PCPNX-300Nexi-Clip

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2 v Instructions for Use NEXAN
SYSTEM Nx-300 300-USM-103 US Issue 1.0 €—2P22SI Index w——2 2— 2   2  These instructions are intended for the Health Care Professional, as a guide to the use of the Nx-300 System including the Nexan Software -Nexoft (found in the Telemonitoring Station computer). It is assumed that the user of the Telemonitoring Station and Nexoft is a Registered Medical Practitioner who has experience of using Windows Software on a PC. The Patient is the user of the Nexi, Nexi-Clip, PDA, Base Station and Auxiliary Sensors. A set of instructions, called ‘Patient Guide’ is intended to be left with the patient (to assist him/her with day-to-day-use) A set of instructions called ‘READ ME FIRST’ is provided with each Nexi for patient application of Nexi and Nexi-Clip. … 2— —™ 2  —  To obtain service contact Nexan Customer Support on 770-360-9090. e——˜2 2g ™—2ƒ2h—— Clinical Study data, obtained using the Nx-300, is available on request from Nexan Ltd. Nexan Ltd, cautions the reader of this manual: •This manual, wholly or partially, is subject to change without notice. Some features described in this manual may not be available with this Nexan system. •All rights are reserved: No one is permitted to reproduce or duplicate, in any form, the whole or part of this manual without the permission of Nexan Ltd. •Nexan assumes no responsibility for usage not in accordance with this manual resulting in illegal or improper use of the Nexan system. 300-USM-103 US Issue 1.0 €—2Q22SI Index g   SECTION 1 Important information General warnings & precautions .................................................................................. 5 Glossary of symbols & terms ........................................................................................ 7 Environment ................................................................................................................. 7 Symbols on Nx-300 system labelling ........................................................................... 8 Intended use ............................................................................................................... 10 Contra-indications: ................................................................................................ 10 SECTION 2 Overview of Nx-300 system System description ..................................................................................................... 11 Description of parts: ................................................................................................... 12 Parts supplied ............................................................................................................. 13 System setup and operation ....................................................................................... 14 SECTION 3 Setting up the PDA and Base Station Configuring the PDA ................................................................................................... 15 Accessing the HCP menu ..................................................................................... 15 Clearing the memory ............................................................................................ 16 Configuring the PDA for a new Nexi-clip ............................................................... 17 Other Configure PDA options ............................................................................... 17 Viewing signals and data to check Nexi operation ............................................... 18 Setting the PDA Clock and Calendar .................................................................... 20 Viewing stored schedule information .................................................................... 20 Configuring the Base Station ...................................................................................... 21 Accessing the HCP Menus ................................................................................... 21 Setting the PDA (PDL) ID code ............................................................................. 23 Setting the Patient ID code ................................................................................... 24 Setting or editing the measurements schedule ..................................................... 25 300-USM-103 US Issue 1.0 €—2R22SI SECTION 4 Setting up and using the TeleMonitoring Station TeleMonitoring Station (TMS) overview ...................................................................... 26 Setting up the TMS computer ..................................................................................... 27 Connecting the TMS ............................................................................................. 27 Switching on the TMS ........................................................................................... 27 Using Nexoft ............................................................................................................... 28 Logging on ............................................................................................................ 28 Patient Records .................................................................................................... 30 Using the Calendar function to set a download schedule ..................................... 33 Initiating an immediate download ......................................................................... 36 Viewing Downloaded Data .................................................................................... 37 Printing Information ............................................................................................... 39 On-line help ................................................................…

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MECHANICAL DESIGN DRAWING Drawing no.: 00531-MDD-02 CR: 000980  Nexan Ltd 2000 Tel: +44 (0) 1223 713500 Fax: +44 (0) 1223 713501 Title: US Nexi-Clip device label Builds: LAB-00531-02 ORIGINATOR Chris Lewis CHECKED Peter Lewis APPROVED J Pisani DATE: 23 Nov 00 DATE: 23 Nov 00 DATE: 23 Nov 00 C:\My Documents\TCB\Trans applications (in process)\PCPNX-300\Revised documentation\additional docs.zip\00531-MDD-02 US Nexiclip device label.doc Page 1 of 1  Nexan Ltd 2000 NEXAN® Ltd. CB5 8RE.UK Nexi® - Clip NCL-00519-01 Patents Pending FCC ID: PCPNX-300 Radius- 1.0 mm Radius- 5.0 mm Text in Arial font Text colour : black Regular Text height greater than or equal to 1.8mm ‘Patents Pending’ and ‘FCC ID: PCPNX-300’ text in small type, but must be visible to the naked eye. 34.5m m 12.0 mm NOTES: 1. Label material colour- Light grey (closest to Pantone 428) 2. Label Material –polyester type (not metalised) 3. Label Adhesive- Scotch 300LSE Hi Strength or similar 4. Rub Tests- as for Thermal transfer printing Locate label on back of Nexi®-Clip at bottom of rectangular recess AECG Type 1

See test report exhibit for photos

Gen III SDS 300-DES-001 Issue 1.1 C:\My Documents\TCB\Trans applications (in process)\PCPNX- 300\Curtis 8.zip\300-DES-001Gen III SDS Issue 1.1.doc Page 1 of 30 Document Reference No: 300-DES-001 Title: System Design Specification for Generation III Nexystem Issue: Issue 1.1 Dated: 3-July-2000 Supersedes: 1.0 Date Name Signature Author/Origin: 3-Jul-00 M Llewellyn Reviewed By: 5-Jul-00 J Pisani Approved By: 5-Jul-00 G Lay This document is the property of Nexan Telemed Limited. The information contained herein is strictly confidential, is not for public disclosure and is not to be duplicated or distributed in any manner without the express written consent of the owner. NEXI, NEXAN, NEXYSTEM, NEXISENSOR, NEXENDER, NEXTATION, NEXOFT are Trademarks of Nexan Telemed Ltd. Gen III SDS 300-DES-001 Issue 1.1 C:\My Documents\TCB\Trans applications (in process)\PCPNX- 300\Curtis 8.zip\300-DES-001Gen III SDS Issue 1.1.doc Page 2 of 30 CHANGE HISTORY Issue Date Author Amendments Draft A 27-1-00 P. Howard First Draft Draft B 2-2-00 P. Howard Updates following first informal review Draft C 16-2-00 P. Howard Updates following 2 nd informal review Draft D 1-3-00 P. Howard Updates following SDIT meeting of 29-2-00 Draft E 10-3-00 P. Howard Updates following review of 9-3-00 Issue 1 14-3-00 P. Howard Updated for Issue Issue 1.1 03-July-2000 M.Llewellyn Respiration analysis detail INCOMPLETENESS RECORD 1. Protocol and transmission rate of PDL to BSU interface is undefined. 2. PDL battery recharge time is undefined. 3. Compression methods for PDL to BSU and BSU to TMS data transfers are undefined. Gen III SDS 300-DES-001 Issue 1.1 C:\My Documents\TCB\Trans applications (in process)\PCPNX- 300\Curtis 8.zip\300-DES-001Gen III SDS Issue 1.1.doc Page 3 of 30 TABLE OF CONTENTS 1 Introduction.............................................................................................................................................5 1.1. Purpose...........................................................................................................................................5 1.2. Scope..............................................................................................................................................5 1.3. Amendment.....................................................................................................................................5 1.4. Related Documents..........................................................................................................................5 1.5. Abbreviations...................................................................................................................................5 2 System Architecture................................................................................................................................6 3 Functional Distribution.............................................................................................................................7 3.1. Nexisensor and Oxygen Saturation Sensor......................................................................................7 3.1.1. Physiological Measurements......................................................................................................7 3.1.2. Transfer of Measurement...........................................................................................................8 3.1.3. Provision of Power for E-patch...................................................................................................8 3.1.4. Non-functional requirements......................................................................................................8 3.2. E-patch............................................................................................................................................8 3.2.1. Sampling the Data.....................................................................................................................9 3.2.2. Encoding of Measurements.......................................................................................................9 3.2.3. Local storage of Encoded Data..................................................................................................9 3.2.4. Conversion of Data For Transmission......................................................................................10 3.2.5. Transmission of Data...............................................................................................................10 3.2.6. Transmission of Predetermined Bit Sequence..........................................................................10 3.2.7. Self-test...................................................................................................................................10 3.2.8. Non-functional requirements....................................................................................................10 3.3. Portable Data Logger.....................................................................................................................10 3.3.1. Data Capture and Transfer......................................................................................................11 3.3.1.1. Reception of Transmissions..............................................................................................11 3.3.1.2. Manual and Automatic Configuration of E-patch Identity....................................................11 3.3.1.3. Recovery of Data...............................................................................................................12 3.3.1.4. Compression of Data.........................................................................................................12 3.3.1.5. Storage of Data.................................................................................................................12 3.3.1.6. Transmission of Data to BSU.....................................................................................…

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BOM number: 00527-BOM-02 © Nexan Telemed Ltd Title: Gen 3 US E-Patch PCB AssemblyDate:4-Oct-00 Tel +44 (0) 1223 713500 Builds part:ASS-00527-01Change requestDCR-0352 Fax +44 (0) 1223 713501 ItemQtyReferenceDescriptionNexan Part No.Manufacturer. Man. Part No.SupplierNotes 11 ANT1 869/916MHz EPatch loop antennaMEC-00374-01Nexan00374-MAD-01 22 C1,C2 Capacitor 33p 50V 0603 COGCAP-0010RohmMCH185A330J 315 C3,C4,C5,C6,C7,C8,C25,C 26,C28,C29,C52,C56,C61, C69,C70 Capacitor 100n 16V 0603 X7RCAP-0034RohmMCH183C104K 42 C9,C30 Capacitor SM Tant 10u 6V3 Case A CAP-0089 AVXTAJA106K006X 52 C10,C54 Capacitor 2n2 50V 0603 X7RCAP-0031AVXMCH185C222K 66 C11,C12,C15,C23,C64,C66 Capacitor 82p 50V 0603 COGCAP-0086RohmMCH185A820J 71 C13,C16 Capacitor 1p8 50V 0603 COGCAP-0118RohmMCH185A1R8C 81 C14 Ceramic trimmer SM 2mm 2.5-6 pFCAP-0087MuRataTZV02 series 91 C17 Capacitor 2p2 50V 0603 COGCAP-0066RohmMCH185A2R2C 101 C18 Capacitor 220p 50V 0603 COGCAP-0007RohmMCH185A221J 111 C19 Ceramic trimmer SM 2mm 3-10pFCAP-0088MuRataTZV02 series 122 C20,C65 Capacitor 22p 50V 0603 COGCAP-0006RohmMCH185A220J 131 C21 Capacitor 15n 50V 0603 X7RCAP-0082RohmMCH182C153K 143 C22,C53,C58 Capacitor 100p 50V 0603 COGCAP-0002RohmMCH185A101J 152 C24,C27 Capacitor SM Tant 100u 6V3 Case C CAP-0092 AVXTPSC107K006R0150 183 C31,C40,C48 Capacitor SM Tant 4u7 10V Case A CAP-0093 AVXTAJA475K010X 195 C32,C38,C42,C46,C72 Capacitor SM Tant 1u 25V Case ACAP-0069AVX TAJA105K025X 207 C33,C37,C39,C45,C47,C62 ,C63 Capacitor 4p7 50V 0603 COGCAP-0017RohmMCH185A4R7C 216 C34,C36,C41,C44,C49,C51 Capacitor 1n 50V 0603 X7RCAP-0029RohmMCH185C102K 223 C35,C43,C50 Capacitor 4n7 50V 0603 X7RCAP-0085RohmMCH185C472K 251 C55 Capacitor SM Tant 0.47u 25V Case A CAP-0091 AVXTAJA474K25R 262 C60,C57 Capacitor 22n 25V 0603 X7RCAP-0084RohmMCH182C223K 272 C59,C71 Capacitor 220n 16V 0805 X7RCAP-0108RohmMCH213C224K 281 C65 Capacitor 22p 50V 0603 COGCAP-0006RohmMCH185A220J 292 C68,C67 Capacitor 10n 50V 0603 X7RCAP-0030RohmMCH185C103K 301 D1 SMD Schottky diodeSEM-0076ZetexZHCS500 311 D2 Signal diode SM dual common cathodeSEM-0055FairchildBAW56 322 D4,D3 Schottky diode SM dual series connectionSEM-0077STBAT54SFILM 331 J1 ELCO SM wiping contact connector 4wayCON-0108ELCO58.9155.004.000.010 341 J2 ELCO SM wiping contact connector 3wayCON-0107ELCO58.9155.003.000.015 351 J3 Edge finger 2W 0.1" (no component fitted) 361 J5 Jack socket 2.5mm 3 pole SMCON-0080SMKSMK2009-0201 371 LD1 Not Fitted 3813 L1,L2,L5,L6,L9,L10,L11,L12 ,L13,L14,L15,L16,L17 Chip Ferrite 1000R @ 100MHzIND-0020MuRataBLM21A102S 392 L3,L4 Inductor 0603 150nH wirewoundIND-0021Coilcraft0603CS-R15XJBC 402 L8,L7 Inductor SM 1210 47uH 300mAIND-0038MurataLQH3C470K34 411 Q1 FET P-Channel Enhancement modeSEM-0028SiliconixTP0101T 425 R1,R3,R4,R51,R57 Resistor SM 33K 1% 0603RES-0011 RohmMCR03EZPF333 431 R2 Resistor SM 330R 1% 0603RES-0085 RohmMCR03EZPF331 4410 R17,R18,R23,R27,R28,R33 ,R36,R37,R41,R48 Resistor SM 1M 1% 0603RES-0083 RohmMCR03EZPF105 Page 1 of 2 BOM number: 00527-BOM-02 © Nexan Telemed Ltd Title: Gen 3 US E-Patch PCB AssemblyDate:4-Oct-00 Tel +44 (0) 1223 713500 Builds part:ASS-00527-01Change requestDCR-0352 Fax +44 (0) 1223 713501 ItemQtyReferenceDescriptionNexan Part No.Manufacturer. Man. Part No.SupplierNotes 454 R6,R8,R58,R46 Resistor SM 47K 1% 0603RES-0035 RohmMCR03EZPF473 461 R7 Resistor SM 1K2 1% 0603RES-0091 RohmMCR03EZPF122 471 R9 Resistor SM 160K 1% 0603RES-0101 RohmMCR03EZPF164 482 R69,R10 Resistor SM 120K 1% 0603RES-0018 RohmMCR03EZPF124 491 R11 Resistor SM 0R0 1% 0603RES-0007 RohmMCR03EZHJ000 501 R12 Resistor SM 15K 1% 0603RES-0016 RohmMCR03EZPF153 515 R13,R20,R30,R39,R68 Resistor SM 100K 1% 0603RES-0008 RohmMCR03EZPF104 536 R16,R22,R25,R31,R34,R42 Resistor SM 10M 5% 0603RES-0063 RohmMCR18EZHJ106 553 R19,R29,R38 Resistor SM 270K 1% 0603 RES-0084RohmMCR03EZPF274 574 R21,R32,R40,R52 Resistor SM 22K 1% 0603RES-0052 RohmMCR03EZPF223 587 R43,R44,R45,R47,R49,R50 ,R63 Resistor SM 220K 1% 0603RES-0023 RohmMCR03EZPF224 611 R54 Resistor SM 3K3 1% 0603RES-0086RohmMCR03EZPF332 622 R55,R56 Resistor SM 180R 1% 0603RES-0082 RohmMCR03EZPF181 6313 R59,R60,R61,R15,R24,R26 ,R35,R64,R65,R66,R67,R7 0,R71 Resistor SM 10K 1% 0603RES-0037Multicomp 651 U1 LDO adjustable regulatorSEM-0118MaximMAX8864SEUK-T 661 U2 RISC microcontroller 128K flash 4K RAM 4MHzSEM-0078AtmelATMega103L-4AC 671 U3 MAX6301CSA Reset ControllerSEM0141MaximMAX6301CSA 681 U4 (MUST BE PROGRAMMED BEFORE FITTING) 8 bit low voltage RISC micro 512B ROMSEM-0084MicrochipPIC16LC620A-04SS Print label showing Firmware Version 691 U5 Single gate schmitt inverterSEM-0079Texas InstrumentsSN74AHC1G14DBVR 701 U7 TH7108 Issue 2 868/815 MHz FSK/ASK/FM TransmitterSEM-0080ThesysTH7108.2 711 U8 Low power switching regulatorSEM-0081MaximMAX859CUA 723 U10,U11,U12 Op Amp TLV2434CPWSEM-0082Texas InstrumentsTLV2434CPW 731 U13 Op Amp LMV324MTSEM-0083 National SemiconductorLMV324MT 741 X1 Crystal SM 4MHzCRY-0014IQDA120F 751 X2 Crystal 916.5MHz TX (28.640625MHz)CRY-0030Hy-Q28.640625MHz 00424-CS 761 PCB PCB-00284-03 772 L18,L19 Inductor 0603 39nH wirewoundIND-0041Coilcraft0603CS-39NXJBC 781 R62 Resistor SM 470R 1% 0603RES-0019 RohmMCR03EZPF471 792 C73,C74 Capacitor 47n 16V 0603 X7RCAP-0038RohmMCH183C473K 801 Firmware for U2 PRO-00527U2V1_5NexanPRO-00527U4V1_5 Programm after fit 811Firmware for U4PRO-00527U4V1_0NexanPRO-00527U4V1_0Record software version on J/C. ORIGINATORCHECKEDAPPROVEDRELATED DOCSDocument number Barry ElbornDuncan EvansJustin PisaniManufacturing process00489-MP-0A Assembly InstructionN/A Test specification00504-TS-0A DATE10/4/00DATE 04/10/00DATE Circuit Diagram00283-CD-0A Page 2 of 2

E-PATCH PCBBOTTOM SIDE DETAILS Nexan Ltd. The Quorum, Barnwell Road, Cambridge. CB5 8RE UK Tel +44(0)1223 713500 Fax +44 ( 0 ) 1223 713501 TITLE: 000284-BS DRAWING No. ISSUE: 03

5 5 4 4 3 3 2 2 1 1 DD CC BB AA E-patch / Nexi Interconnection Pulseoximeter Electrodes 00283-CD1 Generation 3 Epatch - Top Level Nexan Telemed Ltd A3 16Wednesday, September 20, 2000 Title SizeDocument NumberRev Modify Date:Sheet of Approved By Reviewed ByDate Date Block 3 Impedance Circuit Resp#2_IP_Buff Resp#1_IP_Buff Resp_Out Resp_Drive_RA Resp_Drive_V5 50kHz_clock V_REF_ECG Block 1 ECG Front end ECG_OUT_V11 ECG_OUT_V5 ECG_OUT_Flying RA_ELECTRODE V5_ELECTRODE FLYING_ELECTRODE LA_ELECTRODE LL_ELECTRODE Resp#1_IP_Buff Resp#2_IP_Buff V_REF_ECG Block 5 Radio Transmitter DATA_IN ENABLE_IN Block 4 Digital Section RF_DATA RF_EN AUX_RXD CLK_50KHZ ADC0 ADC1 ADC2 ADC3 ADC4 AUX_STATUS AUX_TXD Block 2 Power Supply BATT_STATUS V_REF_ECG V_BAT J3 Power 1 2 L16BLM11A102S J5 SMK2009-0201 1 2 3 4 L17BLM11A102S J1 ELCO 4way 1 2 3 4 J2 ELCO 3way 1 2 3 5 5 4 4 3 3 2 2 1 1 DD CC BB AA Gain and Demodulator Square to sine conversion Constant current feed Final Amp 00283-CD1 Generation 3 EPatch - Respiration Circuit Nexan Telemed Ltd A3 26Wednesday, September 20, 2000 Title SizeDocument NumberRev Modify Date:Sheet of Approved By Reviewed ByDate Date V_REF_ECG V_REF_ECG 2.7V AGND AGND AGND C60 22n + C55 0u47 25V + - U13D LMV324 12 13 14 R44 220K C54 2n2 C26 100n R54 3K3 R50 220K R52 22K_0603 R47 220K R43 220K L14 BLM11A102S L15 BLM11A102S R49 220K R45 220K + - U13A LMV324 3 2 1 R42 10M C58 100p C63 4p7 TP15 R48 1M C62 4p7 TP16 U13E LMV324 4 11 V+ GND C61 100n + - U13B LMV324 5 6 7 C68 10n R46 47K R55 180R C57 22n C53 100p C59 220n 0805 D2 BAW56 R51 33K_0603 C69 100n + - U13C LMV324 10 9 8 R64 10K C67 10n C56 100n R56 180R R57 33K_0603 + - U12C TLV2454 10 9 8 L8 LQH3C470K24 R63 220K Resp#1_IP_Buff Resp#2_IP_Buff Resp_Out 50kHz_clock Resp_Drive_RA Resp_Drive_V5 V_REF_ECG 5 5 4 4 3 3 2 2 1 1 DD CC BB AA (ECG and Resp) (ECG and Resp) (Reference) 00283-CD 1 Generation 3 EPatch - ECG Front End Nexan Telemed Ltd A3 36Wednesday, September 20, 2000 Title SizeDocument NumberRev Modify Date:Sheet of Approved By Reviewed ByDate Date Resp#1 V_REF_ECG Resp#2 Ref_i/p Resp#2 V_REF_ECG Ref_i/p Ref_i/p AGND AGND AGND AGND AGND AGND 2.7V AGND AGND AGND + C72 1u0_25V_CaseA R17 1M R67 10K U12E TLV2454 4 11 V+ GND R37 1M R65 10K C52 100n R66 10K + - U11D TLV2454 12 13 14 C37 4p7 + - U10B TLV2454 5 6 7 + C38 1u0_25V_CaseA C44 1n R39 100K R36 1M U10E TLV2454 4 11 V+ GND + - U11B TLV2454 5 6 7 R21 22K R35 10K C29 100n C70 100n + - U11A TLV2454 3 2 1 C28 100n + C42 1u0_25V_CaseA + - U12D TLV2454 12 13 14 R22 10M C51 1n + - U10C TLV2454 10 9 8 R32 22K + - U12B TLV2454 5 6 7 C39 4p7 + - U10D TLV2454 12 13 14 + C31 4u7 10V + - U12A TLV2454 3 2 1 + C46 1u0_25V_CaseA + C32 1u0_25V_CaseA R24 10K R18 1M R29 270K R16 10M C41 1n U11E TLV2454 4 11 V+ GND L9 BLM11A102S R25 10M L10 BLM11A102S R31 10M L11 BLM11A102S R34 10M L12 BLM11A102S C34 1n L13 BLM11A102S C36 1n R26 10K C47 4p7 + C40 4u7 10V TP10 C35 4n7 TP11 R38 270K C43 4n7 TP12 C49 1n R19 270K TP13 C33 4p7 TP14 R71 10K R331M R231M + - U11C TLV2454 10 9 8 + C48 4u7 10V R28 1M R15 10K C50 4n7 C45 4p7 R30 100K R27 1M R20 100K R411M + - U10A TLV2454 3 2 1 R40 22K ECG_OUT_V11RA_ELECTRODE LA_ELECTRODE LL_ELECTRODE FLYING_ELECTRODE V5_ELECTRODE ECG_OUT_V5 ECG_OUT_Flying Resp#1_IP_Buff Resp#2_IP_Buff V_REF_ECG 5 5 4 4 3 3 2 2 1 1 DD CC BB AA 1. VCC 2. SCK 3. MOSI/RXD 4. MISO/TXD 5. RESET 6. GND ISP Connector: Debug LED Data pump tick 00283-CD1 Generation 3 Epatch - Digital Section Nexan Telemed Ltd. A3 46Wednesday, September 20, 2000 Title SizeDocument NumberRev Modify Date:Sheet of Approved By Reviewed ByDate Date CLK_BUF DP_D5 DP_D7 DP_RELOAD DP_D7 DP_D0 DP_D3 DP_D0 DP_D2 DP_D4 DP_D5 DP_D1 DP_D3 DP_D4 DP_D[0..7] DP_D1 DP_D6 DP_D2 DP_D6 4MHz_CLK DP_LE DP_RELOAD PWR_CTRL DP_LE RESET 2.7V 2.7V 2.7V 2.7V 2.7V 2.7V2.7V 2.7V 2.7V 2.7V 2.7V 2.7V 2.7V V_BATV_BAT 2.7V D4 BAT54S 3 21 C5 100n_16V_0603 R60 10K_0603 TP2 R2 330R_0603 TP4 R1 33K_0603 C8 100n_16V_0603 C25 100n_16V_0603 C7 100n_16V_0603 R8 47K_0603 TP5 LD1 LED 3mm RED R59 10K_0603 TP6 R61 10K_0603 C3 100n_16V_0603 TP7 U2 ATMega103L-4AC 51 50 49 48 47 46 45 44 35 36 37 38 39 40 41 42 34 33 43 10 11 12 13 14 15 16 17 2 3 4 5 6 7 8 9 25 26 27 28 29 30 31 3254 55 56 57 58 59 60 61 1 20 64 2152 2253 24 23 19 18 62 63 PA0(AD0) PA1(AD1) PA2(AD2) PA3(AD3) PA4(AD4) PA5(AD5) PA6(AD6) PA7(AD7) PC0(A8) PC1(A9) PC2(A10) PC3(A11) PC4(A12) PC5(A13) PC6(A14) PC7(A15) RD WR ALE PB0(SS) PB1(SCK) PB2(MOSI) PB3(MISO) PB4(OC0/PWM0) PB5(OC1A/PWM1A) PB6(OC1B/PWM1B) PB7(OC2/PWM2) PE0(PDI/RXD) PE1(PDO/TXD) PE2(AC+) PE3(AC-) PE4(INT4) PE5(INT5) PE6(INT6) PE7(INT7) PD0(INT0) PD1(INT1) PD2(INT2) PD3(INT3) PD4(IC1) PD5 PD6(T1) PD7(T2)PF7(ADC7) PF6(ADC6) PF5(ADC5) PF4(ADC4) PF3(ADC3) PF2(ADC2) PF1(ADC1) PF0(ADC0) PEN RESET AVCC VCCVCC GNDGND XTAL1 XTAL2 TOSC1 TOSC2 AREF AGND C6 100n_16V_0603 TP3 C73 47n_16V_0603 R70 10K_0603 Q1 TP0101T 1 2 3 R62 470R_0603 U4 PIC16LC620A-04SS 7 8 9 10 11 12 13 14 5 16 1 2 3 19 20 4 1817 6 15 RB0/INT RB1 RB2 RB3 RB4 RB5 RB6 RB7 VSS VDD RA2 RA3 RA4/TOCKI RA0 RA1 MCLR OSC1OSC2 VSS VDD 4MHz_5SMX X1 R3 33K_ 0603 C133p_50V_0603 C4 100n_16V_0603 D3 BAT54S 3 21 R4 33K_ 0603 C233p_50V_0603 TP1 U3 MAX6301CSA 1 2 3 45 6 7 8 RST IN GND SRT SWTWDS WDI RESET VCC U5 74AHC1G14DBVR 24 5 3 C74 47n_16V_0603 R58 47K_0603 C66 82p_50V_0603 C64 82p_50V_0603 RF_DATA AUX_RXD CLK_50KHZ ADC0 ADC1 ADC2 ADC3 ADC4 RF_EN AUX_STATUS AUX_TXD 5 5 4 4 3 3 2 2 1 1 DD CC BB AA PSU ground star point 00283-CD1 Generation 3 Epatch - Power Supply Nexan Telemed Ltd A4 56Wednesday, September 20, 2000 Title SizeDocument NumberRev Modify Date:Sheetof Approved By Reviewed ByDate Date SW_OUTSW_OUT V_BAT V_BAT AGND 2.7V AGND R68 100K U1 MAX8864SEUK-T 1 2 34 5 SHDN GND INOUT SET L7 LQH3C470K24 R69 120K R10 120K R11 0R0_0603 + C24 100u 6.3V +C27 100u 6.3V R13 100K_0603 U8 MAX859 1 2 3 45 6 7 8 SHDN F/B REF LBOLBI OUT GND LX R12 15K_0603 C65 22p C71 220n 0805 TP8 R9 160K TP9 +C30 10u 6V3 D1 ZHCS500 BATT_STATUS V_REF_ECG 5 5 4 4 3 3 2 2 1 1 DD CC BB AA Component changes for US (916MHz version)…

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E-PATCH PCB TOP SIDE DETAILS Nexan Ltd. The Quorum, Barnwell Road, Cambridge. CB5 8RE UK Tel +44(0)1223 713500 Fax +44(0)1223 713501 TITLE: 000284-TS DRAWING No.ISSUE: 03

EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 1 of 24 TEST REPORT ON NX 300 E Patch UHF Digital FSK Transmitter 916.100 - 916.900 MHz FCC Procedures Part 15 TEST REPORT NUMBER CTMS 2000/1512c October 2000 Prepared for: Nexan Ltd The Quorum, Barnwell Road, Cambridge, England. This results in this report refer to the tested unit only EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 2 of 24 CAMBRIDGE TEST & MEASUREMENT SERVICES Certificate of Application Cambridge Test and Measurement Services Ltd., certifies that the product tested was fully compliant with the requirements of Parts 15 of the FCC Code of Regulations 47CFR, the results of which are contained in this test report No: CTMS 2000/1512c I certify that the application was prepared under my supervision and that to the best of my knowledge and belief, the facts set forth in this application and technical data, are true and correct. Signature : Date: Name: David Fisher Title: Radio Technical Manager EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 3 of 24 General Test Information Date Test Sample Received:22/09/2000 Date Testing Started:25/09/2000 Date Testing Finished:26/09/2000 Equipment Serial Number:000006 CTMS Project Number :2000/1512c Test Engineer:D.Fisher Report Copy No 1 EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 4 of 24 Contents list and Information 2.1033 Application for Certification For use in accordance with FCC Rules and Regulations 47 CFR parts 2 and parts 15. 2.1033 (b) (1)Name of applicant : Nexan Ltd. Address of applicant:The Quorum, Barnwell Road, Cambrigde,CB5 8RE, England. Contact :Mr. P.Lewis, 2.1033 (b) (2)FCC Identifier:PCP NX-300 Model Type Number:NX 300 E Patch 2.1033 (b) (3)Installation and operating instructions :User Guide, see exhibit 2.1033 (b) (4)Brief description of circuit function:see exhibit 2.1033 (b) (5)Block diagram showing frequency 2.1034 of oscillators:see exhibit 2.1033 (b) (6)Report of measurements 15Subpart A General 15.31Measurement standards (OATS):Page 5 15.33Frequency range of radiated measurements:Page 6 15.35Measurement detector and bandwidths:Page 6 15Subpart C Intentional Radiators 15.249Radiated emission limits:Page 7 2.1033 (7)Photographs of equipment and identification plate / label:Pages 10 General Information and Attachments : Company Accreditations & Credentials:Page 17 EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 5 of 24 15.31Measurement standards The measurement facilities at Cambridge Test and Measurement Services LTD, are in accordance with ANCI C63.4 and lodged with the FCC under rule 2.948, a letter from the FCC recognising compliance with the requirements was dated March 02,1999 with the registration number 93385. Open Area Test Site (OATS) Transmission Axis 3 m EUT d where d is the maximum EUT dimension 2D 3m 40 m 10 m Automatic Turntable LISN LISN ̊ ̊3.D 1 - 4 m Automa st ESVS10 Receiver Fibre Optic Control Feeds PC Controller EUT Equipment Test Set Up Antenna to EUT Distance EUT Mains Supply: Fed under the ground plane EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 6 of 24 Frequency spectrum to be investigated - 47 CFR 15.33 The level of frequency search was from the lowest radio frequency generated to the 10 th Harmonic of the fundamental frequency of the highest carrier frequency. (9.165 GHz) Measurement detector and bandwidths 47 CFR 15.35 Measurements below 1000 MHz are taken using a quasi-peak detector which has been calibrated to the requirements of CISPR 16-1. For frequencies above 1000MHz a minimum resolution bandwidth of 1MHz was employed. General Test Conditions Laboratory environment . Ambient Temperature :21 °C Relative Humidity : 48 % Open Area test Site :18 °C Test Instruments used Receiver:Rohde & Schwarz type ESHS 10 Receiver:Rohde & Schwarz type ESVS 10 Spectrum Analyser:Advantest type R3271 Antenna:Schaffner Chase bi-log type CBL6141A Antenna:Emco active loop type 6502 Antenna:Emco double ridged guide horn type 3115 EQUIPMENT : NX 300 E Patch TransmitterTEST REPORT NUMBER: CTMS 2000/1512c FCC Identifier : PCP NX-300CTMS FCC Registration Number: 93385 Page 7 of 24 Transmitter emission limits- 47 CFR 15.249 The Transmitter (the EUT) fitted with a new battery pack and body patch. Set to 100 % continuous transmit and was placed on a wooden table at a distance of 3m from the receiving antenna the radiated field for each spurious emission …

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