PQC-CLNBPBV1Intellivue CL NBP Pod

Draft Instructions for Use IntelliVue Cableless Measurements IntelliVue CL SpO2 Pod and CL NBP Pod Release A.0 Patient Monitoring Part Number 453564199661 Printed in Germany 07/10 *453564199661* 3 1Table of Contents 1Introduction and Basic Operation7 Introducing the IntelliVue Cableless Measurements8 Operating and Navigating11 Operating Modes15 Using the Patient Menu16 Using Profiles17 Setting the Date and Time17 Charging IntelliVue Cableless Measurement Devices17 2Monitoring with the IntelliVue Cableless Measurements19 IntelliVue Cableless Measurements Use Models19 Assigning an IntelliVue Cableless Measurement Device to a Patient Monitor or Telemetry Device20 Controls Available with a Patient Monitor22 Controls Available With a Telemetry Device23 3Monitoring SpO225 SpO2 Sensors25 Connecting SpO2 Sensors26 Applying the Sensor27 Measuring SpO228 Selecting Measurement Modes28 Understanding SpO2 Numerics and Symbols29 Assessing a Suspicious SpO2 Reading30 Changing the Averaging Time30 Understanding SpO2 Alarms30 Perfusion Numeric (only available on the Patient Monitor)31 4Monitoring NBP33 Introducing the Oscillometric NBP Measurement33 Preparing to Measure NBP35 Starting and Stopping Measurements36 Enabling Automatic Mode and Setting Repetition Time37 Enabling Sequence Mode and Setting Up The Sequence37 Understanding the NBP Numerics and Symbols38 Correcting the Measurement if Limb is not at Heart Level38 Switching Pulse from NBP On/Off38 Assisting Venous Puncture39 Calibrating NBP39 4 5Technical Alarms (INOPs)41 Display of INOPs41 Acknowledging an INOP41 Displaying a List of Current INOPs41 Setting the Volume of the INOP Tone42 Reference List of all INOPs42 6Care and Cleaning47 General Points47 Cleaning and Disinfecting the IntelliVue Cableless Measurements48 7Maintenance and Troubleshooting51 Inspecting the Equipment and Accessories51 Maintenance Task and Test Schedule51 Troubleshooting52 Disposing of the IntelliVue Cableless Measurement Devices52 8Integrated Battery Handling53 Battery Care53 Handling Precautions53 Storage54 Battery Lifetime Management54 9Accessories55 IntelliVue CL SpO2 Pod Accessories55 IntelliVue CL NBP Pod Accessories56 Miscellaneous Accessories57 10Specifications59 Intended Use59 Manufacturer's Information59 Symbols60 Installation Safety Information61 Safety Specifications61 EMC And Radio Regulatory Compliance61 IntelliVue CL SpO2 Pod Specifications63 IntelliVue CL NBP Pod Specifications65 Alarm Specifications68 Telemetry Device Battery Runtime Specifications69 IntelliVue CL Charging Station Specifications69 IntelliVue CL Transmitter Base Station Specifications70 Safety and Performance Tests72 Electromagnetic Compatibility (EMC) Specifications72 Accessories Compliant with EMC Standards72 Electrosurgery Interference/Defibrillation72 5 Index73 6 1 7 1Introduction and Basic Operation These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their respective accessories together with IntelliVue Patient Monitors MP5/MP5T, MP2 or X2 or with the IntelliVue Telemetry System Transceiver TRx4841A/TRx4851A for monitoring and recording arterial oxygen saturation, pulse rate and non-invasive blood pressure of adult and pediatric patients. This section gives you an overview of the cableless measurements and how they are used. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment. Familiarize yourself with all instructions including warnings and cautions, and attend one of the training courses, before starting to make measurements with patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here. When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor or the telemetry system, refer to and adhere to all warnings in the Instructions for use of the respective device. In this guide: •A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. •A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO 2 Pod and IntelliVue CL NBP Pod with their accessories and auxiliary devices such as the IntelliVue CL Charging Station. Display refers to the physical display of the CL device. Screen refers to everything you see on the IntelliVue CL measurement's display, such as measurement values, patient data and so forth. 1 Introduction and Basic Operation 8 Introducing the IntelliVue Cableless Measurements The IntelliVue Cableless Measurements family consists of the following components and their respective accessories: The cableless measurement devices provide measurement values on the built-in display and communicate them to other system components using a wireless short range radio (SRR) interface. They can also be controlled via SRR from an assigned patient monitor or an IntelliVue Information Center via a telemetry device. They have an LCD display and three keys for basic operation e.g. to assign the device to a patient. IntelliVue CL SpO 2 PodIntelliVue CL NBP Pod IntelliVue CL Charging Station 1 Introduction and Basic Operation 9 IntelliVue CL SpO2 Pod The IntelliVue CL SpO 2 Pod is a battery powered, cableless Pulse Oximetry measuring device. It is a wrist-worn device; you need a Mobile CL SpO 2 Cradle to hold the sensor connector in place and a wristband to fix the cradle to a patient's arm. Specialized single-patient SpO 2 sensors are available for use with the IntelliVue CL SpO 2 Pod…

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CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 25 of 38 9 Ph otog ra ph s of th e EUT Photo documentation: external photos Photo 1: Photo 2: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 26 of 38 Photo 3: Photo 4: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 27 of 38 Photo 5: Photo 6: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 28 of 38 Photo 7: Photo 8:

CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 30 of 38 Photo documentation: internal photos Photo 1: Photo 2: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 31 of 38 Photo 3: Photo 4: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 32 of 38 Photo 5: Photo 6: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 33 of 38 Photo 7: Photo 8: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 34 of 38 Photo 9: Photo 10: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 35 of 38 Photo 11: Photo 12: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 36 of 38 Photo 13: Photo 14: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 37 of 38 Photo 15: Photo 16: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 38 of 38 Photo 17: Photo 18:

CETECOM ICT Services GmbH Untertürkheimer Straße 6-10 . D-66117 Saarbrücken Phone: +49 (0) 681-598-0 Fax: -9075 RSC-Laboratory 2010-09-07 Page 1 of 57 Accredited testing-laboratory DAR registration number: DGA-PL-176/94-D1 Federal Motor Transport Authority (KBA) DAR registration number: KBA-P 00070-97 Recognized by the Federal Communications Commission Anechoic chamber registration no.: 90462 (FCC) Anechoic chamber registration no.: 3462C-1 (IC) Certification ID: DE 0001 Accreditation ID: DE 0002 Accredited Bluetooth ® Test Facility (BQTF) The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Cetecom ICT is under license Test report no. : 1-1775-01-28/09 Type identification : IntelliVue CL NBP Pod Applicant : Philips Medizin Systeme Böblingen GmbH FCC ID : PQC-CLNBPBV1 IC Certification No : 3549C-CLNBPBV1 Test standards : 47 CFR Part 2 47 CFR Part 15 RSS – 210 Issue 7 CETECOM ICT Services GmbH Test report no.: 1-1775-01-28/09 2010-09-07 Page 2 of 57 Table of contents 1 G e n e r a l i n f o r m a t i o n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . 3 1.1 Notes ...................................................................................................................................................................3 1.2 Testing laboratory ...............................................................................................................................................4 1.3 Details of applicant .............................................................................................................................................4 1.4 Application details ..............................................................................................................................................4 2 T e s t s t a n d a r d / s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . 5 3 T e c h n i c a l t e s t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . 6 3.1 Details of manufacturer .......................................................................................................................................6 3.1.1 Test item......................................................................................................................................................6 3.1.2 Additional EUT information For IC Canada (appendix 2)..........................................................................7 3.1.3 EUT operating modes..................................................................................................................................8 3.1.4 Extreme conditions testing values ...............................................................................................................8 4 S u m m a r y o f M e a s u r e m e n t R e s u l t s a n d l i s t o f a l l p e r fo r m e d t e s t c a s e s . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5 R F m e a s u r e m e n t t e s t i n g . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . 1 0 5.1 Description of test setup ....................................................................................................................................10 5.1.1 Radiated measurements.............................................................................................................................10 5.1.2 Conducted measurements..........................................................................................................................10 5.2 Referenced documents ......................................................................................................................................11 5.3 Additional comments ........................................................................................................................................11 5.4 Antenna gain .....................................................................................................................................................12 5.5 Carrier frequency separation §15.247(a)(1) ......................................................................................................12 5.6 Number of hopping channels §15.247(a)(1) .....................................................................................................12 5.7 Time of occupancy (dwell time) §15.247(a)(1)(iii)...........................................................................................12 5.8 Power Spectral density (Hybrid system in Inquiry mode/Page scan) §15.247(e) .............................................13 5.9 Spectrum Bandwidth of a FHSS System 6/20dB Bandwidth §15.247(a)(1).....................................................15 5.10 Maximum output power (conducted) § 15.247 (b)(1) ...................................................................................19 5.11 Max. peak output power (radiated) § 15.247 (b)(1) ......................................................................................21 5.12 Band-edge compliance of conducted emissions §15.247 (d) ........................................................................23 5.13 Band-edge compliance of radiated emissions §15.205 .................................................................................25 5.14 Spurious Emissions - conducted (Transmitter) § 15.247 (c)(1) ....................................................................26 5.15 Spurious Emissions >…

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CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 23 of 38 8 Ph otog ra ph s of th e Test S et-up Photo documentation: Photo 1: Photo 2: CETECOM ICT Services GmbH Test report no.: 1-2197-01-03/10 2010-05-03 Page 24 of 38 Photo 3: Photo 4: