DXXWT0191-00000Panorama Telepack-608

Operating Instructions innovation is the best medicine Panorama TM Datascope® is a U.S. registered trademark of Datascope Corp. Masimo SET® is a U.S. registered trademark of Masimo Corp. Nellcor® is U.S. registered trademark of Tyco International Ltd. Panorama™ is a U.S. trademark of Datascope Corp. Passport 2® is a U.S. registered trademark of Datascope Corp. Spectrum™ is a U.S. trademark of Datascope Corp. Symbol® is a registered trademark of Symbol Technologies, Inc. Copyright © Datascope Corp., 2003. Printed in U.S.A. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Datascope Corp. Panorama™ Operating Instructions0070-00-0575-50i Table of Contents Foreword ....................................................................................................................................................... xiii Warnings, Precautions and Notes..................................................................................................................... xiii Indications for Use .......................................................................................................................................... xix Unpacking Information .................................................................................................................................... xx Symbols and Descriptions ................................................................................................................................ xxi Technical Support ........................................................................................................................................... xxii System Overview ............................................................................................................. 1 - 1 Components of the Panorama System ................................................................................................................ 1 - 2 Licensing Key .......................................................................................................................................... 1 - 3 Supported Devices .......................................................................................................................................... 1 - 4 Panorama Central Station......................................................................................................................... 1 - 6 Panorama Telemetry Server ...................................................................................................................... 1 - 6 Panorama Telepack-2.4 and Panorama Telepack-608.................................................................................. 1 - 7 Panorama Wireless Transceiver (Panorama Telepack-608 only) .................................................................... 1-8 Passport 2® Bedside Monitor.................................................................................................................... 1 - 9 Network Printer ....................................................................................................................................... 1 - 10 Getting Started .................................................................................................................2-1 The Panorama Central Station .......................................................................................................................... 2 - 2 The Main Screen ............................................................................................................................................ 2 - 4 Patient Tiles............................................................................................................................................. 2 - 4 Menu Bar ............................................................................................................................................... 2 - 7 Tabs ...................................................................................................................................................... 2 - 9 Sidebar Buttons ....................................................................................................................................... 2 - 10 Common Controls and Elements ....................................................................................................................... 2 - 11 Quick Reference Guide ................................................................................................................................... 2 - 15 Auto-Admitting a Patient ........................................................................................................................... 2 - 15 Standby ................................................................................................................................................. 2 - 15 Discharge ............................................................................................................................................... 2 - 16 Display................................................................................................................................................... 2 - 17 Patient Alarms ......................................................................................................................................... 2 - 18 Viewing List Trends .................................................................................................................................. 2 - 19 Viewing Events........................................................................................................................................ 2 - 19 Viewing Disclosure .................................................................................................................................. 2 - 20 Troubleshooting .....................................................................................................................................…

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February 2, 2004 Telecommunication Certification Body Radio Frequency Investigation Ltd. Ewhurst Park, Ramsdell Basingstoke Hampshire, RG26 5RQ England Subject: Certification Application for Panorama Telepack – 608 FCC ID: DXXWT0191-00000 Dear Sir or Madam: It is requested that the following information is to be held confidential on behalf of Datascope Corp. for the submission of FCC ID: DXXWT0191-00000, FCC Rules Part 0.459 refers. Exhibit A: Block Diagrams – memo_telepack_040128.doc (1 page) Exhibit B: Schematics – 0742rev8_sch.pdf (5 pages) and 1158rev6_sch.pdf (8 pages) Exhibit C: Parts List –0742pl_8.pdf (5 pages) and 1158pl_6.pdf (3 pages) The above material contains trade secrets and the release of this information could result in substantial competitive harm. Datascope Corp. does not want the exhibits mentioned here to be accessible to the general public. The submitting party on the behalf of Datascope Corp. will prevent any unauthorized disclosure and any previous disclosure to the submitting party will not be available to the general public. Yours sincerely, James Fidacaro Project Manager, Senior Principle Engineer Datascope Corp. Patient Monitoring Division 800 MacArthur Blvd. Mahwah, NJ 07430

LTR DESCRIPTION BY DATE APPROVED 1 Release per CR 27337 MG 08/25/03 GJ 09/05/2003 A Release per CR 27758 BB 11/11/03 GJ 11/14/2003 DATASCOPE 14 Philips Parkway, Montvale, NJ 07645 FILENAME 2661_A Label, Information, Telepack 608 Div. Revision P/M 0334-00-2661-XX A DATASCOPE CORP. (UNPUBLISHED) ALL RIGHTS RESERVED This material is the proprietary information of Datascope Corp. And any use, reproduction, or distribution of the material contained herein, unless specifically authorized by Datascope Corp., is expressly forbidden and would violate the rights and interests of Datascope Corp. Datascope Engineering Form E109.9 Datascope PROPRIETARY Sheet 1 of 4 Specification Control Drawing ____________________________________________________________________________________________ Datascope ® PROPRIETARY 0334-00-2661-XX Sheet 2 of 4 Revision A 1.0 DESCRIPTION The following specification describes an information label for Telepack 608. 2.0 MECHANICAL SPECIFICATIONS 2.1 MATERIAL: Clear 10 mil stock, Lexan, velvet first surface finish, with screen silver for opacity on the back side, permanent self-adhesive backing with release paper. 2.2 TEMPERATURE RATING: -25 o C to +60 o C. 2.3 COLORS: 2.3.1 Background : Datascope #10 (light grey) 2.3.2 Graphics : Munsell 5PB/4-1 (opaque dark grey) 2.4 CONSTRUCTION NOTES: 2.4.1 Graphics to be sub-surface, permanent and scuff proof. 2.4.2 Artwork prepared electronically from EPS files must have a resolution of 2400 DPI, or better, or a line screen of 120 to 150 LPI, if applicable. 2.4.3 The materials used as well as the manufacturer of this label must be listed per UL Recognized Component category: "Marking and Labeling System (PGDQ2)" (based on EN60601-1, section 6.1, determination of durability, and EN 50950, section 1.7.15, Durability). 2.5 PACKAGING: Device to be shipped in manufacturer's standard packaging, stamped or labeled with the following information: 2.5.1 Manufacturer's name or logo. 2.5.2 Datascope Part Number and Revision. 2.5.3 Expiration date. Shelf life to be one (1) year minimum upon receipt by Datascope. Specification Control Drawing ____________________________________________________________________________________________ Datascope ® PROPRIETARY 0334-00-2661-XX Sheet 3 of 4 Revision A 2.0 MECHANICAL SPECIFICATIONS (CONTINUED) 2.6 DIMENSIONS: NOTE: All dimensions are in inches, tolerances are ± .010, unless otherwise specified. Figure 1: Overall dimensions, not to scale 1.514 2.940 2.962 R .140 2 Places R .060 2 Places R13.00 +/- 0.25 background: #10 Light Gray Clear Window No Adhesive All text and graphics: Datascope Text Gray Specification Control Drawing ____________________________________________________________________________________________ Datascope ® PROPRIETARY 0334-00-2661-XX Sheet 4 of 4 Revision A 2.0 MECHANICAL SPECIFICATIONS (CONTINUED) 2.7 ARTWORK: NOTE: Original artwork shall be located at J:\VAULT_PM\0334-00\2661\ Figure 2: Artwork, for reference only ® Datascope Corp., Mahwah, NJ 07430 THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES. SEE INSTRUCTION MANUAL. FCC ID: DXXWT0191-00000 P/N S/N ID IPX 7 0334-00-2661-01 608 Telepack label, information 11.13.2003

Memorandum Detailed description of modulation system There are two modulation schemes, 2-FSK and 4-FSK. The details are as follows: Parameter Requirement Notes Transmit power <10.8 dBm EIRP FCC limit Frequency accuracy ±2.5ppm = ±1.5kHz Modulation – low rate 2FSK in 31.25kHz channel Symbol rate 8.333kSym/s Modulation filtering Gaussian with BT = 0.5 Deviation error ≤ ±15% of nominal Adjacent channel power, channel n ± 1,2 ≤ -60dBc Adjacent channel power, channel n ≥ ± 3 ≤ -83dBc 4 exceptions allowed Frequency lock time ≤ 3s At power-up Transmitter residual FM ≤ 50Hz rms Transmitter microphony ≤ 1kHz peak Under normal handling Out of band spurious emissions f<960MHz ≤ -49.2dBm EIRP ≤ 200μV/m at 3m in 120kHz Out of band spurious emissions 960MHz<f<6.14GHz ≤ -41.3dBm EIRP ≤ 500μV/m at 3m in 1MHz DC voltages and currents into final radio amplifying device Final radio amplifying device is supplied from a DC bias control circuit. The DC voltage is kept below 2.8Volts (typically 2.3V) and the DC current is kept below 18mA (typically 15mA). DC voltage supply to the bias circuit is from a 3.3V + 5% regulated supply line. Means for determining and stabilising frequency, suppression of spurious radiation, limiting modulation and limiting power Means for determining and stabilising frequency: Transmit modulation is generated using a discrete Voltage Control Oscillator (VCO) and Phase Lock Loop (PLL) based frequency synthesiser. A 10MHz VC-TCXO (Voltage Control – Temperature Compensated Crystal Oscillator) is used as reference to the PLL. Suppression of spurious radiation: As stated below, various radio design techniques are applied to ensure spurious radiation is kept well below the specification limits. 1. All transmit stages including the final amplifying stage is designed inside the screening cans. 2. Use of L-C-R (Inductor, Resistor, Capacitor) filters and de-coupling capacitors at various stages of the design. 3. Where possible, band-pass circuit topology/matching was used in the cascaded radio design. 4. A low-pass filter is designed in after the final radio amplifying stage to provide additional suppression of spurious radiation above the transmit frequency. 5. Combination of PIN diode attenuator with DC bias controlling of the final radio amplifying stage is used to attenuated VCO signals below specification limits during power-up and locking the frequency synthesiser circuits of the radio. Limiting modulation: DAC (Digital-to-Analogue) output is Gaussing filtered to keep the modulation within the limits. Limiting power: DC bias control techniques are used on all stages of the transmit radio design to ensure transmit power is kept below the specification limits. Additionally, the radio was design to transmit at least 3dB below 10.8dBm EIRP (specification allowed maximum) under the worst case conditions. Document1

Panorama Telepack – 608 Opera tional Description The Panorama Telepack - 608 is a battery powered ambulatory de vice that acquires ECG information from a patient and transmits it to the Panorama Telemetry Se rver for analysis. The Panorama Telemetry Server is capable of performing data analysis functions such as Heart Rate det ermination, R-wave detection, and ECG filt ering. The Telepack is controlled with buttons, which are located on the front and si de of the device. The status of the unit is shown by the LED indicator lights. Th e Telepack will not turn off unless the batteri es are removed from the uni t or the batteries need to be replaced. The following are the key features of the Telepack: • Uni-directional data transmission ( between ambulatory patient and Panorama Central Station) using wireless communication technology in the WMTS band • Functions such as Nurse Call, Attendant Present, Lead Select, Remote Print and Lead/Battery/Link tests are easily performed using buttons • • LED lights are used to indicate link status, battery status and ECG lead connection status • 3-wire and 5-wire Lead ECG support

Radio Frequency Investigation Ltd, Ewhurst Park, Ramsdell, Basingstoke, Hampshire, RG26 5RQ, ENGLAND. Tel: +44 (0) 1256 851193 Fax: +44 (0) 1256 851192 Registered in England, No. 211 7901. Registered Office: Ewhurst Park, Ramsdell, Basingstoke, Hampshire RG26 5RQ TEST REPORT FROM RADIO FREQUENCY INVESTIGATION LTD. Test of: Datascope Corp. Panorama Telepack - 608 (Body Measurements Only) To: OET Bulletin 65 Supplement C: (2001-01) Measurements were performed on the DASY4 System Test Report Serial No: RFI/SARB1/RP46050JD01A This Test Report Is Issued Under The Authority Of Richard Jacklin, Operations Director: Checked By: Tested By: Release Version No: PDF001 Issue Date: 31 March 2004 Test Dates: 12 March 2004 It should be noted that the standard, OET Bulletin 65 Supplement C: (2001-01) is not listed on RFI’s current UKAS schedule and is therefore “not UKAS accredited”. This report is issued in Adobe Acrobat portable document format (PDF). It is only a valid copy of the report if it is being viewed in PDF format with the following security options not allowed: Changing the document, Selecting text and graphics, Adding or changing notes and form fields. Furthermore, the date of creation must match the issue date stated above. This report may be copied in full. The results in this report apply only to the sample(s) tested. RADIO FREQUENCY INVESTIGATION LTD. TEST REPORT S.No. RFI/SARB1/RP46050JD01A Page 2 of 40 Issue Date: 31 March 2004 Test Of: Datascope Corp. Panorama Telepack - 608 To: OET Bulletin 65 Supplement C: (2001-01) This page has been left intentionally blank. RADIO FREQUENCY INVESTIGATION LTD. TEST REPORT S.No. RFI/SARB1/RP46050JD01A Page 3 of 40 Issue Date: 31 March 2004 Test Of: Datascope Corp. Panorama Telepack - 608 To: OET Bulletin 65 Supplement C: (2001-01) Table of Contents 1. Client Information ............................................................................................................. 4 2. Equipment Under Test (EUT) ........................................................................................... 5 3. Test Specification, Methods And Procedures................................................................ 7 4. Deviations From The Test Specification......................................................................... 8 5. Operation Of The EUT During Testing ............................................................................ 9 6. Summary Of Test Results .............................................................................................. 10 7. SAR Measurement System ............................................................................................ 13 8. SAR Safety Limits ...........................................................................................................14 9. Details of SAR Evaluation .............................................................................................. 15 10. Evaluation Procedures ................................................................................................. 16 11. System Validation ......................................................................................................... 17 12. Simulated Tissues ........................................................................................................ 18 13. Tissue Parameters ........................................................................................................ 19 14. DASY4 Systems Specifications................................................................................... 20 15. Validation results – 900 MHz – 12 March 2004 ........................................................... 21 16. Measurement Uncertainty ............................................................................................ 22 Appendix 1. Test Equipment Used .................................................................................... 25 Appendix 2. SAR Distribution Scans ................................................................................ 26 Appendix 3. Test Configuration Photograph ................................................................... 27 Appendix 4. Calibration Data ............................................................................................. 29 Appendix 5. Photographs of EUT ...................................................................................... 31 RADIO FREQUENCY INVESTIGATION LTD. TEST REPORT S.No. RFI/SARB1/RP46050JD01A Page 4 of 40 Issue Date: 31 March 2004 Test Of: Datascope Corp. Panorama Telepack - 608 To: OET Bulletin 65 Supplement C: (2001-01) 1. Client Information 1.1. Client Details Company Name: Datascope Corp. Address: 800 MacArthur Blvd. Mahwah NJ 07430 0619 United Stated of America Contact Name: Mr J Fidacaro 1.2. Test Laboratory Company Name: Radio Frequency Investigation Ltd. Address: Ewhurst Park Ramsdell Basingstoke Hampshire RG26 5RQ. Contact Name: Mr J Lomako RADIO FREQUENCY INVESTIGATION LTD. TEST REPORT S.No. RFI/SARB1/RP46050JD01A Page 5 of 40 Issue Date: 31 March 2004 Test Of: Datascope Corp. Panorama Telepack - 608 To: OET Bulletin 65 Supplement C: (2001-01) 2. Equipment Under Test (EUT) The following information (with the exception of the Date of Receipt) has been supplied by the client: 2.1. Description of EUT The client has stated that the EUT is a patient worn wireless ECG monitor that forms part of a wireless patient monitor system. 2.2. Identification Of Equipment Under Test (EUT) Brand Name Datascope Corp. Panorama Telepack - 608. Model Name or Number 0998-00-0191-01 Unique type Identification: ME0003AX Serial Number WTP0016 Battery Serial Number 15A LR6 Country Of Manufacture USA Date Of Receipt 12 March 2004 2.3. Modifications Incorporated In EUT During the course of testing the EUT was not modified. RADIO FREQUENCY INVESTIGATION LTD. TEST REPORT S.No. RFI/SARB1/RP46050JD01A Page 6 of 40 Issue Date: 31 March 2004 Test Of: Datascope Corp. Panorama Telepack - 608 To: OET Bulletin 65 …

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Dear Sir Just to confirm that the SAR testing on the EUT was carried out at the nearest calibrated dipole and probe frequency as discussed with Martin Perrine. The scans were done with the EUT transmitting and with the EUT off. Regards Nick Cobb

Radio Frequency Investigation Ltd, Ewhurst Park, Ramsdell, Basingstoke, Hampshire, RG26 5RQ, ENGLAND. Tel: +44 (0) 1256 851193 Fax: +44 (0) 1256 851192 Registered in England, No. 211 7901. Registered Office: Ewhurst Park, Ramsdell, Basingstoke, Hampshire RG26 5RQ TEST REPORT FROM RADIO FREQUENCY INVESTIGATION LTD. Test of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 Test Report Serial No: RFI/MPTB1/RP44457JD02A This Test Report Is Issued Under The Authority Of Richard Jacklin, Operations Director: Checked By: Tested By: Release Version No: PDF01 Issue Date: 01 December 2003 Test Dates: 31 October 2003 to 07 November 2003 This report is issued in Adobe Acrobat portable document format (PDF). It is only a valid copy of the report if it is being viewed in PDF format with the following security options not allowed: Changing the document, Selecting text and graphics, Adding or changing notes and form fields. Furthermore, the date of creation must match the issue date stated above. This report may be copied in full. The results in this report apply only to the sample(s) tested. RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 2 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 This page has been left intentionally blank. RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 3 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 Table of Contents 1. Client Information .........................................................................................................4 2. Equipment Under Test (EUT) .......................................................................................5 3. Test Specification, Methods And Procedures............................................................7 4. Deviations From The Test Specification.....................................................................8 5. Operation Of The EUT During Testing ........................................................................8 6. Summary Of Test Results ............................................................................................9 7. Measurements, Examinations And Derived Results ...............................................10 8. Test Results.................................................................................................................11 9. Measurement Methods ...............................................................................................22 10. Measurement Uncertainty ........................................................................................26 Appendix 1. Test Equipment Used ................................................................................27 Appendix 2. Test Configuration Drawings....................................................................29 RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 4 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 1. Client Information Company Name: Datascope Corp. Address: Patient Monitoring Division 800 MacArthur Blvd. Mahwah NJ 07430-0619 USA Contact Name: Mr J Fidacaro RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 5 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 2. Equipment Under Test (EUT) The following information (with the exception of the Date of Receipt) has been supplied by the client: 2.1. Identification Of Equipment Under Test (EUT) Brand Name: Panorama Telepack – 608 Model Name or Number: 0998-00-0191-01 Serial Number: WTP0016-13 FCC ID DXXWT0191-00000 Country of Manufacture: USA Date of Receipt: 13 October 2003 2.2. Description Of EUT The equipment under test is a patient worn wireless ECG monitor that forms part of a wireless patient monitor system. 2.3. Modifications Incorporated In EUT None. RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 6 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 2.4. Additional Information Related To Testing Power Supply Requirement: 3.0 V DC Nominal (2 x 1.5 V AA Lithium batteries*) Declared Battery End Point Voltage 2.4 V DC Intended Operating Environment: Hospitals Equipment Category: Portable Type of Unit: Transmitter Interface Ports: ECG Connector (x5) RS232 Serial port (service port only for programming of channel by technician) Transmitter Frequency Range 608 MHz to 614 MHz Channel ID Channel Number Channel Frequency (MHz) Bottom 1 608.03125 Transmitter Channels Tested Top 191 613.96875 Occupied Bandwidth: 9.0 kHz Highest Fundamental Frequency: 613.96875 MHz Maximum Fundamental Field Strength 90.2 dBμV/m @ 3 metres * Note: Fully charged lithium AA batteries measure 1.8 V each, therefore 3.6 V is the maximum supply voltage. 2.5. Support Equipment The following support equipment was used to exercise the EUT during testing: Description: Patient Simulator Brand Name: Netech Model Name or Number: MiniSim Serial Number: 18811 Connected to Port: ECG Port of EUT (via EUT’s ECG leads x 5) RADIO FREQUENCY INVESTIGATION LTD TEST REPORT S.No. RFI/MPTB1/RP44457JD02A Operations Department Page 7 of 30 Issue Date: 01 December 2003 Test Of: Datascope Corp. Panorama Telepack - 608 To: FCC Part 95 Subpart H: 2002 3. Test Specification, Methods And Procedures Reference: FCC Part 95 Subpart E: 2002 (Technical Regulations) Title: Code of Federal Regulations, Part 95 (47CFR95) Personal Radio Services. Comments: A description of the test facility used for this test is on file with, and has been accepted by, the Federal Communications Commission as requir…

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