 38700, 38714, 38719, 38722, 38850, 38900, 39614, 39619, 39622, 39714, 39719, 39722, 53110, 53130, 73210, 73322, and 73324

Name: Reusable Sigmoidoscopes and Anoscopes


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, and IEC 601-2-18

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rules 5 & 12 of Annex IX of this Directive.

Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: May 4, 2004




Address: Navan Business Park Dublin Road,Navan,County Meath,



Model Number: 58000, 58000S, 58001, 58001S, 58002, 58003, 58004, 58004S, 58005, 58006, 58014, 58600, 58601, 73305, 73322, 73323, 73324, 73326, 73405, 73410, 73411, 73412, 73414, 73415, 73416, 78000, 78103, 78105, 78110, 78114, 78115, 78116, 78600, 78800, 78810, 78812, 78814, 78815, 78816, and 78820

Name: Vaginal Speculum and Illumination System


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and ISO 14971


Sr. Mgr. Regulatory Affairs Signed: Welch Allyn Inc. Date January 6, 2004




Manufacturing Site Welch Allyn, Inc.Address: Kells Road, Navan,

County Meath,Republic of Ireland.




Model Number: 243032, 243033, 243034, 243035

Name: Ear Speculum, EarSpec


EN 980 and EN 1040

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class 1 under Rule #5 of Annex IX of thisDirective.

Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: July 5, 1998




Manufacturing Site Welch Allyn, Inc.Address: Kells Road, Navan,

County Meath,Republic of Ireland.




Model Number: 19090, 19091, 19092, 19093, 19190, 19191, 19192,19193, 29090, 29092, 99090, 99091, 99092, and 99093

Name: Klinic Ophthalmoscope and Otoscope


EN 980 and EN 1040

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class 1 under Rule #5 of Annex IX of thisDirective.

Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: July 14, 1998







Model Number: 47300, 47310, 47320, 47351, 47352, 47352-C, 47354,and 47370

Name: Episcope


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and EN 1441

In addition, the product has been classified as Class I (with measure) under Rule(s) #1and #12 of Annex IX of this Directive.







We Welch Allyn declare under our sole responsibility that the Product

Model Number: 04980, 49800, 49801, 49802, 49804, 49806, and 49850

Name: Xenon Light Source


EN 60601-1, EN 980, EN 1041, and EN 1441

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class 1 under Rules 1 and 12, Annex IX of thisDirective.








Model Number: 28000 and 28100

Name: Tongue Blade Holder


EN 60601-1, EN 980, and EN 1041









Model Number: 22009, 26530, 26535, 26550, 27000, 27010, 27050,27060, 27070, 27200, 27250, 27270, 41000, 41001, 41002,41100, 41101, 41102, 43200, and 43300

Name: Illuminators and Transilluminators


EN 60601-1, EN 980, and EN 1041






Manufacturing site: Speidel + Keller GmbH & Co. KGAddress: Zollerstrasse 2-4

D-72417 JungingenGermany




Model Number: 45-15-389, 45-15-489, 45-15-589, 50-31-189, 50-81-189, and 50-84-189

Name: Mechanical Sphygmomanometer


EN 1060-1, EN 1060-2, EN 980, and EN 1041.

The quality system that controls the manufacture and design of this product complies with thefollowing standards, EN ISO 9001:1994 and EN 46001:1993. The TUV-Zertifizerungsgemeinschaft e.V. has authorized the application of their Notified Body number inconjunction with the CE marking of conformance applied to this product family.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerningmedical devices. Device is Class I with a measuring function under rule 1 of Annex IX of thisdirective.

Regulatory Affairs Manager Signed : Welch Allyn, Inc. Date: February 12, 1999







Model Number: 31500, 31530, 31550, 31750, and 45500

Name: VideoPath Endoscopes


EN 60601-1, EN 60601-1-2, EN 60601-2-18, EN 980, EN 1041, and EN 1441

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class IIa under Rules 6 and 10 of Annex IX ofthis Directive.





Manufacturing site: Welch Allyn, Inc.Address: 4619 Jordan Road

Skaneateles NY 13153-0220USA




Model Number: DXU-1000

Name: C.O.D.X.


EN 60601-1, EN 60601-1-2, EN 1441, EN 1041, and EN 980

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class I under rule 5 & 12 of Annex IX of this directive.








Model Number: 621SO, 621SP, 622SO, 622SP, 622NO, 622NP, 623SP, and623NP

Name: Atlas Monitor


EN 60601-1, EN 60601-1-2, EN 60601-1-4, IEC 60601-2-30, EN 60601-2-27, EN1060-1, EN 1060-3, EN 475, EN 864, EN 865, and ISO 9918

In addition, the product has been classified as Class IIb under Rule(s) #5 and #10 ofAnnex IX of this Directive.








Model Number: 29200, 29210, and 29220

Name: AudioPath


EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, IEC 60645-1,and ISO 10993-1

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993concerning medical devices. Device is Class IIa under Rule(s) #5 & #10 of Annex IXof this Directive.





Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd

Arden, NC 28704USA




Model Number: 5100-plus the following extensions 61, 62, 63, 64, 65, 66P, 66A,66D, 66C, 67E, 67G, 67S, 67I, 67F, 67P, 67A, 67D, 67C, 68, 77E,77G, 77S, 77I, 77F, 77P, 77A, 77D

Name: QTrak98

is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993,concerning Medical Devices, which apply to them. In support of this Directive, theseproducts conform to the following standards:

EN 1441, EN ISO 9001, EN 46001, EN 1041, and EN 980

Following the provisions of this Directive, theses products are classified as Class I underrule(s) 1 of Annex IX of this Directive.








Model Number: 14000, 14001, 14002, 14004, 14006, 14010, 14012, 14014,and 14016

Name: SureSight Vision Screener


EN 60601-1, EN 60601-1-2, EN 60601-1-4, EN 980, EN 1041, EN 1441,EN 15004, and IEC 60825-1

In addition, the product has been classified as Class IIa under Rule #10 of Annex IX ofthis Directive.

Quality Assurance Manager Signed: Welch Allyn, Inc. Date: October 5, 1999




Address: Kells Road, Navan, County Meath, Republic of Ireland. Tel. +353 46 67775 Fax. +353 46 27128


Model Number: 5090- plus the following extensions 01, 01LM, 01W, 02, 02CB, 02LM, 02W, 03, 03LM, 03W, 06, 06CB, 06W, 14, 14CB, 14W, 22, 27, 37, 37CB, 37W, 41, 41CB, 41W, 66K; 5091- plus the following extensions 22, 22CB, 22W, 23, 23M, 23W, 38, 38C, 38CB, 38CCB, 38K, 38W, 39, 39W, 41, 41CB, 41K, 41T9, 41T9A, 41W, 41WT9, 41WT9A, 41WTIR, 44, 44A, 46, 48, 60, 60CB, 60W, 60WCB, 61, 61CB, 61W, 67, 67CB; 5097- plus the following extensions 11, 11NM, 13, 26, 26CB, 26NM, 28, 28NM, 29, 29CB, 29NM, 30, 30CB, 30K, 30NM, 35; 35NM, 37, 37W; 5098- plus the following extensions 02, 02CB, 02W, 03, 03W, 05, 05CB, 05W, 06, 06CB, 06W, 11, 11CB, 11W, 18, 18CB, 18K, 18W, 20, 20CB, 20K, 20W, 23, 23CB, 23W, 23WCB, 26, 26CB, 26W, 26WCB, 27, 27CB, 28, 28CB, 29, 29CB, 30, 30CB, 30K, 31, 32, 32CB, 33, 33CB, 42, 42CB, 70, 70CB, 71, 71CB, 72, 72CB, 73, 73CB, 74, 75, 76, 79, 93K, 94K, 95K; 7050- plus the following extensions 14, 14CB, 14CBX, 14CC, 14W, 14WX, 14X, 15, 15W, 15WX, 15X, 23, 23CB, 23CBX, 23W, 23WX, 23X, 24, 24CB, 24CBX, 24W, 24WX, 24X, 29, 29X, 36, 36X, 37, 38K, 38KX, 39, 39X, 43, 43CB, 43CBX, 43X; 7670-plus the following extensions 01, 01C, 01CB, 01CCB, 01D, 01LFM, 01M, 01R, 01W, 02, 02W, 03, 03CB, 03K, 03W, 04, 04CB, 04T9, 04T9A, 04TIR , 04W, 04WTIR, 04WT9, 04WT9A, 10, 10CB, 10W, 11, 11CB, 11W; DS44- plus the following extensions 09, 09C, 09CB, 09CV, 09CVW, 09CW, 09P, 09PC, 09PCB, 09CBW, 09PCBW, 09PCV, 09PCVW, 09PCW, 09PV, 09PVW, 09V, 09VW, 09W, 09PW, 10, 10C, 10CV, 10CVW, 10CW, 10V, 10VW, 10W, 11, 11C, 11CB, 11CBW, 11CN, 11CV, 11CVW, 11CW, 11V, 11VW, 11W, 12, 12C, 12CB, 12CBW, 12CV, 12CVW; 12CW, 12V, 12VW, 12W, 13CB, 13CBW, DS45- plus the following extensions 09, 09C, 09CB, 09CE, 09CW, 09CWE, 09E, 09P, 09PC, 09CB, 09CBW, 09PCB, 09PCBW, 09PCB, 09PCE, 09PCW, 09PCWE, 09PE, 09PW, 09PWE, 09W, 09WE, 10, 10C, 10CE, 10CW, 10CWE, 10E, 10W, 10WE, 11, 11C, 11CB, 11CBW, 11CE, 11CW, 11CWE, 11E, 11W, 11WE, 12, 12C, 12CB, 12CBW, 12CE, 12CW, 12CWE, 12E, 12W, 12WE, 13CB, 13CBW; 590200, 590200PR, 590300, 590300D, 590300PR

Name: Mechanical Sphygmomanometer.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices, which apply to them. Following the provisions of this Directive, these products are classified as Class I with a measuring function under rule 1 of Annex IX of this directive. In support of this Directive, these products conform to the following standards.

EN 60601-1, EN 1060-1, EN 1060-2, EN 980 and EN 1041.

The quality system that controls the manufacture and design of this product complies with the following standards, EN ISO 9001:1994 and EN 46001:1993. The National Standards Authority of Ireland has authorised the application of their Notified Body number 0050 in conjunction with the CE marking of conformance applied to this product family.







Model Number: 48700, 48722, 48724, 48726, 48728, 48740, 48742, 48744, 48746, 48748, 48760, 48762, 48764, 48766, 48768, 48770, 48772, 48774, 48776, 48778, 48780, 48782, 48784, 48786, 48788, 48800, 48822, 48824, and 48826

Name: Exam Light III


IEC 60601-1, EN 980, EN 1041, and EN 1441

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rule(s) #1 and #12 of Annex IX of this Directive.

Quality Assurance Manager: Signed: Welch Allyn, Inc. Date: August 29, 2000



Manufacturing Site Welch Allyn, Inc. Address: Skaneateles Falls, NY USA




Model Number: 4200-N0B, 42N0B-C2, 42N0B-C3, 42N0B-C4, 42N0B-E1, 42N0B-E1-M, 42N0B-E1-M-HSC, 42N0B-E1-M-RK, 42N0B-E1-M-SRX, 42N0B-E1-SRX, 42N0B-E2, 42N0B-E2-M, 42N0B-E3, 42N0B-E3-M, 42N0B-E4, 42N0B-E4-M, 42N0B-E6, 42N0B-E6-M, 42N0B-EC2, 42N0B-F1, 42N0B-F2, 42N0B-F2-M, 42N0B-G2, 42N0B-G2-M, 42N0B-I2, 42N0B-I2-M, 42N0B-J2, 42N0B-P1, 42N0B-P2, 42N0B-P2-M, 42N0B-S1, 42N0B-S1-M, 42N0B-S2, 42N0B-S2-M; 4200-NTB, 42NTB-C3, 42NTB-C4, 42NTB-E1, 42NTB-E1-M, 42NTB-E1-M-HSC, 42NTB-E1-M-PAN, 42NTB-E1-M-RK, 42NTB-E1-M-SCH, 42NTB-E1-M-SRX, 42NTB-E1-PAN, 42NTB-E1-SCH, 42NTB-E1-SRX, 42NTB-E1T, 42NTB-E1X, 42NTB-E2, 42NTB-E3, 42NTB-E3-M, 42NTB-E4, 42NTB-E4-M, 42NTB-EC2, 42NTB-F1, 42NTB-F1-M, 42NTB-F2, 42NTB-F2-M, 42NTB-G2, 42NTB-G2-M, 42NTB-I2, 42NTB-I2-M, 42NTB-J2, 42NTB-P1, 42NTB-P2, 42NTB-P2-M, 42NTB-S1, 42NTB-S1-M, 42NTB-S2, 42NTB-S2-M; 4200-00B, 4200B-C3, 4200B-C4, 4200B-E1, 4200B-E1-M, 4200B-E1-M-HSC, 4200B-E1-M-RK, 4200B-E1-M-SRX, 4200B-E1-SRX, 4200B-E2, 4200B-E2-M, 4200B-E3, 4200B-E3-M, 4200B-E4, 4200B-E4-M, 4200B-E6, 4200B-E6-M, 4200B-EC2, 4200B-F1, 4200B-F2, 4200B-F2-M, 4200B-G2, 4200B-G2-M, 4200B-I2, 4200B-I2-M, 4200B-J2, 4200B-P1, 4200B-P2, 4200B-P2-M, 4200B-S1, 4200B-S1-M, 4200B-S2, 4200B-S2-M; 4200-0TB, 420TB-C3, 420TB-C4, 420TB-E1, 420TB-E1-M, 420TB-E1-M-HSC, 420TB-E1-M-PAN, 420TB-E1-M-RK, 420TB-E1-M-SCH, 420TB-E1-M-SRX, 420TB-E1-PAN, 420TB-E1-SCH, 420TB-E1-SRX, 420TB-E2, 420TB-E2-M, 420TB-E3, 420TB-E3-M, 420TB-E4, 420TB-E4-M, 420TB-E6, 420TB-E6-M, 420TB-EC2, 420TB-F1, 420TB-F1-M, 420TB-F2, 420TB-F2-M, 420TB-G2, 420TB-G2-M, 420TB-I2, 420TB-I2-M, 420TB-J2, 420TB-P1, 420TB-P2, 420TB-P2-M, 420TB-S1, 420TB-S1-M, 420TB-S2, 420TB-S2-M.

Name: Spot Check Device


EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, EN 1060-1, EN 1060-3, EN 1441, EN 980, and EN 1041

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class IIa under Rule(s) #5 & #10 of Annex IX of this Directive.








Model Number: 4200-60, 4200-62, 4200-64, 4200-70, 4200-84, 4200-170, 4200-200, 4200-250

Name: Spot Check Device Accessories


EN 60601-1, EN 60601-1-1, EN 60601-1-2, EN 60601-1-4, EN 1060-1, EN 1060-3, EN 1441, EN 980, and EN 1041

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class I under Rule(s) #1 & #12 of Annex IX of this Directive.






Address: Navan Business Park, Dublin Road Navan, County Meath,




Name: Ear Wash System


EN 30993-1, EN 46001, ISO 9001


Quality Assurance Manager Signed: Welch Allyn, Inc. Date: October 7, 2002


Manufacturer: Welch Allyn, Inc. Address: 4619 Jordan Road, Skaneateles Falls, NY 13153-0220 USA





Model Number: HLM-24, LB60MED-001, LB60MED-002, LB60MED-003, LB60MED-004, LB60MED-005, LB60MED-006, 90123, 90130, 90132, 90137, 90155, and 90157

Name: Medical Light Box


EN 60601-1 and EN 60601-1-2


Corporate Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: January 2, 2003


Manufacturer: Speidel + Keller GmbH & CoKGWelch Allyn CompanyZollerstr. 2-4D – 72417 Jungingen

Representative: European Regulatory ManagerD- 72417 JungingenTel: ++49 7477 92710Fax: ++49 7477927190

We Speidel + Keller / Welch Allyn declare under our sole responsibility that the Product

Model: Primus 50 Art.No. 50-01-189, 50-81-189, Primus 68 Art.No. 50-04-189, 50-84-189,Manuell 50 Art.No 50-16-189, 50-96-189, Manuell 68 Art.No.50-17-189, 50-97-189Disytest Art.No.52-09-189, Disytest Home Art.No. 52-04-187,Oscillophon Art.No. 51-72-126, 51-72-184, Primus Home Art.No. 52-04-187,Primus Stabil 3 Art.No. 50-25-189, Manuell Stabil 3 Art.No. 50-63-189,Priumus Stabil 3 Color Art.No. 50-AA-129, 50-AA-139, 50-AA-149, 50-AA-169,Stabil 3 Home Art.No. 50-26-187, Fixomed Art.No. 50-91-189,ISO Stabil 5 Art.No. 50-71-189, 50-76-199, 50-70-970, 55-76-960,Minimus Art.No. 51-02-189, Altera Art.No. 56-01-184,Maxi Stabil 3 Art.No. 59-30-189, 59-31-189, 59-32-18959-34-189, 59-35-189,Miniatur B Art.No. 65-11-189, Mercuro 300 Art.No.73-06-189, 73-07-189,Art.No. 73-08-189, 74-01-189,SPOO Art.No 50-32-189, SPI Art.No. 50-06-189, SPII Art.No. 50-30-189,Hand 2003 Art.No. 50-07-189.

Name: Mechanical Sphygmomanometer with accessories cuff, valve, stethoscope.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class I with measurement function under rule 1 of Annex V of this directive.In support of this Directive, these products conform the following standards.

EN 1060-1, EN 1060-2, EN 980 and EN 1041.

The quality system that controls the manufacture and design of this product complies with thefollowing standards, EN ISO 9001:1994, and EN 46001:1993. The National Nodyfied BodyTÜV Product Service has authorised the application of their Nodyfied Body number 0123 inconjunction with the CE marking of conformance applied of this product family.

Declaration of Conformity valid since: 17.03.1999

Quality Management Signed: Herbert BiermannSpeidel + Keller / Welch Allyn Date: 17.03.1999





Model: Cuff with Art.No.45-07-184, 45-15-189, 45-15-389, 45-15-489, 45-15-589, 45-16-199,45-17-187, 45-17-184, 45-19-184, 45-19-284, 45-22-189, 45-23-189,45-61-189, 45-AA-129, 45-AA-139, 45-AA-149, 45-AA-169, 45-AA-189,45-94-127, 45-95-127,46-22-189, 46-AA-189, 46-AA-182, 46-22-182, 47-15-282, 47-15-389,47-15-382, 47-15-482, 47-15-489, 47-15-589, 47-19-100, 47-22-189,47-22-182, 47-23-182, 47-23-189, 47-AA-182, 47-AA-189, 47-61-329,48-28-124, 48-28-224, 48-28-324, 48-28-424, 48-15-184, 48-15-284,48-61-384, 48-61-484, 48-15-182,48-15-282, 48-61-382, 48-61-482,49-15-126, 49-15-184.

Name. Cuff / accessories for blood pressure unit or as single product.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class I under rule 1 of Annex V of this directive.In support of this Directive, these products conform the following standards.

EN 1060-1, EN 1060-2, EN 980 and EN 1041.








Model: OSZ 3 Easy, Memo, Pro with Art.No. 55-31-187, 55-27-127, 55-29-127OSZ 4 with Art.No. 55-94-127,OSZ 5 Easy, Memo, Pro with Art.No. 55-95-127, 55-97-127, 55-98-127

Name: Electronical Sphygmomanometer oscillometric measurement method.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class II under rule 1 of Annex II Point 3. of this directive.In support of this Directive, these products conform the following standards.

EN 1060-3, EN 980 and EN 1041.

The quality system that controls the manufacture and design of this product complies with thefollowing standards, EN ISO 9001: 1994, and EN 46001: 1993. The National Nodyfied BodyTÜV Product Service has authorised the application of their Nodyfied Body number 0123 inconjunction with the CE marking of conformance applied of this product family.







Model: Planoscope 30 Art.Nr. 83-12-020, 83-12-030, 83-12-040, 83-12-060, 83-12-080Planoscope 40 Art.Nr. 83-11-020, 83-11-030, 83-11-040, 83-11-060, 83-11-080Duophon 30 Art.Nr. 82-15-020, 82-15-030, 82-15-040, 82-15-060, 82-15-080Duophon 40 Art.Nr. 82-11-020, 82-11-030, 82-11-040, 82-11-060, 82-11-080Professional Art.Nr. 86-01-010, 86-01-020, 86-01-040, 86-01-080,

86-11-010, 86-11-020, 86-11-040, 86-11-080,

Name. Stethoscope / intercept of the heart frequencyaccessories for blood pressure unit or as single product.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class I under rule 1 of Annex V of this directive.In support of this Directive, these products conform the following standards.

EN 1060-1, EN 1060-2, EN 980 and EN 1041.





Manufacturer: Welch Allyn Inc.95 Old Shoals RoadArden , NC 28704USA

Manufacturing site: Speidel+Keller GmbH & CoKGWelch AllynZollerstr. 2 – 4D – 72417 Jungingen



Model: Tenso 24 with Art.No 50-67-189, 50-71-189

Name: Electronical Sphygmomanometer 24 h long term measurement device.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class II under rule 1 of Annex II Point 3. of this directive.In support of this Directive, these products conform the following standards.

EN 1060-3, EN 980 and EN 1041.



Quality Management Signed: Herbert BiermannSpeidel + Keller /Welch Allyn Date: 17.03.1999





Model: Tourniquet system with Art.No. 53-05-124, 53-06-124,

Name: Tourniquet pressure system with cuff, valve and accessories.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14. June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class II under rule 1 of Annex II Point 3. of this directive.In support of this Directive, these products conform all standards about pressure systems.








Model: Pressure infusion cuff Art.No.51-08-040

Name: Cuff included manometer to control the pressure of the intravenous infusion.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14. June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class I under rule 1 of Annex V of this directive.In support of this Directive, these products conform all standards about infusion cuff systems.

The quality system that controls the manufacture and design of this product complies with thefollowing standards, EN ISO 9001: 1994, and EN 46001: 1993. The National Nodyfied BodyTÜV Product Service has authorised the application in conjunction with the CE marking ofconformance applied of this product family.







Model: Sanipress Art.No. 50-09-184, 50-09-284, 50-09-984

Name: Pressure device with cuff, valve and accessories.

Is in conformity with the provisions of Council Directive 93/42/EEC of 14. June 1993, concerningMedical Devices, which apply to them. Following the provisions of this Directive, these productsare classified as Class I under rule 1 of Annex V of this directive.In support of this Directive, these products conform all standards about pressure devices.

The quality system that controls the manufacture and design of this product complies with thefollowing standards, EN ISO 9001: 1994, and EN 46001: 1993. The National Nodyfied BodyTÜV Product Service has authorised the application in conjunction with the CE marking ofconformance applied of this product family.


Quality Management Signed: Herbert BiermannSpeidel + Keller Welch Allyn Date: 14.02.2000






Model Number: 6100-200, 6100-200R, 6100-210, 6100-210R

Name: ABPM 6100, Ambulatory Blood Pressure Monitor

Is in conformity with the provisions of Council Directive 93/42/EEC of 14 June 1993, concerning Medical Devices which apply to them. In support of this directive, these products conform to the following standards:

EN 60601-1-2:1993, EN 1441:1994, EN 1041:1994, EN 980:1994, Council Directive 80/181/EEC plus amendments.

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class II a under rule 10 of Annex IX of this Directive.

Notified Body is the National Standards Authority of Ireland. Reference application number 252.169.


Declaration of ConformityNumber : DOCM113a





Model Number: 6100-10, 6100-11, 6100-12, 6100-13, 6100-14

Name: ABPM 6100, Ambulatory Blood Pressure Monitor Accesories


EN 60601-1, EN 1441, EN 1041, EN 980

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class I under rules #1 and #12 of Annex IX of this Directive.





Address: Navan Business Park Dublin Road,Navan,County Meath,



Model Number: 715 Series

Name: Humphrey Matrix


EN 475, EN 980, EN 1041, EN 14971, EN 15004, EN 60601-1, EN 60601-1-1,EN 60601-1-2, EN 60601-1-4, EN 60825-1, and IEC 60417-1 (Pt. 1 and 2)

Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class I under rule 12 of Annex IX of this Directive.

Notified Body is the National Standards Authority of Ireland.

Sr. Regulatory Affairs Manager Signed: Welch Allyn Inc. Date: August 20, 2003

Declaration of Conformity DOCM115

Manufacturer: Welch Allyn GmbH & CO. KGZollerstr. 2-4

D – 72417 Jungingen

Representative: European Regulatory Manager Welch Allyn GmbH D- 72417 Jungingen

Tel: ++49 747792710 Fax: ++49 7477927190

We Welch Allyn GmbH declare under our sole responsibility that the Product

Model: DS44 WA Part No : DS44-09; DS44-09C; DS44-09CV; DS44-09CVW; DS44-09CW;

DS44-09P; DS44-09PC; DS44-09PCV; DS44-09PCVW; DS44-09PCW; DS44-09PV; DS44-09PVW; DS44-09V; DS44-09VW; DS44-09W; DS44-09PW; DS44-10; DS44-10C; DS44-10CV;

DS44-10CVW; DS44-10CW; DS44-10V; DS44-10VW; DS44-10W; DS44-11; DS44-11C; DS44-11CN; DS44-11CV; DS44-11CVW; DS44-11CW; DS44-11V; DS44-11VW; DS44-11W; DS44-12; DS44-12C; DS44-12CV; DS44-12CVW; DS44-12CW; DS44-12V; DS44-12VW; DS44-12W,

Model: DS45 WA Part No: DS45-09; DS45-09C; DS45-09CE; DS45-09CW; DS45-09CWE;

DS45-09E; DS45-09P; DS45-09PC; DS45-09PCE; DS45-PCW; DS45-09PCWE; DS45-09PE; DS45-09PW; DS45-09PWE; DS45-09W; DS45-09WE; DS45-10; DS45-10C; DS45-10CE; DS45-10CW; DS45-10CWE; DS45-10E; DS45-10W; DS45-10WE; DS45-11; DS45-11C; DS45-11CE; DS45-11CW; DS45-11CWE; DS45-11E; DS45-11W; DS45-11WE; DS45-12; DS45-12C; DS45-12CE; DS45-12CW; DS45-12CWE; DS45-12E; DS45-12W; DS45-12WE,

Model: DS54 Economy WA Part No: DS-5401-300, DS-5401-189, DS-5401-189CB

Model: DS54 Home Economy WA Part No: DS-5401-300, DS-5401-187,

WA Part No: DS-5501-300, DS-5541-300, DS-5521-300, DS-5561-300, DS-5501-189, DS-5501-189CB, DS-5561-169, DS-5502-300, DS-5502-189, DS-5502-189CB

Model: DS56 Standard WA Part No: DS-5601-300, DS-5601-189, DS-5601-189CB, DS-5602-300,

DS-5602-189, DS-5602-189CB

DOCM113 Mechanical Sphygmomanometer D

Name: Mechanical Sphygmomanometer

is in conformity with the provisions of Council Directive 93/42/EEC of 14.June 1993, concerning Medical Devices, which apply to them. Following the provisions of thisDirective, these products are classified as Class I with measurment function under rule 1 of Annex V of this directive. In support of this Directive, these products conform the following standards.

EN 60601-1, EN 1060-1, EN 1060-2, EN 980 and EN 1041.

The quality system that controls the manufacture and design of this product complies with the following standards, EN ISO 9001:1994, and EN 13485:1996. The National Nodyfied Body TÜV Product Service has authorised the application of their Nodyfied Body number 0123 in conjunction with the CE marking of conformance applied of this product family.


Quality & Regulatory Management Signed: Bernd Koehler Welch Allyn GmbH & Co.KG Date: 01.01.2004

830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 1 of 16

Manufacturer Welch Allyn Protocol, Inc.8500 SW Creekside Place Beaverton, OR 97008 USA

Welch Allyn Protocol, Inc. declares under its sole responsibility that the physiological signs monitors, models Propaq 102, 104, 106, 102EL, 104EL, 106EL, printer option, SpO2 option, CO2 option, Hewlett-Packard patient connector option, and associated accessories (see attached list), conform to Annex 1 of Medical Device Directive 93/42/EEC, and other applicable standards.

Welch Allyn Protocol, Inc. has a certified Quality System according to ISO EN 9001:1994, EN 46001:1996 and Annex II.3 of council directive 93/42/EEC by TÜV Product Service 0123.

Classification Annex IX, Rule 10, Class IIb

Device Propaq physiological signs monitor

Models Propaq 102, 104, 106, 102EL, 104EL, 106EL

Applied Standards EN 60601-1:1990, 2nd Edition, A1:1992, A2:1995

Medical Electrical Equipment, Part 1: General Requirements for Safety

EN 60601-1-1:1993 Medical Electrical Equipment, Part 1: General Requirements for Safety, Collateral Standard: Safety Requirements for medical electrical systems

EN 60601-1-2:1993, 1st

Edition (Class B) Medical Electrical Equipment, Part 2: Collateral Standard: Electromagnetic Compatibility: Requirements and Test

DIN 40 839 Teil 1 Electromagnetic Compatibility (EMC) in Road Vehicles

EN60601-2-27: 1994, 1st Edition

Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Electrocardiographic Monitoring Equipment

IEC 601-2-30:1995 Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment

EN 60601-2-34:1995 Medical Electrical Equipment, Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment

EN 864:1996 Medical Electrical Equipment–Capnometers for use with humans–Particular requirements

ISO 9919: 1992E Pulse oximeters for medical use–Requirements

European Regulatory Representative: Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany

Beaverton, OR-USASeptember 2001 ______________________________________

Don M. Abbey, VP of Quality Systems

8500 S. W. CREEKSIDE PLACE BEAVERTON, OREGON 97008-7107 (503) 526-8500 (800) 289-2500 FAX: (503) 526-420

DECLARATION OF CONFORMITY

Page 2 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series

Part Number Description Classification ECG/EKG Accessories

008-0315-00 ECG, 3 Lead Cable, attached lead wires, snap Class I 008-0315-01 ECG, 3 Lead Cable, attached lead wires, snap (IEC) Class I 008-0316-00 ECG, 3 Lead Cable, DIN Class I 008-0316-01 ECG, 3 Lead Cable, DIN (IEC) Class I 008-0321-00 ECG, 3 Lead Wire Set, DIN, adult pinch Class I 008-0321-01 ECG, 3 Lead Wire Set, DIN, adult pinch (IEC) Class I 008-0317-00 ECG, 3 Lead Wire Set, DIN, neonatal pinch Class I 008-0317-01 ECG, 3 Lead Wire Set, DIN, neonatal pinch (IEC) Class I 008-0323-00 ECG, 3 Lead Wire Set, DIN, snap Class I 008-0323-01 ECG, 3 Lead Wire Set, DIN, snap (IEC) Class I 008-0429-00 ECG, 3 Lead Cable, DIN, right angle (AHA/IEC) Class I

NIBP Disposable Cuffs 008-0223-00 Adult Cuff Class I 008-0616-00 Adult Small Cuff, 17-25 cm Class I 008-0617-00 Adult Standard Cuff, 23-33 cm Class I 008-0618-00 Adult Large Cuff, 31-40 cm Class I 008-0222-00 Adult Large Class I 008-0619-00 Adult Thigh Cuff, 38-50 cm Class I

NIBP Reusable Cuffs 008-0629-00 Adult Large Cuff, 31-40 cm Class I 008-0627-00 Adult Small Cuff, 17-25 cm Class I 008-0628-00 Adult Standard Cuff, 23-33 cm Class I 008-0630-00 Adult Thigh Cuff, 38-50 cm Class I 008-0626-00 Child Cuff, 12-19 cm Class I 008-0324-00 Cuff Kit, one each of Large Adult, Small Adult and Thigh Cuff Class I 008-0005-98 Adult Large Cuff, 33-47 cm Class I 008-0007-98 Adult Small Cuff, 18-26 cm Class I 008-0006-98 Adult Standard Cuff, 25-35 cm Class I 008-0008-98 Adult Thigh Cuff, 46-66 cm Class I 008-0011-98 Child Cuff, 18-26 cm Class I 008-0105-98 Cuff Kit, one each of Large Adult, Small Adult and Thigh Cuff Class I

Power Adapters 503-0054-01 AC Adapter Universal, International 200-240 VAC, 50 Hz Class I

CO2 Accessories 008-0502-00 Mainstream CO2 Sensor II and Airway Adapter Set Class IIb 008-0132-00 Adult/Pediatric Airway Adapter (Single Patient Use) Class I 008-0263-00 Low-Deadspace Airway Adapter (Single Patient Use) Class I 008-0261-00 Adult/Pediatric Airway Adapter (Multi Use) Class I 008-0367-00 Adult/Pediatric Airway Adapter (Single Patient Use) Class I 008-0370-00 Water Trap, Sidestream (10/box) Class I 008-0371-00 Water Trap, Sidestream (24/box) Class I


Deutsch

Der Hersteller Welch Allyn Protocol, Inc.8500 SW Creekside Place Beaverton, OR 97008 USA

Welch Allyn Protocol, Inc. erklärt unter seiner alleinigen Verantwortung, dass der Vitalzeichenmonitore, Propaq 102, 104, 106, 102EL, 104EL, 106EL, Druckeroption, SpO2 Option, CO2 Option, Hewlett-Packard Patientenanschlußoption und das zugehörige Zubehör (siehe beiliegende Liste) den Anforderungen von Anhang 1 der Medizingeräterichtlinie 93/42/EWG, und anderer geltenden Normen entspricht.

Welch Allyn Protocol, Inc. hat ein vom TÜV-Produktservice 0123 zertifiziertes Qualitätssicherungssystem nach ISO EN 9001:1994, EN 46001:1996 und Anhang II.3 der Richtlinie des Rates 93/42/EWG.

Klassifizierung Anhang IX, R. 10, Klasse IIb

Gerät Vitalzeichenmonitore Propaq

Models Propaq 102, 104, 106, 102EL, 104EL, 106EL

Angewandte NormenEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Medizinische elektrische Geräte, Teil 1: Allgemeine Festlegungen für die Sicherheit.

EN 60601-1-1:1993 Medizinische elektrische Geräte, Teil 1: Allgemeine Festlegungen für die Sicherheit, Begleitende Norm: Sicherheitsanforderungen für elektrische Medizingerätesysteme

EN 60601-1-2:1993, 1st

Ed. (Klasse B) Medizinische elektrische Geräte, Teil 2: Begleitende Norm: Elektromagnetische Verträglichkeit: Anforderungen und Prüfverfahren.

DIN 40 839 Teil 1 Elektromagnetische Verträglichkeit (EMV) in Kraftfahrzeugen

EN60601-2-27: 1994, 1st Ed.

Medizinische elektrische Geräte, Teil 2: Besondere Anforderungen für die Sicherheit von Elektrokardiographie-Überwachungsgeräten.

IEC 601-2-30:1995 Medizinische elektrische Geräte, Teil 2: Besondere Festlegungen für die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von automatischen, zyklischen, nicht-invasiven Blutdrucküberwachungsgeräten.

EN 60601-2-34:1995 Medizinische elektrische Geräte, Teil 2-34: Besondere Festlegungen für die Sicherheit, einschließlich grundlegender Leistungsmerkmale, von invasiven Blutdruck-Überwachungsgeräten.

EN 864:1996 Medizinische elektrische Geräte– Kapnometer für die Anwendung am Menschen – Besondere Anforderungen

ISO 9919: 1992E Pulsoximeter für medizinische Anwendungen -- Anforderungen

Vertretung für europäische Norm- und Rechtskonformität

Medical Product Service GmBH Borngasse 20 35619 Braunfels, Germany




Artikelummer Beschreibung Klassifikation EKG-Zubehör

008-0315-00 EKG, Kabel mit 3 Ableitungen, angebrachte Elektrodenkabel, Schnappverbindung

Klasse I

008-0315-01 EKG, Kabel mit 3 Ableitungen, angebrachte Elektrodenkabel, Schnappverbindung (IEC)

Klasse I

008-0316-00 EKG, Kabel mit 3 Ableitungen, DIN Klasse I 008-0316-01 EKG, Kabel mit 3 Ableitungen, DIN (IEC) Klasse I 008-0321-00 EKG, Kabelset mit 3 Ableitungen, DIN, Klemme Erwachsene Klasse I 008-0321-01 EKG, Kabelset mit 3 Ableitungen, DIN, Klemme Erwachsene (IEC) Klasse I 008-0317-00 EKG, Kabelset mit 3 Ableitungen, DIN, Klemme Neugeborene Klasse I 008-0317-01 EKG, Kabelset mit 3 Ableitungen, DIN, Klemme Neugeborene (IEC) Klasse I 008-0323-00 EKG, Kabelset mit 3 Ableitungen, DIN, Schnappverbindung Klasse I 008-0323-01 EKG, Kabelset mit 3 Ableitungen, DIN, Schnappverbindung (IEC) Klasse I 008-0429-00 EKG, Kabel mit 3 Ableitungen, DIN, rechtwinklig (AHA/IEC) Klasse I

NIBP Einmal-Manschetten 008-0223-00 Manschette für Erwachsene Klasse I 008-0616-00 Kleine Manschette für Erwachsene, 17-25 cm Klasse I 008-0617-00 Standard-Manschette für Erwachsene, 23-33 cm Klasse I 008-0618-00 Große Manschette für Erwachsene, 31-40 cm Klasse I 008-0222-00 Erwachsene, groß Klasse I 008-0619-00 Oberschenkelmanschette für Erwachsene, 38-50 cm Klasse I

Wiederverwendbare NIBP-Manschetten 008-0629-00 Große Manschette für Erwachsene, 31-40 cm Klasse I 008-0627-00 Kleine Manschette für Erwachsene, 17-25 cm Klasse I 008-0628-00 Standard-Manschette für Erwachsene, 23-33 cm Klasse I 008-0630-00 Oberschenkelmanschette für Erwachsene, 38-50 cm Klasse I 008-0626-00 Manschette für Kinder, 12-19 cm Klasse I

008-0324-00 Manschettenset, je eine Erwachsene, groß, Erwachsene, klein, und Oberschenkelmanschette

Klasse I

008-0005-98 Große Manschette für Erwachsene, 33-47 cm Klasse I 008-0007-98 Kleine Manschette für Erwachsene, 18-26 cm Klasse I 008-0006-98 Standard-Manschette für Erwachsene, 25-35 cm Klasse I 008-0008-98 Oberschenkelmanschette für Erwachsene, 46-66 cm Klasse I 008-0011-98 Manschette für Kinder, 18-26 cm Klasse I

008-0105-98 Manschettenset, je eine Erwachsene, groß, Erwachsene, klein, und Oberschenkelmanschette

Klasse I

Netzteile503-0054-01 Wechselstrom-Netzteil Universal, International 200-240 VAC, 50 Hz Klasse I

CO2 Zubehör 008-0502-00 Hauptstrom-CO2- Sensor II und Luftweg-Adapterset Klasse IIb 008-0132-00 Luftweg-Adapterset für Erwachsene/Kinder (eins pro Patient verwenden) Klasse I 008-0263-00 Luftweg- Adapter mit geringem Totraum (einen pro Patient verwenden) Klasse I 008-0261-00 Luftweg-Adapterset für Erwachsene/Kinder (mehrfach verwendbar) Klasse I 008-0367-00 Luftweg- Adapter für Erwachsene/Kinder (einen pro Patient verwenden) Klasse I 008-0370-00 Wasserfalle, Nebenstrom (10/Packung) Klasse I 008-0371-00 Wasserfalle, Nebenstrom (24/ Packung) Klasse I


Español

Fabricante

Welch Allyn Protocol, Inc. declara, bajo su responsabilidad, que los modelos Monitores de signos fisiológicos Propaq 102, 104, 106, 102EL, 104EL, 106EL, opción de impresora, opción SpO2, opción CO2, opción de conector para el paciente Hewlett-Packard, y los accesorios asociados (véase la lista adjunta), cumplen lo establecido en el Anexo 1 de la directiva 93/42/EEC respecto a dispositivos médicos, y otros estándares aplicables.

Welch Allyn Protocol, Inc. tiene un Sistema de Calidad certificado de acuerdo con la ISO EN 9001:1994, EN 46001:1996 y Anexo II.3 de la Directiva del Consejo 93/42/EEC de TÜV Product Service 0123.

Clasificación Anexo IX, R. 10, Clase IIb

Dispositivo Monitores de signos fisiológicos Propaq

Modelo(s) Propaq 102, 104, 106, 102EL, 104EL, 106EL

Normas aplicadasEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Equipos electromédicos, 1ª parte: Requisitos generales de seguridad.

EN 60601-1-1:1993 Equipos electromédicos, 1ª parte: Requisitos generales de seguridad, Collateral Standard: Safety Requirements for medical electrical systems.

EN 60601-1-2:1993, 1st

Ed. (Clase B) Equipos electromédicos, 2ª parte: Norma colateral: Compatibilidad electromagnética: requisitos y ensayos.

DIN 40 839 Teil 1 Compatibilidad electromagnética (CEM) en vehículos.

EN60601-2-27: 1994, 1st Ed.

Equipos electromédicos, 2ª parte: Requisitos particulares para la seguridad de equipos de monitorización electrocardiográfica.

IEC 601-2-30:1995 Equipos electromédicos, 2ª parte: Requisitos particulares para la seguridad de equipos de monitorización de la presión sanguínea, de funcionamiento automático, cíclico e indirecto.

EN 60601-2-34:1995 Equipos electromédicos, 2-34 parte: Requisitos particulares para la seguridad, incluyendo el funcionamiento básico, de equipos de monitorización de la presión sanguínea

EN 864:1996 Equipos electromédicos – Capnómetros para uso en humanos – Requisitos particulares

ISO 9919: 1992E Requisitos de los oxímetros de pulso para uso médico

Representante para la conformidad con la normativa europea

Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany

Beaverton, OR-USASeptiembre 2001 ______________________________________



Referencia Descripción Clasificación Accesorios ECG/EKG

008-0315-00 ECG, cable de 3 electrodos, electrodos conectados a presión Clase I 008-0315-01 ECG, cable de 3 electrodos, electrodos conectados a presión (CEI) Clase I 008-0316-00 ECG, cable de 3 electrodos, DIN Clase I 008-0316-01 ECG, cable de 3 electrodos, DIN (CEI) Clase I 008-0321-00 ECG, juego de 3 electrodos, DIN, pinza adulto Clase I 008-0321-01 ECG, juego de 3 electrodos, DIN, pinza adulto (CEI ) Clase I 008-0317-00 ECG, juego de 3 electrodos, DIN, pinza neonatal Clase I 008-0317-01 ECG, juego de 3 electrodos, DIN, pinza neonatal (CEI) Clase I 008-0323-00 ECG, juego de 3 electrodos, DIN, a presión Clase I 008-0323-01 ECG, juego de 3 electrodos, DIN, a presión (CEI) Clase I 008-0429-00 ECG, cable de 3 electrodos, DIN, ángulo recto (AHA/CEI) Clase I

Manguitos desechables NIBP 008-0223-00 Manguito adulto Clase I 008-0616-00 Manguito adulto pequeño, 17-25 cm Clase I 008-0617-00 Manguito adulto estándar, 23-33 cm Clase I 008-0618-00 Manguito adulto grande, 31-40 cm Clase I 008-0222-00 Adulto grande Clase I 008-0619-00 Manguito adulto para muslo, 38-50 cm Clase I

Manguitos reutilizables NIBP 008-0629-00 Manguito adulto grande, 31-40 cm Clase I 008-0627-00 Manguito adulto pequeño, 17-25 cm Clase I 008-0628-00 Manguito adulto estándar, 23-33 cm Clase I 008-0630-00 Manguito adulto para muslo, 38-50 cm Clase I 008-0626-00 Manguito infantil, 12-19 cm Clase I 008-0324-00 Equipo de manguitos, de adulto grande, pequeño y para muslo, uno de cada Clase I 008-0005-98 Manguito adulto grande, 33-47 cm Clase I 008-0007-98 Manguito adulto pequeño, 18-26 cm Clase I 008-0006-98 Manguito adulto estándar, 25-35 cm Clase I 008-0008-98 Manguito adulto para muslo, 46-66 cm Clase I 008-0011-98 Manguito infantil, 18-26 cm Clase I 008-0105-98 Equipo de manguitos, de adulto grande, pequeño y para muslo, uno de cada Clase I

Adaptadores de corriente 503-0054-01 Adaptador de CA internacional universal, 200-240 VCA, 50 Hz Clase I

Accesorios de C02

008-0502-00 Equipo adaptador de sensor II de CO2 de corriente principal y de vía aérea Clase IIb 008-0132-00 Adaptador de vía aérea para adulto/pediátrico (un solo uso) Clase I 008-0263-00 Adaptador de vía aérea para espacio muerto bajo (un solo uso) Clase I 008-0261-00 Adaptador de vía aérea para adulto/pediátrico (reutilizable) Clase I 008-0367-00 Adaptador de vía aérea para adulto/pediátrico (un solo uso) Clase I 008-0370-00 Colector de agua, corriente secundaria (10/caja) Clase I 008-0371-00 Colector de agua, corriente secundaria (24/caja) Clase I


Français

Fabricant Welch Allyn Protocol, Inc. 8500 SW Creekside Place Beaverton, OR 97008

Welch Allyn Protocol, Inc. déclare sous sa seule responsabilité que Moniteur des signes physiologiques Propaq 102, 104, 106, 102EL, 104EL, 106EL, option imprimante, option SpO2, option CO2, option connecteur patient Hewlett-Packard et les accessoires associés (voir liste jointe), sont conformes à l'Annexe 1 de la Directive relative aux appareils médicaux 93/42/EEC, et aux autres normes applicables.

Welch Allyn Protocol, Inc. possède un Système Qualité certifié conformément à ISO EN 9001:1994, EN 46001:1996 et à l'Annexe II.3 de la directive du conseil 93/42/EEC de TÜV Product Service 0123.

Classification Annexe IX, R. 10, Classe IIb

Appareil Moniteur des signes physiologiques Propaq

Modèles Propaq 102, 104, 106, 102EL, 104EL, 106EL

Normes appliquéesEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Matériel électrique médical, 1ère partie : Exigences générales de sécurité.

EN 60601-1-1:1993 Matériel électrique médical, 1ère partie : Exigences générales de sécurité, Norme collatérale : Exigences de sécurité pour les systèmes électriques médicaux

EN 60601-1-2:1993, 1st

Ed. (Classe B) Matériel électrique médical, 2 partie : Norme collatérale : Compatibilité électromagnétique : Exigences et test.

DIN 40 839 Teil 1 Compatibilité électromagnétique (EMC) dans les véhicules de transport

EN60601-2-27: 1994, 1st Ed.

Matériel électrique médical, 2 partie : Exigences particulières pour la sécurité du matériel de surveillance électrocardiographique.

IEC 601-2-30:1995 Matériel électrique médical, 2 partie : Exigences particulières pour la sécurité du matériel de surveillance de la pression artérielle indirect à cycles automatiques

EN 60601-2-34:1995 Matériel électrique médical, 2-34 partie: Exigences particulières de sécurité, y compris les performances essentielles, du matériel de surveillance de la pression artérielle invasive

EN 864:1996 Matériel électrique médical – Capnomètres à usage humain – Exigences particulières

ISO 9919: 1992E Oxymètres de pulsations à usage médical --Exigences

Conseiller en législation européenne Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany

Beaverton, OR-USASeptembre 2001 ______________________________________



Référence Description Classification Accessoires ECG/EKG

008-0315-00 ECG, Câble 3 dérivations, fils de dérivations attachés, cliquet Classe I 008-0315-01 ECG, Câble 3 dérivations, fils de dérivations attachés, cliquet (IEC) Classe I 008-0316-00 ECG, Câble 3 dérivations, DIN Classe I 008-0316-01 ECG, Câble 3 dérivations, DIN (IEC) Classe I 008-0321-00 ECG, Ensemble câble 3 dérivations, DIN, pince adulte Classe I 008-0321-01 ECG, Ensemble câble 3 dérivations, DIN, pince adulte (IEC) Classe I 008-0317-00 ECG, Ensemble câble 3 dérivations, DIN, pince nouveau-né Classe I 008-0317-01 ECG, Ensemble câble 3 dérivations, DIN, pince nouveau-né (IEC) Classe I 008-0323-00 ECG, Ensemble câble 3 dérivations, DIN, cliquet Classe I 008-0323-01 ECG, Ensemble câble 3 dérivations, DIN, cliquet (IEC) Classe I 008-0429-00 ECG, Câble 3 dérivations, DIN, angle droit (AHA/IEC) Classe I

Manchons PSNI jetables 008-0223-00 Manchon adulte Classe I 008-0616-00 Manchon adulte petit, 17 à 25 cm Classe I 008-0617-00 Manchon adulte standard, 23 à 33 cm Classe I 008-0618-00 Manchon adulte grand, 31 à 40 cm Classe I 008-0222-00 Adulte grand Classe I 008-0619-00 Manchon de cuisse adulte, 38 à 50 cm Classe I

Manchons PSNI réutilisables 008-0629-00 Manchon adulte, grand, 31 à 40 cm Classe I 008-0627-00 Manchon adulte petit, 17 à 25 cm Classe I 008-0628-00 Manchon adulte standard, 22 à 33 cm Classe I 008-0630-00 Manchon de cuisse adulte, 38 à 50 cm Classe I 008-0626-00 Manchon enfant, 12 à 19 cm Classe I 008-0324-00 Kit manchon, un de chaque : adulte grand, petit et manchon de cuisse Classe I 008-0005-98 Manchon adulte grand, 33 à 47 cm Classe I 008-0007-98 Manchon adulte petit, 18 à 26 cm Classe I 008-0006-98 Manchon adulte standard, 25 à 35 cm Classe I 008-0008-98 Manchon de cuisse adulte, 46 à 66 cm Classe I 008-0011-98 Manchon enfant, 18 à 26 cm Classe I 008-0105-98 Kit manchon, un de chaque : adulte grand, petit et manchon de cuisse Classe I

Adaptateurs secteur 503-0054-01 Adaptateur CA universel, International 200 à 240 V, 50 Hz Classe I

Accessoires CO2

008-0502-00 Ensemble capteur II CO2 Mainstream et adaptateur circuit d’air Classe IIb 008-0132-00 Adaptateur circuit d’air adulte/pédiatrique (pour un seul patient) Classe I 008-0263-00 Adaptateur circuit d’air à faible volume mort (pour un seul patient) Classe I 008-0261-00 Adaptateur circuit d’air adulte/pédiatrique (réutilisable) Classe I 008-0367-00 Adaptateur circuit d’air adulte/pédiatrique (pour un seul patient) Classe I 008-0370-00 Collecteur d’eau, Sidestream (10/boîte) Classe I 008-0371-00 Collecteur d’eau, Sidestream (24/boîte) Classe I


Italiano

Il produttoreWelch Allyn Protocol, Inc. 8500 SW Creekside Place Beaverton, OR 97008

Welch Allyn Protocol, Inc. dichiara, sotto propria esclusiva responsabilità, che il Monitor segni fisiologici, Propaq 102, 104, 106, 102EL, 104EL, 106EL, opzione stampante, opzione SpO2, opzione CO2, opzione connettore paziente Hewlett-Packard, e i relativi accessori (vedere elenco allegato), sono conformi all'Allegato 1 della Direttiva sui dispositivi medici 93/42/EEC, e ad altri standard applicabili.

Welch Allyn Protocol, Inc. dispone di un Sistema di controllo della qualità conforme agli standard ISO EN 9001:1994, EN 46001:1996 e all'Allegato II.3 della direttiva comunitaria 93/42/EEC, certificato da TÜV Product Service 0123.

Classificazione Allegato IX, R. 10, Classe IIb

Dispositivo Monitor segni fisiologici, Propaq

Modello del prodotto Propaq 102, 104, 106, 102EL, 104EL, 106EL

Standard applicati EN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Apparecchiatura elettromedicale, parte 1: Requisiti generali per la sicurezza

EN 60601-1-1:1993 Apparecchiatura elettromedicale, parte 1: Requisiti generali per la sicurezza, Collateral Standard: Safety Requirements for medical electrical systems

EN 60601-1-2:1993, 1st

Ed. (Classe B) Apparecchiatura elettromedicale, parte 2: Standard collaterale: Compatibilità elettromagnetica: Requisiti e collaudo

DIN 40 839 Teil 1 Compatibilità elettromagnetica (EMC, Electromagnetic Compatibility) nei veicoli stradali

EN60601-2-27: 1994, 1st Ed.

Apparecchiatura elettromedicale, parte 2: Requisiti specifici per la sicurezza di attrezzature di monitoraggio elettrocardiografico

IEC 601-2-30:1995 Apparecchiatura elettromedicale, parte 2: Requisiti specifici per la sicurezza di attrezzature per il monitoraggio indiretto della pressione sanguigna a ciclo automatico

EN 60601-2-34:1995 Apparecchiatura elettromedicale, parte 2-34: Requisiti specifici per la sicurezza, comprese le prestazioni essenziali, di attrezzature per il monitoraggio invasivo della pressione sanguigna

EN 864:1996 Apparecchiatura elettromedicale– Capnometri per l'uso in pazienti umani – Requisiti specifici

ISO 9919: 1992E Pulsossimetri per uso medico--requisiti

Rappresentante per la conformità prodotti alle normative europee


Beaverton, OR-USASettembre 2001 ______________________________________



Numero parte Descrizione Classificazione Accessori ECG/EKG

008-0315-00 ECG, cavo a 3 derivazioni, cavi collegati, fermo Classe I 008-0315-01 ECG, cavo a 3 derivazioni, cavi collegati, fermo (IEC) Classe I 008-0316-00 ECG, cavo a 3 derivazioni, DIN Classe I 008-0316-01 ECG, cavo a 3 derivazioni, DIN (IEC) Classe I 008-0321-00 ECG, kit cavo a 3 derivazioni, DIN, pinza per adulti Classe I 008-0321-01 ECG, kit cavo a 3 derivazioni, DIN, pinza per adulti (IEC) Classe I 008-0317-00 ECG, kit cavo a 3 derivazioni, DIN, pinza per nenonati Classe I 008-0317-01 ECG, kit cavo a 3 derivazioni, DIN, pinza per neonati (IEC) Classe I 008-0323-00 ECG, kit cavo a 3 derivazioni, DIN, fermo Classe I 008-0323-01 ECG, kit cavo a 3 derivazioni, DIN, fermo (IEC) Classe I 008-0429-00 ECG, cavo a 3 derivazioni, DIN, ad angolo retto (AHA/IEC) Classe I

Manicotti monouso NIBP 008-0223-00 Manicotto per adulti Classe I 008-0616-00 Manicotto piccolo per adulti, 17-25 cm Classe I 008-0617-00 Manicotto standard per adulti, 23-33 cm Classe I 008-0618-00 Manicotto grande per adulti, 31-40 cm Classe I 008-0222-00 Grande per adulti Classe I 008-0619-00 Manicotto femorale per adulti, 38-50 cm Classe I

Manicotti riutilizzabili NIBP 008-0629-00 Manicotto grande per adulti, 31-40 cm Classe I 008-0627-00 Manicotto piccolo per adulti, 17-25 cm Classe I 008-0628-00 Manicotto standard per adulti, 23-33 cm Classe I 008-0630-00 Manicotto femorale per adulti, 38-50 cm Classe I 008-0626-00 Manicotto per bambini, 12-19 cm Classe I

008-0324-00 Kit manicotti, uno grande per adulti, uno piccolo per adulti e un manicotto femorale

Classe I

008-0005-98 Manicotto grande per adulti, 33-47 cm Classe I 008-0007-98 Manicotto piccolo per adulti, 18-26 cm Classe I 008-0006-98 Manicotto standard per adulti, 25-35 cm Classe I 008-0008-98 Manicotto femorale per adulti, 46-66 cm Classe I 008-0011-98 Manicotto per bambini, 18-26 cm Classe I

008-0105-98 Kit manicotto, uno grande per adulti, uno piccolo per adulti e un manicotto femorale

Classe I

Adattatori di alimentazione 503-0054-01 Adattatore CA universale, internazionale 200/240 V CA, 50Hz Classe I

Accessori CO2

008-0502-00 Set sensore II CO2 Mainstream e adattatore vie aeree Classe IIb 008-0132-00 Adattatore vie aeree Adulto/Pediatrico (utilizzabile con un singolo paziente) Classe I 008-0263-00 Adattatore vie aeree a ingombro ridotto (utilizzabile con un singolo paziente) Classe I 008-0261-00 Adattatore vie aeree adulto/pediatrico (utilizzabile con più pazienti) Classe I 008-0367-00 Adattatore vie aeree adulto/pediatrico (utilizzabile con un singolo paziente) Classe I 008-0370-00 Filtro acqua, Sidestream (confezione da 10) Classe I 008-0371-00 Filtro acqua, Sidestream (confezione da 24) Classe I


Nederlands

Wij, Producent, Welch Allyn Protocol, Inc. 8500 SW Creekside Place Beaverton, OR 97008

Welch Allyn Protocol, Inc. verklaart als enige verantwoordelijke dat de Monitor voor Fysiologische levenstekens, Propaq 102, 104, 106, 102EL, 104EL, 106EL, printeroptie, SpO2-optie, CO2-optie, Hewlett-Packard patiëntconnector-optie, en de bijbehorende accessoires (zie bijgevoegde lijst) voldoen aan Bijlage 1 van Richtlijn 93/42/EEG betreffende medische hulpmiddelen, en andere van toepassing zijnde normen.

Welch Allyn Protocol, Inc. bezit een gecertificeerd kwaliteitssysteem in overeenstemming met ISO EN 9001:1994, EN 46001:1996 en Bijlage II.3 van Richtlijn 93/42/EEG van TÜV Product Service 0123.

Classificatie Bijlage IX, R. 10, Klasse IIb

Apparaat Monitor voor Fysiologische levenstekens, Propaq

Modellen Propaq 102, 104, 106, 102EL, 104EL, 106EL

Toegepaste normenEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Elektromedische apparatuur, deel 1: algemene veiligheidseisen

EN 60601-1-1:1993 Elektromedische apparatuur, deel 1: algemene veiligheidseisen, Collaterale norm: Veiligheidseisen voor elektromedische apparatuur

EN 60601-1-2:1993, 1st

Ed. (Klasse B) Elektromedische apparatuur, deel 2: Collaterale norm - elektromagnetische compatibiliteit: vereisten en test

DIN 40 839 Teil 1 Elektromagnetische compatibiliteit (EMC)

EN60601-2-27: 1994, 1st Ed.

Elektromedische apparatuur, deel 2: Specifieke eisen voor de veiligheid van elektrocardiografische meetapparatuur

IEC 601-2-30:1995 Elektromedische apparatuur, deel 2: Specifieke eisen voor de veiligheid van indirecte bloeddrukmeetapparatuur met automatische cyclus

EN 60601-2-34:1995 Elektromedische apparatuur, deel 2-34: Specifieke eisen voor de veiligheid, met inbegrip van essentiële prestaties, van invasieve bloeddrukmeetapparatuur

EN 864:1996 Elektromedische apparatuur– Capnometers voor gebruik bij mensen – Specifieke eisen

ISO 9919: 1992E Pulse-oximeters voor medisch gebruik - eisen

Vertegenwoordiger inzake naleving Europese regelgeving





Artikel nummer

Beschrijving Classificatie

ECG/EKG-accessoires 008-0315-00 ECG, 3-leadkabel, aangekoppelde leaddraden, kliksysteem Klasse I 008-0315-01 ECG, 3-leadkabel, aangekoppelde leaddraden, kliksysteem (IEC) Klasse I 008-0316-00 ECG, 3-leadkabel, DIN Klasse I 008-0316-01 ECG, 3-leadkabel, DIN (IEC) Klasse I 008-0321-00 ECG, 3-leaddraad set, DIN, klem voor volwassenen Klasse I 008-0321-01 ECG, 3-leaddraad set, DIN, klem voor kinderen (IEC) Klasse I 008-0317-00 ECG, 3-leaddraad set, DIN, klem voor neonati Klasse I 008-0317-01 ECG, 3-leaddraad set, DIN, klem voor neonati (IEC) Klasse I 008-0323-00 ECG, 3-leaddraad set, DIN, kliksysteem Klasse I 008-0323-01 ECG, 3-leaddraad set, DIN, kliksysteem (IEC) Klasse I 008-0429-00 ECG, 3-leadkabel, DIN, rechte hoek (AHA/IEC) Klasse I

Disposable NIB-manchetten 008-0223-00 Manchet voor volwassene Klasse I 008-0616-00 Kleine manchet volwassene, 17-25 cm Klasse I 008-0617-00 Standaardmanchet voor volwassene, 23-33 cm Klasse I 008-0618-00 Grote manchet voor volwassene, 31-40 cm Klasse I 008-0222-00 Grote volwassene Klasse I 008-0619-00 Dijmanchet voor volwassene, 38-50 cm Klasse I

Herbruikbare NIB-manchetten 008-0629-00 Grote manchet voor volwassene, 31-40 cm Klasse I 008-0627-00 Kleine manchet volwassene, 17-25 cm Klasse I 008-0628-00 Standaardmanchet voor volwassene, 23-33 cm Klasse I 008-0630-00 Dijmanchet voor volwassene, 38-50 cm Klasse I 008-0626-00 Manchet voor kind, 12-19 cm Klasse I

008-0324-00 Manchetkit met één Grote manchet voor volwassene, één Kleine manchet volwassene en één Dijmanchet

Klasse I

008-0005-98 Grote manchet voor volwassene, 33-47 cm Klasse I 008-0007-98 Kleine manchet volwassene, 18-26 cm Klasse I 008-0006-98 Standaardmanchet voor volwassene, 25-35 cm Klasse I 008-0008-98 Dijmanchet voor volwassene, 46-66 cm Klasse I 008-0011-98 Manchet voor kind, 18-26 cm Klasse I

008-0105-98 Manchetkit met één Grote manchet voor volwassene, één Kleine manchet volwassene en één Dijmanchet

Klasse I

Netadapters 503-0054-01 Wisselstroomadapter universeel, internationaal 200-240 V, 50 Hz Klasse I

CO2-accessoires 008-0502-00 Mainstream CO2-sensor- II en -luchtwegadapterset Klasse IIb 008-0132-00 Luchtwegadapter voor volwassene/kind (voor gebruik bij één patiënt) Klasse I 008-0263-00 Luchtwegadapter lage dode ruimte (voor gebruik bij één patiënt) Klasse I 008-0261-00 Luchtwegadapter voor volwassene/kind (herbruikbaar) Klasse I 008-0367-00 Luchtwegadapter voor volwassene/kind (voor gebruik bij één patiënt) Klasse I 008-0370-00 Waterzak, Sidestream (10/box) Klasse I 008-0371-00 Waterzak, Sidestream (24/box) Klasse I


Português

Fabricante Welch Allyn Protocol, Inc. 8500 SW Creekside Place Beaverton, OR 97008

Welch Allyn Protocol, Inc. declara sob sua inteira responsabilidade que o Monitor de Sinais Fisiológicos, Propaq 102, 104, 106, 102EL, 104EL, 106EL, opção de impressão, opção SPO2, opção CO2, opção de ligação ao doente Hewlett-Packard, e acessórios associados (consulte lista anexa), estão em conformidade com o Anexo 1 da directiva 93/42/EEC relativa aos dispositivos médicos, e outras normas aplicáveis.

Welch Allyn Protocol, Inc. tem um Sistema de Qualidade certificado de acordo com a ISO EN 9001:1994, EN 46001:1996 e o Anexo II.3 da directiva do conselho 93/42/EEC pelo TÜV Product Service 0123.

Classificação Anexo IX, R. 10, Categoria IIb

Aparelho Monitor de Sinais Fisiológicos, Propaq

Modelos do produto Propaq 102, 104, 106, 102EL, 104EL, 106EL

Normas aplicadasEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Equipamento Médico Eléctrico, Parte 1: Requisitos Gerais Para a Segurança

EN 60601-1-1:1993 Equipamento Médico Eléctrico, Parte 1: Requisitos Gerais Para a Segurança, Norma Colateral: Requisitos de Segurança para sistemas médicos eléctricos

EN 60601-1-2:1993, 1st

Ed. (Categoria B) Equipamento Médico Eléctrico, Parte 2: Norma Colateral: Compatibilidade Electromagnética Requisitos e Teste

DIN 40 839 Teil 1 Compatibilidade Electromagnética (CEM) em Veículos de Estrada

EN60601-2-27: 1994, 1st Ed.

Equipamento Médico Eléctrico, Parte 2: Requisitos Particulares para a Segurança de Equipamento de Monitorização Electrocardiográfico

IEC 601-2-30:1995 Equipamento Médico Eléctrico, Parte 2: Requisitos Particulares para a Segurança de Equipamento de Monitorização de Tensão Arterial Indirecta de Ciclo Automático

EN 60601-2-34:1995 Equipamento Médico Eléctrico, Parte 2-34: Requisitos Particulares para a Segurança, Incluindo Desempenho Essencial, de Equipamento de Monitorização de Tensão Arterial Invasora

EN 864:1996 Equipamento Médico Eléctrico–Capnómetros para utilização com seres humanos–Requisitos Particulares

ISO 9919: 1992E Oxímetros de Pulso para utilização médica—Requisitos

Representante para a Regulamentação Europeia


Beaverton, OR-USASetembro 2001 ______________________________________



Referência Descrição Classificação Acessórios de ECG

008-0315-00 ECG, 3 Cabo de eléctrodo, fios de chumbo ligados, de encaixe Categoria I 008-0315-01 ECG, 3 Cabo de eléctrodo, fios de chumbo ligados, de encaixe (IEC) Categoria I 008-0316-00 ECG, 3 Cabo de eléctrodo, DIN Categoria I 008-0316-01 ECG, 3 Cabo de eléctrodo, DIN (IEC) Categoria I 008-0321-00 ECG, 3 Conjunto de fios de chumbo, DIN, ligação para adulto Categoria I 008-0321-01 ECG, 3 Conjunto de fios de chumbo, DIN, ligação para adulto (IEC) Categoria I 008-0317-00 ECG, 3 Conjunto de fios de chumbo, DIN, ligação neonatal Categoria I 008-0317-01 ECG, 3 Conjunto de fios de chumbo, DIN, ligação neonatal (IEC) Categoria I 008-0323-00 ECG, 3 Conjunto de fios de chumbo, DIN, de encaixe Categoria I 008-0323-01 ECG, 3 Conjunto de fios de chumbo, DIN, de encaixe (IEC) Categoria I 008-0429-00 ECG, 3 Cabo de eléctrodo, DIN, ângulo recto (AHA/IEC) Categoria I

Mangas descartáveis NIBP 008-0223-00 Manga de Adulto Categoria I 008-0616-00 Manga Pequena de Adulto, 17-25 cm Categoria I 008-0617-00 Manga Normal de Adulto, 23-33 cm Categoria I 008-0618-00 Manga Grande de Adulto, 31-40 cm Categoria I 008-0222-00 Adulto Grande Categoria I 008-0619-00 Manga de Adulto para Coxa, 38-50 cm Categoria I

Mangas reutilizáveis NIBP 008-0629-00 Manga Grande de Adulto, 31-40 cm Categoria I 008-0627-00 Manga Pequena de Adulto, 17-25 cm Categoria I 008-0628-00 Manga Normal de Adulto, 23-33 cm Categoria I 008-0630-00 Manga de Adulto Para Coxa, 38-50 cm Categoria I 008-0626-00 Manga de Criança, 12-19 cm Categoria I

008-0324-00 Conjunto de Manga, uma de cada Adulto Grande, Adulto Pequena e Manga Para Coxa

Categoria I

008-0005-98 Manga Grande de Adulto, 33-47 cm Categoria I 008-0007-98 Manga Pequena de Adulto, 18-26 cm Categoria I 008-0006-98 Manga Normal de Adulto, 25-35 cm Categoria I 008-0008-98 Manga de Adulto Para Coxa, 46-66 cm Categoria I 008-0011-98 Manga de Criança, 18-26 cm Categoria I

008-0105-98 Conjunto de Manga, uma de cada Adulto Grande, Adulto Pequena e Manga Para Coxa

Categoria I

Adaptadores de potência 503-0054-01 Adaptador Universal AC, Internacional 200-240 VAC, 50 Hz Categoria I

Acessórios CO2

008-0502-00 Sensor II de CO2 Mainstream e Conjunto de Adaptador de Vias Respiratórias Categoria IIb

008-0132-00 Adaptador de Vias Respiratórias Adulto/Pediátrico (Utilização num Único Doente)

Categoria I

008-0263-00 Adaptador de Vias Respiratórias de Baixo-Espaço Morto (Utilização num Único Doente)

Categoria I

008-0261-00 Adaptador de Vias Respiratórias Adulto/Pediátrico (Multi-usos) Categoria I

008-0367-00 Adaptador de Vias Respiratórias Adulto/Pediátrico (Utilização num Único Doente)

Categoria I

008-0370-00 Colector de Água, Sidestream (10/caixa) Categoria I 008-0371-00 Colector de Água, Sidestream (24/caixa) Categoria I


Svenska

Tillverkare Welch Allyn Protocol, Inc. 8500 SW Creekside Place Beaverton, OR 97008

Welch Allyn Protocol, Inc. försäkrar under eget ansvar att Monitor för fysiologiska tecken, Propaq 102, 104, 106, 102EL, 104EL, 106EL, Skrivartillval, SpO2-tillval, CO2-tillval, Hewlett-Packard patientanslutningstillval och motsvarande tillbehör (se bifogade förteckning), är i överensstämmelse med bilaga 1 till direktiv 93/42/EEC om medicintekniska produkter, samt andra tillämpliga standarder.

Welch Allyn Protocol, Inc. innehar ett av TÜV Product Service 0123 certifierat kvalitetssystem enligt ISO EN 9001:1994, EN 46001:1996 och bilaga II.3 till Rådets direktiv 93/42/EEC.

Klassificering Bilaga IX, R. 10, Klass IIb

Apparat Monitor för fysiologiska tecken, Propaq

Produktmodell Propaq 102, 104, 106, 102EL, 104EL, 106EL

Tillämpade standarderEN 60601-1:1990, 2nd Ed., A1:1992, A2:1995

Elektromedicinsk utrustning, del 1: Allmänna fordringar på säkerhet

EN 60601-1-1:1993 Elektromedicinsk utrustning, del 1: Allmänna fordringar på säkerhet, Tilläggsstandard: Säkerhetsfordringar för elektromedicinska system

EN 60601-1-2:1993, 1st

Ed. (Klass B) Elektromedicinsk utrustning, del 2: Tilläggsstandard: Elektromagnetisk kompatibilitet: Fordringar och provning

DIN 40 839 Teil 1 Elektromagnetisk kompatibilitet (EMC) hos vägfordon

EN60601-2-27: 1994, 1st Ed.

Elektromedicinsk utrustning, del 2: Särskilda fordringar på utrustning för EKG-övervakning

IEC 601-2-30:1995 Elektromedicinsk utrustning, del 2: Särskilda fordringar på utrustning för automatisk repetitiv icke-invasiv bloctrycksövervakning

EN 60601-2-34:1995 Elektromedicinsk utrustning, del 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment

EN 864:1996 Elektromedicinsk utrustning– Kapnometrar för användning hos människa – Särskilda fordringar

ISO 9919: 1992E Pulsoximetrar för medicinsk användning -- fordringar

Ombud för EU-regler





Artikelnummer Beskrivning Klassning EKG-tillbehör

008-0315-00 EKG, 3-elektrodkabel, vidfästa ledningstrådar, snäppfäste Klass I 008-0315-01 EKG, 3-elektrodkabel, vidfästa ledningstrådar, snäppfäste (IEC) Klass I 008-0316-00 EKG, 3-elektrodkabel, DIN Klass I 008-0316-01 EKG, 3-elektrodkabel, DIN (IEC) Klass I 008-0321-00 EKG, set innehållande anslutningskabel för 3-elektrod, DIN, vuxen, klämfäste Klass I

008-0321-01 EKG, set innehållande anslutningskabel för 3-elektrod, DIN, vuxen, klämfäste (IEC)

Klass I

008-0317-00 EKG, set innehållande anslutningskabel för 3-elektrod, neonatal, DIN, klämfäste Klass I

008-0317-01 EKG, set innehållande anslutningskabel för 3-elektrod, neonatal, DIN, klämfäste (IEC)

Klass I

008-0323-00 EKG, set innehållande anslutningskabel för 3-elektrod, DIN, snäppfäste Klass I 008-0323-01 EKG, set innehållande anslutningskabel för 3-elektrod, DIN, snäppfäste (IEC) Klass I 008-0429-00 EKG, 3-elektrodkabel DIN, rätvinklig (AHA/IEC) Klass I

NIBP, engångsmanschetter 008-0223-00 Vuxenmanschett Klass I 008-0616-00 Vuxen, liten manschett, 17-25 cm Klass I 008-0617-00 Vuxen, standardmanschett, 23-33 cm Klass I 008-0618-00 Vuxen, stor manschett, 31-40 cm Klass I 008-0222-00 Vuxen, stor Klass I 008-0619-00 Vuxen, lårmanschett, 38-50 cm Klass I

NIBP, återanvändbara manschetter 008-0629-00 Vuxen, stor manschett, 31-40 cm Klass I 008-0627-00 Vuxen, liten manschett, 17-25 cm Klass I 008-0628-00 Vuxen, standardmanschett, 23-33 cm Klass I 008-0630-00 Vuxen, lårmanschett, 38-50 cm Klass I 008-0626-00 Barn, manschett, 12-19 cm Klass I 008-0324-00 Uppsättning manschetter, en stor vuxen, en liten vuxen, en lårmanschett Klass I 008-0005-98 Vuxen, stor manschett, 33-47 cm Klass I 008-0007-98 Vuxen, liten manschett, 18-26 cm Klass I 008-0006-98 Vuxen, standardmanschett, 25-35 cm Klass I 008-0008-98 Vuxen, lårmanschett, 46-66 cm Klass I 008-0011-98 Barn, manschett, 18-26 cm Klass I 008-0105-98 Uppsättning manschetter, en stor vuxen, en liten vuxen, en lårmanschett Klass I

Nätadapter 503-0054-01 Universaladapter för växelström , internationell, 200-240 V, 50 Hz Klass I

CO2 tillbehör 008-0502-00 Mainstream CO2 ,Set med sensor II och luftvägsadapter Klass IIb 008-0132-00 Luftvägsadapter för vuxen/barn (endast avsett för en användare) Klass I 008-0263-00 Luftvägsadapter med litet skadligt rum (endast avsett för en användare) Klass I 008-0261-00 Luftvägsadapter för vuxen/barn (för flergångsanvändning) Klass I 008-0367-00 Luftvägsadapter för vuxen/barn (endast avsett för en användare) Klass I 008-0370-00 Vätskeavskiljare, Sidestream (10/förp) Klass I 008-0371-00 Vätskeavskiljare, Sidestream (24/förp) Klass I

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