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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
Declaration of ConformityNumber : DOCE012
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 791100
Name: Power Supply
to which this declaration relates is in conformity with the following standards
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
Declaration of ConformityNumber : DOCE013
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 96100, 96102, 96104, 96150, 96152, and 96154
Name: PneumoCheck Spirometer
to which this declaration relates is in conformity with the following standards
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: May 11, 1999
Rev. 12/95
Declaration of ConformityNumber : DOCE026
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the Product
Model Number: LCI-100CE
Name: Video imaging 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 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 19, 1995
Rev. 1/96
Declaration of ConformityNumber : DOCE027
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: LCI-200CE, CIS-200CE, 83-1339
Name: Video Imaging System
to which this declaration relates is in conformity with the following standards
EN 60601-1-2, 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 theapproximation of laws of Member States relating to electromagnetic compatibility.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: January 4, 1996
Declaration of ConformityNumber : DOCE030
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
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 44100, 44102, 44104, 44112, 44114
Name: LS100 Exam Light
to which this declaration relates is in conformity with the following standards
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
Declaration of ConformityNumber : DOCE031
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 44200, 44202, 44204
Name: LS 200 Exam Light
to which this declaration relates is in conformity with the following standards
EN 55015 Limits and methods of measurement of radio disturbance characteristics ofelectrical 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 andthe provisions of European Council Directive 73/23/EEC Relating to electricalequipment designed for use within certain voltage limits.
Quality Assurance Manager Signed:Welch Allyn, Inc. Date: May 7, 1999
Declaration of ConformityNumber : DOCM032
Manufacturer: Welch Allyn, Inc.
Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
Model Number: 49032, 49034, 49036, 49020, 49022, 49024, 49026, 49500, 49500TW, and 49540
Name: Headlights
to which this declaration relates is in conformity with the following standards
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
Declaration of ConformityNumber : DOCM036
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 67775 Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 46022, 46023, 46050, 46070, 46072, 46074, and 46076
Name: Direct Focusing and Solid State Portable Headlight
to which this declaration relates is in conformity with the following standards
EN 60601-1, EN 60601-1-2, EN 980, 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: September 29, 2003
Declaration of ConformityNumber : DOCE041
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: HLS24-2, HLS24-4, HLS24-6.
Name: Industrial Light Source
to which this declaration relates is in conformity with the following standards
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.
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: September 4, 1997
Declaration of ConformityNumber : DOCE043
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
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79060Fax.+353 46 27181
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards
EN 50081-2: Electromagnetic compatibility - Generic emission standard part 2. Industrial environment.
EN 50082-2 Electromagnetic compatibility - Generic immunity 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 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
Declaration of ConformityNumber : DOCE044
Manufacturer: Welch Allyn inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Rd,
Skaneateles falls, NY. 13153-0220
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: XLAMS-LSA, XLAMS-LSA-P
Name: Measurement system for Video Probe XL.
to which this declaration relates is in conformity with the following standards
EN 50081-2: Electromagnetic compatibility - Generic emission standard part 2. Industrial environment.
EN 50082-2 Electromagnetic compatibility - Generic immunity 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 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
Declaration of ConformityNumber : DOCE045
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.
Representative: European Regulatory Manager,Welch Allyn Ltd.Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 70705Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards
EN 50081-1 Electromagnetic compatibility - Generic emission standard part 2. Industrialenvironment.
EN 50082-2 Electromagnetic compatibility - Generic immunity 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.
Quality Assurance Manager Signed:Welch Allyn, Inc. Date: May 2, 1997
Declaration of ConformityNumber : DOCE047
Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Manufacturing site: Diatek InstrumentsAddress: 7420 Carroll Road,
San Diego, CA 92121-2334.U.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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 20812-XXX
Name: Model 9600 Calibration Tester.
to which this declaration relates is in conformity with the following standards
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.
Following the provisions of European Council Directive 89/336/EEC. On theapproximation of laws of Member States relating to electromagnetic compatibility.
Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: September 4, 1996
Declaration of ConformityNumber : DOCE049
Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Representative: European Regulatory Manager,Welch Allyn Ltd.
Adress: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityNumber : DOCE058
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.
Representative: European Regulatory Manager,Welch Allyn Ltd.Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 28122Fax. +353 46 28536
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: CIS-200CES, CIS-200S.
Name: Video Processor
to which this declaration relates is in conformity with the following standards
EN 50081-1 Electromagnetic compatibility - Generic emission standard part 2. Industrialenvironment.
EN 50082-2 Electromagnetic compatibility - Generic immunity 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.
Quality Assurance Manager Signed:Welch Allyn, Inc. Date: May 2, 1997
Declaration of ConformityNumber : DOC063
Sub Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityNumber : DOCE080
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220
Manufacturing site: Welch Allyn Inc.Address: 4619 Jordan Road,
Skaneateles Falls, NY. 13153-0220
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
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: November 6, 1998
Declaration of ConformityDOCE093
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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
Declaration of ConformityDOCE096
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79060Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the product,
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
Declaration of ConformityDOCE097
Manufacturer: Everest VITAddress: 4619 Jordan Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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
Declaration of ConformityDOCE099
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79060Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityNumber : DOCM001
Manufacturer: Welch Allyn, Inc.
Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: September 3, 1998
Declaration of ConformityNumber : DOCM005
Manufacturer: Welch Allyn, Inc.
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
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 79282, 79284, 79286
Name: Pocket Scope charger
to which this declaration relates is in conformity with the following standards
EN 60601-1, EN 60601-1-2, 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 Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 23, 1998
Declaration of ConformityDOCM014
Manufacturer: Welch Allyn, Inc.
Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityDOCM014a
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the following product,
Model Number: 23220, 23221, 23222, 23223, 72320, and 72329
Name: AM 232 Manual Audiometer 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 withthe 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 ofAnnex IX of this Directive.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityNumber : DOCM016
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
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityDOCM016a
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
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Kells 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: 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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityNumber : DOCM021
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd,
Arden NC 28704-9739 USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd,
Arden NC 28704-9739 USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 31, 1996
Declaration of ConformityNumber : DOCM022
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 67775 Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityNumber : DOCM028
Manufacturer: Welch Allyn, Inc.
Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards
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
Declaration of ConformityNumber : DOCM029
Manufacturer: Welch Allyn, Inc.
Address: 4341 State Street Road,Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 48622, 48624, 48632, and 48634
Name: Exam Light II
to which this declaration relates is in conformity with the following standards:
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 8, 2000
Declaration of ConformityNumber : DOCM038
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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.
Regulatory Manager Signed: Welch Allyn Inc. Date 8/11/2003
Declaration of ConformityNumber : DOCM042
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: Navan Business Park 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 product,
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
to which this declaration relates is in conformity with the following standards:
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
Declaration of ConformityNumber : DOCM046
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 7, 1999
Declaration of ConformityNumber : DOCM047
Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Adress: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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.
to which this declaration relates is in conformity with the following standards
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 7, 1999
Page 1 of 2
Declaration of ConformityNumber : DOCM048
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells Road, Navan, County Meath, Republic of Ireland.
Tel. +353 46 90 67700 Fax.+353 46 90 67754
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityNumber : DOCM049
Manufacturer: Welch Allyn Inc.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
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
Declaration of ConformityDOCM050a
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 22, 2000
Declaration of ConformityDOCM050
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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
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 IIa under Rule(s) #5 & #10 of AnnexIX of this Directive.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityDOCM052
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the following product,
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
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, 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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityDOCM053
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the following product,
Model Number: 23303, 23305, 23307, 23400, 71025, 71032, 71034, 71036,71039, 71040, 71123, 72300, 72322, 72324, 72325, and72326
Name: AudioScope 3 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 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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityNumber : DOCM056
Manufacturer: Welch Allyn, Inc.Address: 4619 Jordan Road
Skaneateles Falls, NY 13153-0220USA
Manufacturing site: Welch Allyn, Inc.4619 Jordan RoadSkaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 48901, 48911, 48010, and 48020
Name: VDX-300 Imaging and Illumination Platform. DistalVu II Laparoscope.
to which this declaration relates is in conformity with the following standards
EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 60601-2-18, andEN 1441
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 9, 2000
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
to which this declaration relates is in conformity with the following standards
EN 60601-1, EN 60601-1-2, EN 1441, EN 980, 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.
Regulatory Manager Signed : Welch Allyn, Inc. Date: February 4, 1998
Declaration of Conformity Number : DOCM059
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
Representative: European Regulatory Manager, Welch Allyn Ltd.
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
Declaration of ConformityNumber : DOCM061
Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
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 1 under Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: June 22, 1998
Declaration of ConformityNumber : DOCM062
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, and ISO 10993-1
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 27, 1998
Declaration of ConformityNumber : DOCM064
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 67775 Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 25, 2002
Declaration of ConformityNumber : DOCM065
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, EN 980, EN 1041, EN 1441, and ISO 7376-1
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 25, 2002
Declaration of ConformityNumber : DOCM066
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 26030
Name: Bi-valve Illuminator
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, EN 980, EN 1041: 1994, and EN 1441
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: December 15, 1997
Declaration of ConformityNumber : DOCM067
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 1, 2001
Declaration of ConformityNumber : DOCM068
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 12452, 12454
Name: Strabismoscope
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: January 26, 1998
Declaration of ConformityNumber : DOCM069
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
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: 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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 12 of Annex IX of this Directive.
Sr. Regulatory Affairs Manager Signed: Welch Allyn Inc. Date: September 25, 2003
Declaration of ConformityNumber : DOCM071
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
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: 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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 12 of Annex IX of this Directive.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: November 9, 2001
Declaration of ConformityNumber : DOCM072
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 92132, 92134, 93312, 93314
Name: Compact Sets
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: January 26, 1998
Declaration of ConformityNumber : DOCM073
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 92802, 92804, 92812, 92814, 94812, 94814, and 92821
Name: Pocketscope
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 Rule 12 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 9, 1998
Page 1 of 2
Declaration of ConformityNumber : DOCM074
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 12 of Annex IX of this Directive.
Page 2 of 2
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 10, 2001
Declaration of ConformityNumber : DOCM075
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Manufacturing site: Diatek InstrumentsAddress: 7420 Carroll Road,
San Diego, CA 92121USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 9000, 9020
Name: InstaTemp 9000, Clinical Thermometer
to which this declaration relates is in conformity with the following standards
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
Declaration of ConformityNumber : DOCM076
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 67775 Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, 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 12 of Annex IX of this Directive.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 10, 2001
Declaration of ConformityNumber : DOCM077
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards:
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
Declaration of ConformityNumber : DOCM078
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
Representative: European regulatory Manager, Welch Allyn Ltd.
Address: Navan Business Park 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 product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, EN 60601-1-2, EN 980, EN 1041, and ISO 14971
Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rule 5 of Annex IX of this Directive.
Sr. Mgr. Regulatory Affairs Signed: Welch Allyn Inc. Date January 6, 2004
Declaration of ConformityDOCM081
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Manufacturing Site Welch Allyn, Inc.Address: Kells Road, Navan,
County Meath,Republic of Ireland.
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 243032, 243033, 243034, 243035
Name: Ear Speculum, EarSpec
to which this declaration relates is in conformity with the following standards:
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
Declaration of ConformityDOCM082
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Manufacturing Site Welch Allyn, Inc.Address: Kells Road, Navan,
County Meath,Republic of Ireland.
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 19090, 19091, 19092, 19093, 19190, 19191, 19192,19193, 29090, 29092, 99090, 99091, 99092, and 99093
Name: Klinic Ophthalmoscope and Otoscope
to which this declaration relates is in conformity with the following standards:
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
Declaration of ConformityDOCM083
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the product,
Model Number: 47300, 47310, 47320, 47351, 47352, 47352-C, 47354,and 47370
Name: Episcope
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, 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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: May 25, 1999
Declaration of ConformityNumber : DOCM084
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
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
to which this declaration relates is in conformity with the following standards:
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: February 8, 2000
Declaration of ConformityDOCM085
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 28000 and 28100
Name: Tongue Blade Holder
to which this declaration relates is in conformity with the following standards:
EN 60601-1, 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 1 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 7, 1998
Declaration of ConformityDOCM086
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1, 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 1 of Annex IX of thisDirective.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: July 7, 1998
Declaration of ConformityNumber : DOCM087
Manufacturer: Welch Allyn Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220U.S.A.
Manufacturing site: Speidel + Keller GmbH & Co. KGAddress: Zollerstrasse 2-4
D-72417 JungingenGermany
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax. +353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 45-15-389, 45-15-489, 45-15-589, 50-31-189, 50-81-189, and 50-84-189
Name: Mechanical Sphygmomanometer
to which this declaration relates is in conformity with 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 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
Declaration of ConformityDOCM088
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 31500, 31530, 31550, 31750, and 45500
Name: VideoPath Endoscopes
to which this declaration relates is in conformity with the following standards:
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 25, 1999
Declaration of ConformityNumber : DOCM089
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Manufacturing site: Welch Allyn, Inc.Address: 4619 Jordan Road
Skaneateles NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: DXU-1000
Name: C.O.D.X.
to which this declaration relates is in conformity with the following standards:
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: May 7, 1999
Declaration of ConformityDOCM090
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the product,
Model Number: 621SO, 621SP, 622SO, 622SP, 622NO, 622NP, 623SP, and623NP
Name: Atlas Monitor
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, 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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 3, 1999
Declaration of ConformityDOCM091
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
Model Number: 29200, 29210, and 29220
Name: AudioPath
to which this declaration relates is in conformity with the following standards:
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: August 5, 1999
Declaration of ConformityNumber : DOCM092
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Manufacturing site: Welch Allyn, Inc.Address: 95 Old Shoals Rd
Arden, NC 28704USA
Representative: European regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc. declares under its sole responsibility that the product,
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.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: September 13, 1999
Declaration of ConformityDOCM094
Manufacturer: Welch Allyn, Inc.Address: 4341 State Street Road,
Skaneateles Falls, NY 13153-0220USA
Representative: European Regulatory Manager,Welch Allyn Ltd.
Address: Kells Road, Navan,County Meath,Republic of Ireland.Tel. +353 46 79075Fax.+353 46 27128
Welch Allyn, Inc., declares under its sole responsibility that the product,
Model Number: 14000, 14001, 14002, 14004, 14006, 14010, 14012, 14014,and 14016
Name: SureSight Vision Screener
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 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
Declaration of Conformity Number : DOCM095
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 67775 Fax. +353 46 27128
We Welch Allyn declare under our sole responsibility that the Product
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.
Regulatory Manager Signed: Welch Allyn Inc. Date 10/13/2003
Declaration of ConformityDOCM098
Manufacturer: Welch Allyn, Inc. Address: 4341 State Street Road, Skaneateles Falls, NY 13153-0220 USA
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: 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
to which this declaration relates is in conformity with the following standards:
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
Declaration of ConformityDOCM100
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
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards:
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.
Regulatory Manager Signed: Welch Allyn Inc. Date 04/7/2003
Declaration of ConformityDOCM101
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
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
Model Number: 4200-60, 4200-62, 4200-64, 4200-70, 4200-84, 4200-170, 4200-200, 4200-250
Name: Spot Check Device Accessories
to which this declaration relates is in conformity with the following standards:
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.
Regulatory Manager Signed: Welch Allyn Inc. Date 04/4/2003
Declaration of ConformityDOCM102
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
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Navan Business Park, 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 product,
Model Number: 29300, 29350
Name: Ear Wash System
to which this declaration relates is in conformity with the following standards:
EN 30993-1, EN 46001, ISO 9001
Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rule(s) #5 and #12 of Annex IX of this Directive.
Quality Assurance Manager Signed: Welch Allyn, Inc. Date: October 7, 2002
Declaration of ConformityDOCM104
Manufacturer: Welch Allyn, Inc. Address: 4619 Jordan Road, Skaneateles Falls, NY 13153-0220 USA
Manufacturing Site Welch Allyn, Inc. Address: Skaneateles Falls, NY USA
Representative: European Regulatory Manager, Welch Allyn Ltd.
Address: Kells 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 product,
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
to which this declaration relates is in conformity with the following standards:
EN 60601-1 and EN 60601-1-2
Following the provisions of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Device is Class 1 under Rule(s) #5 and #12 of Annex IX of this Directive.
Corporate Regulatory Affairs Manager Signed: Welch Allyn, Inc. Date: January 2, 2003
Declaration of ConformityDOCM105
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
Declaration of ConformityDOCM106
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: 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.
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
Declaration of ConformityDOCM107
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: 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.
Declaration of Conformity valid since: 17.03.1999
Quality Management Signed: Herbert BiermannSpeidel + Keller / Welch Allyn Date: 17.03.1999
Declaration of ConformityDOCM108
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: 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.
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
Declaration of ConformityDOCM109
Manufacturer: Welch Allyn Inc.95 Old Shoals RoadArden , NC 28704USA
Manufacturing site: Speidel+Keller GmbH & CoKGWelch AllynZollerstr. 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: 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.
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
Declaration of ConformityDOCM110
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: 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.
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: 14.02.2000
Quality Management Signed: Herbert BiermannSpeidel + Keller / Welch Allyn Date: 14.02.2000
Declaration of ConformityDOCM111
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: 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.
Declaration of Conformity valid since: 14.02.2000
Quality Management Signed: Herbert BiermannSpeidel + Keller / Welch Allyn Date: 14.02.2000
Declaration of ConformityDOCM112
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: 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.
Declaration of Conformity valid since: 14.02.2000
Quality Management Signed: Herbert BiermannSpeidel + Keller Welch Allyn Date: 14.02.2000
Declaration of ConformityNumber : DOCM113
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 67775 Fax.+353 46 27128
We Welch Allyn declare under our sole responsibility that the Product
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.
Regulatory Manager Signed: Welch Allyn Inc. Date 04/4/2003
Declaration of ConformityNumber : DOCM113a
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 67775 Fax.+353 46 27128
We Welch Allyn declare under our sole responsibility that the Product
Model Number: 6100-10, 6100-11, 6100-12, 6100-13, 6100-14
Name: ABPM 6100, Ambulatory Blood Pressure Monitor Accesories
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, 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.
Regulatory Manager Signed: Welch Allyn Inc. Date 04/4/2003
Declaration of ConformityNumber : DOCM114
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: Navan Business Park Dublin Road,Navan,County Meath,
Republic of Ireland. Tel. +353 46 67775 Fax.+353 46 27128
We Welch Allyn declare under our sole responsibility that the Product
Model Number: 715 Series
Name: Humphrey Matrix
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 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.
Declaration of Conformity valid since: 01.01.2004
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 3 of 16
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
Beaverton, OR-USASeptember 2001 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 4 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 5 of 16
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 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 6 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 7 of 16
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 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 8 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 9 of 16
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
Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany
Beaverton, OR-USASettembre 2001 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 10 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 11 of 16
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
Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany
Beaverton, OR-USASeptember 2001 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 12 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 13 of 16
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
Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany
Beaverton, OR-USASetembro 2001 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 14 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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
830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series Page 15 of 16
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
Medical Product Service GmBHBorngasse 20 35619 Braunfels, Germany
Beaverton, OR-USASeptember 2001 ______________________________________
Don M. Abbey, VP of Quality Systems
Page 16 of 16 830-0486-03 Rev B Declaration of Conformity, Propaq 1XX Series
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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