PQCM2601BMedical Telemetry Transmitter

Instructions for Use Philips Telemetry System with the M2601B Transmitter and Telemetry Functions at the IntelliVue Information Center Part Number: M2600-92201 Printed in the U.S.A. November 2004 First Edition Notice Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. ii Notice Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment. Printed in the USA. Document number: M2600-92201 © Copyright 2004 Koninklijke Philips Electronics N.V. All Rights Reserved. OxiCliq and OxiMax are registered trademarks of Nellcor Incorporated. Printing History New editions of this document incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Pages that are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. First Edition................................................................ November 2004 Philips Telemetry System, model M2600B is compatible with: M2604A Philips Mainframe, #01D or #0EU, revision E.00.19 Philips Information Center, revisions F.00, E.01, E.00, D.01, D.00 M2636B TeleMon Companion Monitor, Options A02/A03 Philips Transmitter, model M2601A Philips Transmitter, model M1400A/B/J Note—Some features are not available on all products. About this Book iii About this Book This book contains operating instructions for use of the M2601B Transmitter, a part of the Philips Telemetry System. It also includes operational information for the telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use the equipment in a healthcare environment. For operating information on other functionality of the Information Center, see the IntelliVue Information Center Instructions for Use (order number M3150-9001F). For preventive maintenance, repair, and test methods for verification of device performance, refer to the M2600B Philips Telemetry System Service Guide in the M2600B Documentation Kit, shipped with the product (order number M2600-90323). This book does not address Philips IntelliVue TRx transceivers or the Philips IntelliVue Telemetry System. For information on those products, refer to the manual Philips IntelliVue Telemetry System Instructions for Use (order number M4841-91001). Note—Standard and EASI M2601A Transmitters can be used with the Philips Telemetry System and can operate simultaneously with M2601B Transmitters. “What’s New” on page 1-2 summarizes the differences between the M2601B and M2601A transmitters. About this Book iv Document Conventions Procedures Procedures are indicated in text by the heading Task Summary followed by the following table: Bold Typeface Objects of actions in procedures appear in bold typeface. Note the following example: Click the Standby button. Warnings WarningWarning Warnings are information you should know to avoid injuring patients and personnel. Cautions Caution Cautions are information you should know to avoid damaging your equipment and software. Notes Note—Notes contain additional information on Philips Telemetry System usage. StepAction 1 2 3 Product Safety Information v Product Safety Information The warnings below refer to the following devices: •Philips M2601B Transmitter •Philips Telemetry System •IntelliVue Information Center WarningWarning For continued safe use of this equipment, it is necessary that the listed instructions are followed. Instructions in this manual in no way supersede established medical procedures. WarningWarning Do not touch the patient, or table, or instruments during defibrillation. The battery door must be closed during defibrillation. These steps protect the clinician from high defibrillator voltage. WarningWarning This device is not to be used in the vicinity of electrosurgery units because use may interrupt or interfere with the transmission of signals from the transmitter. WarningWarning This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. Product Safety Information vi WarningWarning Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power. WarningWarning Use of product accessories (e.g., ECG lead sets, SpO 2 sensors) other than those prescribed by Philips could lead to patient injury. WarningWarning Strangulation Hazard! Under no circumstances should any pouch be tied solely around a patient’s neck. WarningWarning ECG SAFETY FOR ALL PATIENTS Always confirm Information Center observations with clinical observation of the patient before administering interventions. Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts. Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion. When switching between EASI and Standard monitoring, there is a loss of data for 30 seconds. Product Safety Information vii WarningWarning ECG SAFETY FOR PACED PATIENTS The output power of the M2601B Transmitter and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the …

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Philips Medical Systems To: Date: From: Subject: Federal Communications Commission, Washington, DC 20554 August 30, 2004 Barry Wyshogrod, Philips Medical Systems, Andover, MA Application for Radio Grant and associated Request for Confidentiality Dear Sir or Madam, Philips Medical Systems of Andover, Massachusetts hereby submits the enclosed application for Equipment Authorization under 47 CFR Part 95, Subpart H for a wireless medical telemetry transmitter, Mode! M2601 B. The M2601 B telemetry transmitter is the evolution of the current M2601 A device, authorized as PQCM2601 A-95 on 20-Aug-2002. The M2601 B has no functional radio changes from the M2601 A; radio signal characteristics, frequencies, and power output all remain identical. The M2601 B circuitry is implemented with new components to address parts obsolescence issues. The industrial design (packaging) was changed from the M2601 A to address commercial needs. Upon receipt of this grant, the grant 10 number will be applied to the device. Furthermore, the instruction to the user concerning frequency coordination (as per 47 CFR 95.1109) will appear on the cover of the associated Instructions for Use and Service Manual. This filina includes: 1. Block Diagram & Functional Description 2. Schematics 3. Bill of Material 4. Internal Device Photographs 5. Part 95 Test Report Under the provisions of Section O.457(d) of the Commission's Rules, and Section 552(b)(4) of the Freedom of Information Act, Philips Medical Systems hereby requests that items 1-5 listed above be granted Indefinite Confidentiality from public disclosure, as this information is deemed to represent trade secrets. In addition. this filina also includes: 6. Instructions for Use 7. Artwork for Product Labels 8. External Device Photographs Under the provisions of FCC Public Notice DA 04-1705, dated 15-Jun-04, Philips Medical Systems hereby requests that items 6-8 listed above be granted 45-day Limited Confidentiality from public disclosure, as the information is deemed to represent commercial secrets. If for some reason, the Commission cannot provide the Indefinite and limited Confidentialities as requested above, please contact me, and please insure that no material is placed into the public domain until we have had a chance to discuss this issue. Thank you in advance for your consideration of this application. I can be reached at (978) 659- 7383 or bye-mail to: [email protected]. If I am not available, please contact Ms. Denise Haley at (978) 659-4358 or bye-mail to: [email protected]. 3000 Minuteman Road Andover, Massachusetts 01810 Tel: (978) 687 1501, Fax: (978) 794 7646 www.philips.com e

Philips Medical Systems To: Date: From: Subject: Federal Communications Commission, Washington, DC 2055~ Attention: Ms. Jaunice Green September 22, 2004 Barry Wyshogrod, Philips Medical Systems, Andover, MA Reply to Correspondence Reference #27587 731 Application #EA237745 Dear Ms. Green and FCC Reviewers. On 14-SeD-O4. YOU e-mailed me the followina reQuest: Submit a drawing or photograph of the identification label. Reference Section 2.925(a). If a drawing is submitted, it must he accompanied by a sketch showing where it will be placed on the equipment. Phil iDS Medical Svstems'resoonse: I hereby submit two new attachments to our EA237745 submission: 1. 2. Revised artwork for the M2601 B product label. A revised photograph of the M2601 B product, with handwritten correction attesting to the intended .PQCM2601 Bu FCC ID label. Under the provisions of FCC Public Notice DA 04-1705, dated 15-Jun-O4, Philips Medical Systems hereby requests that these two items be granted 45-day Limited Confidentiality from public disclosure, as the information is deemed to represent commercial secrets. Thank you in advance for your continued consideration of our application. For any further issues, I can be reached at (978) 659-7383 or bye-mail to: [email protected];m. If I am not available, please contact Ms. Denise Haley at (978) 659-4350 or bye-mail to: [email protected]. Sincerely yours, ~~7~ Barry Wyshogrod Regulatory Engineer 3000 MI- p.Q8d An~r. MUAchuseas 01810 T8: (978) 687 ISO I. fix: (978) 794 7~ _.phillps.com e

Page 1 of 2 To: Federal Communications Commission, Washington, DC 20554 Attention: Ms. Diane Poole Date: October 28, 2004 From: Barry Wyshogrod, Philips Medical Systems, Andover, MA Subject: Reply to Correspondence Reference #27861 731 Application #EA237745 Dear Ms. Poole and FCC Reviewers, On 25-Oct-04, you e-mailed me the following requests: 1. Please add the FCC statement on the label as in 15.19 (a) of the FCC rules to the product. 2. Please submit a revised Confidentiality letter (for short term and long term confidential). Philips Medical Systems’ response to Item #1 above: Diane, as you and I clarified in our phone conversation, the radio portion of the PQCM2601B device does not contain any radio receiver; it is a transmitter only. And given that the remainder of the device is a specialized medical digital device, it is exempt from bearing the 47 CFR Part 15.19(a) label. Therefore, as we agreed by phone, the device will not bear this FCC statement. That said, I hereby attach a revised FCC ID Label for your records. Please delete all previous ID Label attachments and use this one (I had previously submitted a label as part of our reply to Correspondence #27587 on 22-Sep-04). Philips Medical Systems understands and agrees that this new FCC ID Label will not be held confidential. Philips Medical Systems’ response to Item #2 above: Philips is no longer requesting Confidentiality for the FCC ID Label mentioned above. However, as discussed in my phone conversations with you, Diane, Philips Medical Systems hereby submits a revised Request for Confidentiality, which supersedes our previous request dated 30- Aug-04. The new Request for Confidentiality distinguishes between Indefinite Confidentiality and 45-day Limited Confidentiality, and itemizes our request for the appropriate type for specific attachments to our submission. Indefinite Confidentiality is important to protect Trade Secrets. Limited Confidentiality is important for Philips Medical Systems from a commercial perspective. It enables the company to complete its development and regulatory efforts prior to introducing the product to the marketplace. Releasing information on the product via the FCC website prior to formal market introduction can be confusing to our customers and to the medical community, and places the company at a competitive disadvantage. Therefore, I hereby attach two new attachments to our EA237745 submission: 1. Revised FCC ID label artwork for PQCM2601B. 2. Revised Request for Confidentiality. Diane, thank you for your help and guidance. For any further issues, I can be reached at (978) 659-7383 or by e-mail to: [email protected] . If I am not available, please contact Philips Medical Systems Page 2 of 2 Ms. Denise Haley at (978) 659-4358 or by e-mail to: [email protected]. Sincerely yours, Barry Wyshogrod, Regulatory Engineer Signature already on-file at the FCC

To: Federal Communications Commission, Washington, DC 20554 Date: October 28, 2004 From: Barry Wyshogrod, Philips Medical Systems, Andover, MA Subject: Application for Radio Grant for M2601B, 731 Confirmation Number: EA237745 REVISED REQUEST FOR CONFIDENTIALITY – Replaces 30-Aug-04 version Dear Sir or Madam, Philips Medical Systems has submitted an application for Equipment Authorization under 47 CFR Part 95, Subpart H for a wireless medical telemetry transmitter, Model M2601B. The filing includes: 1. Block Diagram 2. Functional Description 3. Schematics 4. Bill of Material 5. Internal Device Photograph 6. External Device Photograph 7. Instructions for Use 8. Part 95 Test Report 9. FCC ID Label Under the provisions of Section 0.457(d) of the Commission’s Rules, and Section 552(b)(4) of the Freedom of Information Act, Philips Medical Systems hereby requests that items 1-4 listed above be granted Indefinite Confidentiality from public disclosure, as this information is deemed to represent trade secrets. Under the provisions of FCC Public Notice DA 04-1705, dated 15-Jun-04, Philips Medical Systems hereby requests that items 5-7 listed above be granted 45-day Limited Confidentiality from public disclosure. Limited Confidentiality is important for Philips Medical Systems from a commercial perspective. It enables the company to complete its development and regulatory efforts prior to introducing the product to the marketplace. Releasing information on the product via the FCC website prior to formal market introduction can be confusing to our customers and to the medical community, and places the company at a competitive disadvantage. To summarize: Indefinite Confidentiality 45-day Limited Confidentiality No Confidentiality Block Diagram Internal Device Photograph Part 95 Test Report Functional Description External Device Photograph FCC ID Label Schematics Instructions for Use Bill of Material Thank you in advance for your consideration of this application. I can be reached at (978) 659- 7383 or by e-mail to: [email protected] . If I am not available, please contact Ms. Denise Haley at (978) 659-4358 or by e-mail to: [email protected]. Sincerely yours, Barry Wyshogrod, Regulatory Engineer Signature already on-file at the FCC Philips Medical Systems

Page 1 of 1 To: Federal Communications Commission, Washington, DC 20554 Attention: Ms. Diane Poole Date: November 10, 2004 From: Barry Wyshogrod, Philips Medical Systems, Andover, MA Subject: Reply to Correspondence #28009 731 Application #EA237745 Dear Ms. Poole and FCC Reviewers, On 9-Nov-04, you e-mailed me the following request: Please resubmit the statement of compliance with 2.1093(c) and 95.1125. Philips Medical Systems’ response: Philips Medical Systems hereby asserts compliance to 47 CFR Parts 2.1093(c) and 95.1125, as per the attached RF Exposure statement. This cover letter and associated statement replace and supersede our previous cover letter and statement submitted on 29-Oct-04. Diane, thank you for your help. For any further issues, I can be reached at (978) 659-7383 or by e-mail to: [email protected] . If I am not available, please contact Ms. Denise Haley at (978) 659-4358 or by e-mail to: [email protected]. Sincerely yours, Barry Wyshogrod, Regulatory Engineer Signature already on-file at the FCC Philips Medical Systems

Page 1 of 1 RF Exposure Statement Philips Medical Systems hereby declares that the Wireless Medical Telemetry Device, M2601B (FCC ID: PQCM2601B) is compliant to 47 CFR §95.1125 and §2.1093(c) of the FCC rules, as verified by measurement. Barry Wyshogrod, Regulatory Engineer Signature already on-file at the FCC Submitted 10-November-2004 Philips Medical Systems

TEST NUMBER - 236-04 TEST REPORT TO FEDERAL COMMUNICATIONS COMMISSION CFR47 PART95 RSS-210 6.2.2(L3) 608-614 MHz (Medical Telemetry) Low Power Licensed Radio communication Devices Medical Telemetry Service Transceiver In the band 608-614 MHz for Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Drive Andover, MA 01810 978-659-2800 of Patient Worn Device ECG/SpO2 Narrowband FM Transceiver Model M2601B on 5/13/2004 Reviewed by -Il~ ~~~ 25 - Au,9 - O-Li Clifton PBrick This report may not be duplicated from Compliance Worldwide, Inc. except in full without written permission Compliance Worldwide, Inc. - 357 Main Street - Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com Page 2 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 TABLE OF CONTENTS • Test Description • Test Results and Conclusions • Test Procedures • Part 95 Test Limits • Test Facility Description • Test Setup and Connection Information • Test Measurements and Results Radiated Measurements Radiated Output Power & Occupied Bandwidth Conducted Measurements • Notes and Comments Page 3 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 TEST DESCRIPTION 1. TEST OBJECTIVE To test the Patient Worn Device with ECG and SpO2 transceiver Model M2601B to FCC Part 95 Rules and write a report. 2. E.U.T. DESCRIPTION GENERAL The Patient Worn Device with ECG and SpO2 Transceiver Model M2601B is an ECG and SpO2 monitoring device that provides an RF link to a monitoring station. MODULATION SCHEME: FM SERIAL NUMBERS: US41101374 608.0125 MHz US41101439 613.9875 MHz Page 4 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 TEST RESULTS AND CONCLUSIONS Rule Section Requirement Notes Pass Fail 95.1109(b) Labeling See Exhibits FCC Label Sample and Label Location. 1 95.115(a) Field Strength Limits X 95.115(b) Undesired Emissions Limits X 95.115(c) Emission Type Transmits Data and ECG Waveform X 95.115(e) Frequency Stability Data Provided By Philips Medical 1 95.1125 RF Safety Statement and Technical Basis 1 Note 1.) Exhibits provided by Philips for approval submission. Page 5 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 TEST RESULTS AND CONCLUSIONS PRODUCT TESTED - Patient Worn Device ECG/SpO2 Transceiver MODEL NUMBER - M2601B RADIATED TEST RESULTS The test results show that the emissions radiated from this equipment are in compliance with FCC Rules Part 95. OCCUPIED BANDWIDTH & OUTPUT POWER The test results show that the occupied bandwidth and output power of this equipment are in compliance with FCC Rules Part 95 . CONDUCTED TEST RESULTS N/A ANALYSIS AND CONCLUSIONS Based upon the radiated and conducted measurements we find that this equipment is within the limits of the FCC Rules Part 95. All results are based on a test of one sample, and represent other production units, only in as much as a sample represents other production units. If any significant changes are made to the unit, the changes shall be evaluated and a retest may be required. NOTES (Special conditions unique to this test) The EUT is battery Powered; no power line conducted testing applies. A full investigation of the spectrum of this devices digital circuitry can be found in Test report 236-04B. Page 6 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 TEST PROCEDURES 1. TEST EQUIPMENT A. HP 8546A (9 kHz - 6.5 GHz) EMI Receiver w/ RF Filter Section, S/N 3704A00323 / 3650A00360. Calibration Date 1-16-2004, calibrated annually. B. Com-Power Biconilog Antenna, Model AC220, S/N 25509. Calibration Date 7-17-2003, calibrated annually. C. Electro-Metrics Double Ridged Guide Antenna, Model EM-6961, S/N 6337. Calibration Date: 6-24-2003, calibrated annually. D. EMCO LISN, Model EM 3825/2, S/N 9109-1860. Calibration Date: 3-10-2004, calibrated annually. 2. FREQUENCY RANGE TO BE SCANNED. A. Radiated Test from 30 MHz to 40 GHz (or the 10 th harmonic of the highest frequency whichever is lower). B. Conducted Test from 150 kHz to 30 MHz. Page 7 of 22 Compliance Worldwide, Inc. – 357 Main Street – Sandown, NH 03873 (603) 887 3903 Fax 887 6445 http://www.cw-inc.com TEST NUMBER - 236-04 3. TEST PROCEDURES. Radiated test procedure: The EUT, associated cables and peripheral devices are placed on the supporting table and any support equipment is placed off the site. The EUT is turned on and any necessary operating or test software installed and allowed to warm up. The EUT is pre-scanned in our ferrite tile lined chamber where it is rotated 360 degrees and examined in both horizontal and vertical polarization, all emission frequencies are identified and recorded. The EUT is then moved to the OATS and the frequency band from 30 MHz to 40 GHz is scanned, all frequencies identified in the chamber are investigated, as well as harmonic frequencies of the EUT. When an emission is found the emission is maximized by varying the bundle position of the connecting cables, the antenna height, the antenna polarization (vertical and horizontal) and the table orientation (360 degrees). The maximum reading is recorded and the next signal is searched for. Conducted test procedure: The power line of the EUT is connected to the LISN (Line Impedance Stabilization Network). A measurement of the emissions are made from the power line for both phase and neutral on the analyzer in the frequency range from 150 kHz to 30 MHz. The maximum readings are recorded for each phase. All measurements are made according to the procedures defined in: "ANSI C63.4-1992 Standard Methods of Measurement of Radio Noise Emissions from Low-Voltage Electrical an…

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