Declaration of Conformity

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Declaration of Conformity: IPRECIO-UCDX10R

EU RE Declaration of Conformity (DoC)

We, PRIMETECH CORPORATION

Koishikawa Daikoku Bldg. 2F, 1-3-25, Koishikawa

Bunkyo-ku, Tokyo 112-0002, JAPAN

declare under our sole responsibility that the product:

Product name……….………………           : Micro Infusion Pump

Trade name………………………….          : iPRECIO®

Type or model……….……………… : UCD-X10R

Relevant supplementary information..: Controlled by PC with dedicated software through LAN

to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the RE Directive (2014/53/EC).

The product is in conformity with the following standards and/or other normative documents:

SAFETY (art 3.1.a): EN 62368-1: 2014+A11:2017+A1:2010+A2:2013+AC:2011+A12:2011

EN 62479: 2010

EMC (art 3.1.b): EN 301 489-1 V2.1.1(2016-11), EN 301 489-3 V2.1.1(2017-03)

SPECTRUM (art 3. 2): EN 300 220-1 V3.1.1(2017-02), EN 300 220-2 V3.1.1(2017-02)

OTHER :…………………….………………………………………………………

(incl. art 3.3 and voluntary specs)^{(title and/or number and date of issue of the standard(s) or other normative document(s))}

Supplementary information:



         Technical file held by : PRIMETECH CORPORATION

                                                        Koishikawa Daikoku Bldg. 2F, 1-3-25, Koishikawa

Bunkyo-ku, Tokyo 112-0002, JAPAN

        Place and date of issue (of this DoC): JAPAN, 15^th/October/2019

Signed by or for the manufacturer:


^{(Signature of authorised person)}

        Name (in writing): Kenichi Seki

        Title: Group Leader, Development Division
Declaration of Conformity: IPRECIO-SMP310R

EU RE Declaration of Conformity (DoC)

We, PRIMETECH CORPORATION

Koishikawa Daikoku Bldg. 2F, 1-3-25, Koishikawa

Bunkyo-ku, Tokyo 112-0002, JAPAN

declare under our sole responsibility that the product:

Product name……….………………           : Micro Infusion Pump

Trade name………………………….          : iPRECIO®

Type or model……….……………     : SMP-310R

Relevant supplementary information..: Package for sterilization

to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the RE Directive (2014/53/EC).

The product is in conformity with the following standards and/or other normative documents:

SAFETY (art 3.1.a): EN 62368-1: 2014+A11:2017+A1:2010+A2:2013+AC:2011+A12:2011

EN 62479: 2010

EMC (art 3.1.b): EN 301 489-1 V2.1.1(2016-11), EN 301 489-3 V2.1.1(2017-03)

SPECTRUM (art 3. 2): EN 300 220-1 V3.1.1(2017-02), EN 300 220-2 V3.1.1(2017-02)

OTHER : ………………………………………………………………………..

(incl. art 3.3 and voluntary specs)^{(title and/or number and date of issue of the standard(s) or other normative document(s))}

Supplementary information:



Technical file held by : PRIMETECH CORPORATION

                                              Koishikawa Daikoku Bldg. 2F, 1-3-25, Koishikawa

Place and date of issue (of this DoC): JAPAN, 15^th/October/2019

Signed by or for the manufacturer:


^{(Signature of authorised person)}

        Name (in writing): Kenichi Seki

        Title: Group Leader, Development Division

Declaration of Conformity: Receivers; 455 kHz, 8 MHz, and 18 MHz

Declaration of Conformity: MX2, CLC, Signal Interface, APR-2

EU DECLARATION OF CONFORMITY

Manufacturer: Data Sciences International Inc.

Address: 119 14^th Street NW, Suite 100, St. Paul, MN 55112 USA

Equipment: Model Name:

Part Number	Model Name
271-0119-xxx	MX2 (Matrix 2.0)
272-8000-xxx	CLC – Physio™ Digital
271-0190-xxx	Signal Interface
275-0025-xxx	APR-2

We, Data Sciences Intl Inc, declare under our sole responsibility that the above referenced products

comply with the following:

Directives: EMC: 2014/30/EU

Assessment procedure:

The conformity assessment procedure detailed in Annex II has been applied.

The following standards have been applied:

MX2 / CLC / Signal Interface APR-2

EN 61326-1: 2013 Industrial Level EN 61326-1:2013

EN 55011: 2009/A1: 2010 Grp 1 Class A EN 55011:2009 +A1:2010

VCCI-CISPR 32: 2016 Class A EN 55032: 2012/AC:2013

EN 60950-1:2006/A11:2009+A1:2010+A12:2011 EN 60950-1:2006/A11:2009+A1:2010+A12:2011+A2:2013

IEC 60950-1:2005 +A1:2009 IEC 60950-1:2005 (ed. 2.); Am 1:2009 +Am2:2013

EN 61000-3-3:2013

EN 61000-3-11:2000

Signed for and on behalf of: Data Sciences International (DSI)

Place: St. Paul, Minnesota, USA Date: 05 February, 2020

Name: Function: Signature:

Mark Hodge Vice President, Operations

Declaration of Conformity: PhysioDetect

Declaration of Conformity: E2S-1

Declaration of Conformity: JET

We, Data Sciences International (DSI), located at 119 14St NW, St. Paul, Minnesota, USA, declare under our sole responsibility that the products:

Part Number	Model Name/Number
270-0240-001	JET 3ETA-EXP
270-0241-001	JET-EA (Diff, LA)
270-0241-002	JET-EA (Diff, Primate)
270-0242-001	JET-3ETA (ECG, LA)
270-0242-002	JET-3ETA (ECG, Primate)
270-0242-003	JET-3ETA (Diff, LA)
270-0242-004	JET-3ETA (Diff, Primate)
270-0243-001	JET-6ETA (ECG/Diff, LA)
270-0243-002	JET-6ETA (ECG/Diff, Primate)
270-0243-003	JET-6ETA (2-ECG, LA)
270-0243-004	JET-6ETA (2-ECG, Primate)
270-0243-005	JET-6ETA (2-Diff, LA)
270-0243-006	JET-6ETA (2-Diff, Primate)
270-0244-001	JET Upgrade (ECG, LA)
270-0244-002	JET Upgrade (Diff, LA)
270-0244-003	JET Upgrade (ECG, Primate)
270-0244-004	JET Upgrade (Diff, Primate)
270-0245-001	JET BP Antenna (Primate)
270-0245-002	JET BP Antenna (LA)
272-0240-001	JET System Receiver
276-0150-L	JET RIP Kit (Primate, large)
276-0150-M	JET RIP Kit (Primate, medium)
276-0150-S	JET RIP Kit (Primate, small)
276-0150-XL	JET RIP Kit (Primate, x-large)
276-0150-XS	JET RIP Kit (Primate, x-small)
276-0150-XXL	JET RIP Kit (Primate, xx-large)
276-0150-XXS	JET RIP Kit (Primate, xx-small)
276-0151-L	JET RIP Kit (LA, large)
276-0151-M	JET RIP Kit (LA, medium)
276-0151-S	JET RIP Kit (LA, small)
276-0151-XL	JET RIP Kit (LA, x-large)
276-0151-XS	JET RIP Kit (LA, x-small)
276-0151-XXL	JET RIP Kit (LA, xx-large)
276-0151-XXS	JET RIP Kit (LA, XX-small)
276-0241-001	JET-EA-BP (Diff, LA)
276-0241-002	JET-EA-BP (Diff, Primate)
276-0242-001	JET-3ETA-BP (ECG, LA)
276-0242-002	JET-3ETA-BP (ECG, Primate)
276-0242-003	JET-3ETA-BP (Diff, LA)
276-0242-004	JET-3ETA-BP (Diff, Primate)
276-0243-001	JET-5ETA-BP (ECG/Diff, LA)
276-0243-002	JET-5ETA-BP (ECG/Diff, Primate
276-0243-003	JET-5ETA-BP (2-ECG, LA)
276-0243-004	JET-5ETA-BP (2-ECG, Primate)
276-0243-005	JET-5ETA-BP (2-Diff, LA)
276-0243-006	JET-5ETA-BP (2-Diff, Primate)
276-0245-001	JET BP Module
276-0247-001	JET BP Add-On (Primate)
276-0247-002	JET BP Add-On (LA)
276-0943-001	JET Battery Charger (Multi-Bay)

are in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).

This is a Blue Tooth device

Supplemental information:
Technical file held by:	Data Sciences International, Inc Place and date of issue: 119 14th Street NW St. Paul, MN 55112 U.S.A.
Marketing	Marketing DSI Europe; France

Signed for or by the manufacturer: For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity: Bias Flow Generator

We, Data Sciences International (DSI), located at 119 14th Street NW, Suite 100, St. Paul, MN 55112 U.S.A. declare under our sole responsibility that the Data Sciences International products:

Model Number	Model Name
600-1200-01	Small Animal Bias Flow Generator 1L/M, 115VAC
600-1200-11	Small Animal Bias Flow Generator 1L/M, 230VAC
600-1200-02	Small Animal Bias Flow Generator 2.5L/M, 115VAC
600-1200-12	Small Animal Bias Flow Generator 2.5L/M, 230VAC
600-1202-01	Large Animal Bias Flow Generator 0-10L/M, 115VAC
600-1202-11	Large Animal Bias Flow Generator 0-10L/M, 230VAC

to which this declaration relates, meet the essential requirements and are in conformity with the relevant EU requirements below:

EU EMC Directive 2004/108/EC

The products are compliant with the following standards and/or other normative documents:

CSA/UL61010-1:04 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General Requirements (including Canadian and United States National Deviations).

EN 55011:2007
EN 61000-4-2:1995 including A1:1998 and A2:2001
EN 61000-4-3:2002
EN 61000-4-4:2004
EN 61000-4-5:1995 including A1:2001
EN 61000-4-6:2003
EN 61000-4-11:2004
EN 61000-3-2:2006
EN 61000-3-3:1995, including A1:2001 and A2:2005

Supplementary information:
Technical file held by:	Data Sciences International, Inc. Place and date of issue: 119 14th Street NW, St. Paul, Minnesota, 55112 USA
	Marketing DSI Europe; France

Signed for or by the manufacturer: For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity: PNM-P3P-7002XS

Declaration of Conformity: PNM-P3P-7002XE

Declaration of Conformity: PNM-P3P-7002

Declaration of Conformity: Signal Conditioners

We, Data Sciences International (DSI), located at 119 14th Street NW, St. Paul, MN 55112 U.S.A. declare under our sole responsibility that the Data Sciences International products:

Model Number	Model Name	Tests Series
13-7715-02	ABDC 32	(6) (13)
13-7715-04	ABDC 4	(6)
13-7715-05	Digital I/O	(13)
13-7715-30D	Bridge / Transducer Module	(13)
13-7715-35	Carrier Module	(6) (13)
13-7715-58	Universal module	(13)
13-7715-59	Universal XE Module	(2) (6)
13-7715-68	D/A Module	(6) (13)
13-7715-70	DCOM Module	(2) (6)
13-7770-BIO12	BIO POD	(6)
13-7770-ECG12	ECG POD	(2)

to which this declaration relates, meet the essential requirements and are in conformity with the relevant EU requirements below:

EU EMC Directive 2004/108/EC

The products are compliant with the following standards and/or other normative documents:

EN60601-1-2: 2nd Edition Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

Emissions & Immunity:

Test Series (2)

EN 55011:2007	EN 61000-4-2:1995	EN 61000-4-3:1996	EN 61000-4-4:1995
EN 61000-4-5:1995	EN 61000-4-6:1996	EN 61000-4-8:1993	EN 61000-4-11:1994
EN 61000-3-2:2006	EN 61000-3-3:1995, including A1:2001 and A2:2005

Test Series (6)

EN 55011:2006	EN 61000-4-2:1995	EN 61000-4-3:1996	EN 61000-4-4:1995
EN 61000-4-5:1995	EN 61000-4-6:1996	EN 61000-4-8:1993	EN 61000-4-11:1994
EN 61000-3-2:2006	EN 61000-3-3:1995, including A1:2001 and A2:2006

Test Series (13)

IEC 61000-4-2	IEC 61000-4-3	IEC 61000-4-4	IEC 61000-4-5	IEC 61000-4-6	IEC 61000-4-8
IEC 61000-4-11	CISPR 11:2003-03, 4TH Edition			CISPR 11:2006 4.1 Edition
EN 61000-3-2:2000, A2:2005		EN 61000-3-3:1995, A1:2001

Supplementary information:
Technical file held by:	Data Sciences International, Inc. Place and date of issue: 119 14th Street NW, St. Paul, Minnesota, 55112 USA
	Marketing DSI Europe; France

Signed for or by the manufacturer: For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity: PhysioTel Digital

We, Data Sciences International (DSI), located at 119 14th Street NW, Suite 100, St. Paul, MN 55112 U.S.A., declare under our sole responsibility that the products:

Part Number	Model Name	Model Numbers
270-0311-xx-xx-xx-F2	PhysioTelDigital Smart Implant	L11
270-0321-xx-xx-xx-F2	PhysioTel Digital Smart Implant	L21
270-0300-xx-xx-xx-F2	PhysioTel Digital Smart Implant	L00
270-0400-xx-xx-xx-F2	PhysioTel Digital Smart Implant	M00
270-0401-xx-xx-xx-F2	PhysioTel Digital Smart Implant	M01
270-0410-xx-xx-xx-F2	PhysioTel Digital Smart Implant	M10
270-0410-xx-xx-xx-F2	PhysioTel Digital Smart Implant	M11
272-9001-xxx	PhysioTel Digital Transceiver
275-0024-xxx	PhysioTel Digital Power On Detector

is in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).

The product is compliant with the following harmonized standards and/or other normative documents:
SPECTRUM	EN 300 -220-2 / V2.4.1
EMC SAFETY	EN 301-489-1 V1.9.1 EN 301-489-3 V1.4.1 EN 61010-1:2001
Supplementary information:
Technical file held by:	Data Sciences International Inc. Place and date of issue: 119 14th Street NW St. Paul, MN 55112 U.S.A.
	Marketing DSI Europe; France

Signed for or by the manufacturer: For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity - Discontinued Products

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Declaration of Conformity: 455 kHz Transmitters

We, Data Sciences International (DSI), located at 119 14th Street NW, St. Paul, Minnesota, 55112 USA, declare under our sole responsibility that the products:

Part Number	Model Name
270-0023-xxx	TA10TA-F20
270-0040-xxx	TA11PA-C40
270-0064-xxx	TL11M2-C50-PT
270-0092-xxx	TL11M2-C50-PXT
270-0161-xxx	TA11PAC10-TOX

are in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).

The products are compliant with the following standards and/or other normative documents:
SAFETY	EN 61010-1:2001
EMISSIONS	EN 302-536-2:2007
EMC	EN 301-489-1 EN 301-489-3
Supplementary information:
Technical file held by:	Data Sciences International, Inc. Place and date of issue: 119 14th Street NW, St. Paul, Minnesota, 55112 USA
	Marketing DSI Europe; France

Signed for or by the manufacturer:
For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity (DofC): VivaQuant

Declaration of Conformity: Repeaters

We, Data Sciences International (DSI), located at 119 14th Street NW, St. Paul, Minnesota, 55112 USA, declare under our sole responsibility that the products:

Part Number	Model Name	Model Numbers
272-0401-4xx	Repeater, RPT-4xx-1, Large Animal	RPT-4xx-1
272-0402-4xx	Repeater, RPT-4xx-2, Large Animal	RPT-4xx-2
272-0403-4xx	Repeater, RPT-4xx-3, Large Animal	RPT-4xx-3
272-1401-4xx	Repeater, RPT-4xx-1, Primate	RPT-4xx-1
272-1402-4xx	Repeater, RPT-4xx-2, Primate	RPT-4xx-2
272-1403-4xx	Repeater, RPT-4xx-3, Primate	RPT-4xx-3

is in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC).

The product is compliant with the following harmonized standards and/or other normative documents:
SAFETY	EN 61000-2.3.4.5.6
SPECTRUM (art 3.2)	EN 300-330-2
EMC (art 3.1.b)	EN 301-489-3
Supplementary information:
Technical file held by:	Data Sciences International, Inc. Place and date of issue: 119 14th Street NW, Suite 100, St. Paul, Minnesota, 55112 USA
Marketing	Marketing DSI Europe; France

Signed for or by the manufacturer:
For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Declaration of Conformity: A.R.T. Data Acquisition Hardware

We, Data Sciences International (DSI), located at 119 14th Street NW, St. Paul, MN 55112 U.S.A. declare under our sole responsibility that the Data Sciences International products:

Model Number	Model Name
	A.R.T. Data Acquisition System Hardware
271-0117-001	Data Exchange Matrix 20 Channel
271-0129-001	Data Exchange Matrix 4 Source Analog Out
271-0129-002	Data Exchange Matrix 8 Source Analog Out
275-0020-001	APR-1 Ambient Pressure Reference System
261-0034-001	CQ2240 Card
261-0017-001	CQ2010 Card
272-0400-410	RMC-410
272-0400-420	RMC-420
272-0400-430	RMC-430
272-0400-440	RMC-440

to which this declaration relates, meet the essential requirements and are in conformity with the relevant EU requirements below:

EU EMC Directive 2004/108/EC
The products are compliant with the following standards and/or other normative documents:

EMC:
Emissions – 272-6001-001, 272-6002-001, 275-0020-001, 271-0117-001 and 261-0034-001 - EN 61326-1: 1997
Emissions - 271-0129-001, 271-0129-002, and 261-0017-001 – EN 55022: 1994
Immunity – 272-6001-001, 272-6002-001, and 275-0020-001 – EN 61326: 1997 + Amendment A1: 1998

Table 1 – Minimum Immunity Test Requirements

Immunity - 271-0117-001 and 261-0034-001 – EN 55024: 1998
Immunity - 271-0129-001, 271-0129-002, and 261-0017-001 – EN 50082-1: 1992

Supplementary information:
Technical file held by:	Data Sciences International, Inc. Place and date of issue: 119 14th Street NW, St. Paul, Minnesota, 55112 USA
	Marketing DSI Europe; France

Signed for or by the manufacturer: For a signed version of the DoC, call a DSI representative or by email to: productinfo@datasci.com.

Product Warranty

Returning Products to DSI

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Part Number	Model Name
270-0011-xxx	CTA-D70
270-0021-xxx	CA-F40
270-0033-xxx	TA-D70
270-0034-xxx	TA-F40
270-0036-xxx	EA-F20
270-0037-xxx	TA-F40 W/TP
270-0041-xxx	CTA-F40
270-0042-xxx	ETA-F20
270-0044-xxx	PA-D70
270-0066-xxx	F50-EET
270-0087-xxx	F50-EEE
270-0091-xxx	D70-EEE
270-0093-xxx	D70-PCT
270-0124-xxx	F20- EET
270-0126-xxx	D70-PCTP
270-0134-xxx	F40-EET
270-0135-xxx	PA-C10
270-0136-xxx	D70-CCTP
270-0138-xxx	TA-F50
270-0147-xxx	F40-TT
270-0160-xxx	ETA-F10
270-0162-xxx	TA-F10
270-0163-xxx	D70-PCTR
270-0164-xxx	PA-C10-TOX-LA
270-0165-xxx	PA-C10-TOX-SA
270-0166-xxx	PA-C10
270-0170-xxx	HD-X11
270-0171-xxx	HD-X10
270-0172-xxx	HD-X02
270-0173-xxx	HD-S02
270-0180-xxx	HD-S10
270-0192-xxx	HD-S21
270-0193-xxx	HD-S11-F0
270-0194-xxx	HD-XG
270-0197-xxx	HD-S1-F0
270-0199-xxx	HD-S20
270-0600-xxx	CA-EXT

Part Number	Model Name
270-0142-002	4ET-S2
270-0196-xxx	HD-S11-F2
270-0153-xxx	F50-W-F2

Part Number	Model Name
272-6001-001	RPC-1
272-6002-001	RMC-1
272-6006-001	RPC-2
272-6008-001	RPC-3
272-6012-001	RSC-1

Declaration of Conformity

Declaration of Conformity: 455 kHz Transmitters

Declaration of Conformity: 18 MHz Transmitters

Declaration of Conformity: 8 MHz Transmitters

Declaration of Conformity: IPRECIO-UCDX10R

Declaration of Conformity: IPRECIO-SMP310R

Declaration of Conformity: Receivers; 455 kHz, 8 MHz, and 18 MHz

Declaration of Conformity: MX2, CLC, Signal Interface, APR-2

Declaration of Conformity: PhysioDetect

Declaration of Conformity: E2S-1

Declaration of Conformity: JET

Declaration of Conformity: Bias Flow Generator

Declaration of Conformity: PNM-P3P-7002XS

Declaration of Conformity: PNM-P3P-7002XE

Declaration of Conformity: PNM-P3P-7002

Declaration of Conformity: Signal Conditioners

Declaration of Conformity: PhysioTel Digital

Declaration of Conformity - Discontinued Products

Declaration of Conformity: 455 kHz Transmitters

Declaration of Conformity (DofC): VivaQuant

Declaration of Conformity: Repeaters

Declaration of Conformity: A.R.T. Data Acquisition Hardware

About DSI

Products

Resources

Part Number	Model Name
275-0027-002	PhysioDetect Receiver, F2

Model Number	Model Name
PNM-P3P-7002XS	ACQ7700 USB Two Slot Case

Model Number	Model Name
PNM-P3P-7002XE	ACQ7700 USB 13 Slot Case

Model Number	Model Name
PNM-P3P-7002	ACQ7700 USB Six Slot Case

Declaration of Conformity

Declaration of Conformity - Discontinued Products

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