BQI02DR-10100WMTS OPENNET LAN

WMTS TRANSCEIVERS PatientNet Operator’s Manual, v1.04, 10001001-003, Revision B 183 All information contained herein is subject to the rights and restrictions on the title page. WMTS TRANSCEIVERS Note:The information in this section is only applicable for Wireless Medical Telemetry Service (WMTS). About Transceivers Wireless Medical Telemetry Services (WMTS) Remote Transceivers provide the link between the patient and the Central Station through the newly approved 608 - 614 MHz Medical Telemetry frequency band. The ambulatory and bedside device trans- ceivers communicate data to the Central Station through the Access Point transceiver. In addition, the transceivers are capable of receiving control commands for self-use or connection transfer. The PatientNet ambulatory transceiver is the DT-4500. This transceiver is worn by the patient and usually carried in a gown pocket or pouch, and used with a 3, 4, or 5-wire leadset connected to the electrodes on the patient. The DT-4500 is IPX7 compliant, so it can be submerged in 1m of water for up to 30 minutes. The DT-7000 and DT-7001 are the PatientNet bedside-device transceivers and are physically connected to bedside monitors (other manufacturers’ bedside monitors and NPB 7200 series ventilator). The DR-10000 Access Point transceiver collects data from the ambulatory and bed- side transceivers, sends that data to the Central Station, and transmits control data to the transceiver devices. WARNING: Remove transceivers from patients before MRI and CAT scan procedures, and store the transceivers outside the room where such equipment is located. Close proximity to MRI or CAT scan equipment may result in damage to transceivers. Programming Transceivers Before a transceiver can be used with the PatientNet System, it must first be pro- grammed with a Network Number and Monitor I.D. number to match the correspond- ing Central Station. Consult your facility’s system administrator to perform these functions. WARNING: When programming the DT-4500 through the External Serial Device (I/O) con- nector, it must be disconnected from the patient. The accessory connector shall be kept covered when not in use with the supplied protective cover. Failure to follow these instructions could lead to excessive voltages and cur- rents being applied to the patient, resulting in cardiac arrest. The corresponding Central Station must also be programmed to this Network Number and Monitor Identification number. If you have any questions about the programming status, contact your system adminis- trator. WMTS TRANSCEIVERS 184 PatientNet Operator’s Manual, v1.04, 10001001-003, Revision B All information contained herein is subject to the rights and restrictions on the title page. Displaying Transceiver Status You can view transceiver status on the Central Station, but not on the PatientNet Viewers (also known as the IRVS and RVS). 1. Press System on the Main screen. 2. Press OpenNet button on the Passcode screen to display the OpenNet Status screen (fig. 90). Fig. 90. OpenNet Status screen Your System Administrator enables or disables the Assign TX, Program AT, and Program IT buttons. Check with your System Administrator for more information. The columns in the OpenNet Status screen are described below. Ch channel number Module ID Transceiver ID that the channel is currently set to Device ID Device ID of the transceiver from which the channel receives data Batt battery voltage of the ambulatory transceiver LL left leg electrode impedance value RA right arm electrode impedance value LA left arm electrode impedance Va chest electrode impedance value Vb, Vc miscellaneous electrode impedance value Freq Resp frequency response programmed into each transceiver Link link between the transceiver and the Central Station: OK: the Central Station is receiving data from the transceiver OFF: the Central Station is not receiving data Device Type transceiver or bedside monitor associated with the channel Version TX the download firmware version currently in the transceiver Version RX the RF Module firmware version currently in the transceiver Ch channel number WMTS TRANSCEIVERS PatientNet Operator’s Manual, v1.04, 10001001-003, Revision B 185 All information contained herein is subject to the rights and restrictions on the title page. Impedance Values The DT-4500 Ambulatory Transceivers electrode impedance values, which are displayed on the OpenNet Transceiver Status screen, indicate the quality of the signal connection and are not the actual impedance values that are measured by the system. The electrode impedance values range from 100 to 200 (optimal). The typical values range between 180 and 200. If the electrode’s impedance value is greater than the defined Quality Threshold value, then its LED is illuminated. The DT-4500 stores the Quality Threshold value and uses this value to determine whether or not the electrode LED should be illuminated when the Attendant Present buttons are pressed. See Figure 91 on page 190 for details on the DT-4500 Buttons and LED indicators. Note:A Lead Off alarm will occur when an electrode’s impedance value drops to 150 (150 is the default Loose Lead Threshold value). User Warnings, Cautions, and Notes Before operating the WMTS transceivers, read and follow all warnings and cautions presented in this section. Warnings 1. Do not use the output of the DT-4500 as a synchronization source for car- diac defibrillation. Delays in presentation of the R-Wave may be as much as 40 milliseconds. 2. Do not monitor pacer patients with a 3 wire leadset when reliable pacer detection is required. Pacer pulse detection can be erratic when only a single vector is monitored. Always use a 5 wire leadset when reliable pacer detection is required. 3. The DT-4500 is a type BF patient applied device. It is not suitable for direct cardiac application, for use in the operating room, or during car- diac surgery. Use in these environments could cause hazardous voltages and currents bein…

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FCC ID: BQI02DR-10100

American Telecommunications Certification Body Inc. 6731 Whittier Ave, McLean, VA 22101 December 12, 2002 RE: FCC ID: BQI02DR-10100 Attention: I have a few comments on this Application. 1 The manufacturer will have to provide a letter attesting to the fact that he will include all modifications made during testing in the final product. 2 Since a ferrite is required for compliance of this device, the ferrite on the Ethernet cable must be provided with the product and instructions on how to install it need to be in the manual. Alternately, the Ethernet cable with ferrite must be provided with instructions for installtion 3 You refer to ANSI C63.4 for testing. Please note that while ANSI would apply to the Digital part only. Testing of the licensed device would not be to ANSI C62.4. Please verify that Part 95 testing was done to the appropriate test method and please remove ANSI C63.4 reference to the transmitter testing. 4 Please note, as of Oct 16, 2002 Part 15.241 and 15.242 are non-existent for this type device. You have properly tested to Part 95 H, but you have referenced non-existent Part 15 sections in your report. These need to be removed from the report. Please provide a revised report removing reference to ANSI C63.4 as a measurement method for this transmitter. 5 The modifications done on the digital board do not appear to have been made to the schematics. Please make sure that in the letter from the manufacturer attesting to incorporate the modifications made during testing they also attest to making the proper changes in the schematics. Please provide this revised schematic as soon as possible. 6 FYI, no action needed. Please note that this is a licensed device and as such ANSI C63.4 measurement techniques do not apply. Please note that spurious emissions above 1GHz are specifically stated as being measured in accordance with 95.1115(b)(2), which states, “Out-of- band emissions above 960 MHz are limited to 500 uV/m as measured at a distance of 3 meters using measuring equipment with an averaging detector and a 1 MHz measurement bandwidth.. Historically the FCC has done the pulse width modulation for pulsed devices such as this for obvious reasons, but technically the rules do not accept this measurement technique. Dennis Ward mailto:[email protected] The items indicated above must be submitted before processing can continue on the above referenced application. Failure to provide the requested information may result in application termination. Correspondence should be considered part of the permanent submission and may be viewed from the Internet after a Grant of Equipment Authorization is issued. Please do not respond to this correspondence using the email reply button. In order for your response to be processed expeditiously, you must submit your documents through the AmericanTCB.com website. Also, please note that partial responses increase processing time and should not be submitted. Any questions about the content of this correspondence should be directed to the sender.

Answers to questions posed by TCB reviewer, 1) The manufacturer will have to provide a letter attesting to the fact that he will include all modifications made during testing in the final product. The modifications needed to bring this unit into compliance have been incorporated into our work instructions for this product and are part of the official release package - i.e. the product cannot be shipped without the modifications in place. 2) Since a ferrite is required for compliance of this device, the ferrite on the Ethernet cable must be provided with the product and instructions on how to install it need to be in the manual. Alternately, the Ethernet cable with ferrite must be provided with instructions for installation. The ferrite bead is included in the packing box with the product. A single-sheet document is included as well indicating how and where the ferrite bead should be installed on the product. 5) The modifications done on the digital board do not appear to have been made to the schematics. Please make sure that in the letter from the manufacturer attesting to incorporate the modifications made during testing they also attest to making the proper changes in the schematics. Please provide this revised schematic as soon as possible." As indicated before, the modifications needed to bring the product into compliance are listed on work instructions associated with the product. The modifications must be made before the product can ship. Note that a copy of the additions and modifications was included in submitted package. Additionally, these changes affect the digital device board which was not required to be submitted in the application and was therefore not provided. The schematics provided in the application are strictly the Transceiver and RF path schematics. In our engineering configuration system, a schematic can only show those items on the PWB that rest atop normal PCB pads. Items added afterwards by hand, such as these modifications, cannot show up on our schematics since they do not have PWB pads associated with them. In our system, the documentation for the additional modifications comes in the form of engineering change orders or specific work instructions. At some point in the near future, we expect to re-layout the PWB and place the current hand modified circuits onto the PWB proper. We will have the product re-measured by our test lab to ensure that the unit is still in compliance. It is at that point, with the modifications formally in place on the PWB, that the schematic will reflect the modifications that have been put in place. Mark Tucker VP of Engineering Cirronet 12/13/02

FCC ID: BQI01DR-10100 Photo 1. EUT, Front View FCC ID: BQI01DR-10100 Photo 2. EUT, Rear View These ports not used in this version of the device

FCC ID: BQI01DR-10100 Photo 11. Patch Antenna, Top View FCC ID: BQI01DR-10100 Photo 12. Patch Antenna, Bottom View FCC ID: BQI01DR-10100 Photo 13. Whip Antenna

FCC ID: BQI02DR-10100 FCC ID: BQI01DR-10100 Label

FCC ID: BQI01DR-10100 Photo 3. EUT, Top View, Cover Opened FCC ID: BQI01DR-10100 Photo 4. EUT, Top View, Cover Opened, Transceiver Removed FCC ID: BQI01DR-10100 Photo 5. EUT, Bottom View, Cover Opened FCC ID: BQI01DR-10100 Photo 6. EUT, Transceiver Module, Top View FCC ID: BQI01DR-10100 Photo 7. EUT, Transceiver Module, Bottom View FCC ID: BQI01DR-10100 Photo 8. EUT, Internal View of Shield Cover FCC ID: BQI01DR-10100 Photo 9. EUT, Top View of Transceiver Board FCC ID: BQI01DR-10100 Photo 10. EUT, Bottom View of Transceiver Board

FCC ID: BQI01DR-10100 7.0 RF Safety Requirements to 2.1091/95.1125 for Mobile Transmitters Part 95 transmitters are considered categorically excluded from routine environmental evaluation as given in 47 CFR 2.1091. However, the following information is presented to prove compliance with the limits. Power Output The EUT’s maximum output power as measured directly from the transmitter module is +12.0 dBm (15.8 mW). The EUT may utilize 2 different types of antenna’s (patch @ + 2 dBi, monopole @ 0 dBi). Frequency of Fundamental (MHz) Measurement (Watt)* Antenna Gain (dBi) P ERP (Watt) 608.6656- 612.898133 0.01582.00.0251 Source Based Time Averaging Source Time Averaging has not been evaluated regarding this product. MPE Calculations The limits for this unit (uncontrolled exposure) are 0.4 mW/cm 2 . Taking the RF Density Field Equation: S = (EIRP in mW)/(4πR 2 ) and solving for Distance R R = SQRT (EIRP in mW)/(S4π) Solving the above equation yields R (cm) = SQRT (25.1(mw))/(0.4(mW/cm 2 )*4*π) = 5.0 cm Since the EUT is designed only for mobile applications (where the expected separation distance between antenna and humans is greater than 20 cm), all manual instructions have specified 20 cm as the minimum exposure distance.

Data Critical Corporation FCC Part 95 Application Model DR-10100 December 5, 2002 FCC ID: BQI02DR-10100 MEASUREMENT/TECHNICAL REPORT COMPANY NAME:Data Critical Corporation MODEL:DR-10100 FCC ID:BQI02DR-10100 DATE:December 5, 2002 This report concerns (check one): Original grant X Class II change ____ Equipment type: Low Power Transmitter (for Biomedical Applications) Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? yes_____ No X If yes, defer until:_________________ date N.A. agrees to notify the Commission by N.A. date of the intended date of announcement of the product so that the grant can be issued on that date. Report prepared by: United States Technologies, Inc. 3505 Francis Circle Alpharetta, GA 30004 Phone Number: (770) 740-0717 Fax Number: (770) 740-1508 FCC ID: BQI02DR-10100 TABLE OF CONTENTS LETTER OF CONFIDENTIALITY SECTION 1 GENERAL INFORMATION Product Description SECTION 2 TESTS AND MEASUREMENTS Configuration of Tested Test Facility Modifications Test Equipment Modifications Antenna Description Field Strength of Fundamental Field Strength of Spurious Emissions Radiated Digital Device Emissions Power Line Conducted Emissions for Digital Device, Transmitter, and Receiver Emissions Type Frequency Stability SECTION 3 LABELING INFORMATION SECTION 4 BLOCK DIAGRAM(S)/SCHEMATICS SECTION 5 THEORY OF OPERATION SECTION 6 PHOTOGRAPHS SECTION 7 RF EXPOSURE INFORMATION SECTION 8 USER'S MANUAL FCC ID: BQI02DR-10100 LIST OF FIGURES AND TABLES FIGURES Test Configuration Photograph(s) for Fundamental, Spurious, and Digital Device Emissions Photograph(s) for Conducted Emissions Field Strength of Fundamental Emission Field Strength of Spurious Emissions TABLES EUT and Peripherals Test Instruments Field Strength of Fundamental Emission Field Strength of Spurious Emissions Radiated Digital Device Emissions Power Line Conducted Emissions for Digital Device, Transmitter, and Receiver FCC ID: BQI02DR-10100 SECTION 1 GENERAL INFORMATION FCC ID: BQI02DR-10100 GENERAL INFORMATION Product Description The Equipment Under Test (EUT) is a Data Critical Corporation, DR-10100. The DR-10100 is a wireless Access Point (AP) designed for use in medical monitoring applications. The DR-10100 receives patient monitoring data from similar radios (FCC ID: BQI00DT-4500) attached to the patients in that hospital. The DR-10100 is linked to other DR-10100's or DR-10000’s through a 10Base-T Ethernet backbone. This backbone allows the AP's to pass patient data back to the end user of the system - a nurses monitoring station. The DR-10100 is composed of a 608-614 MHz wireless transceiver and Ethernet conversion circuitry that passes data from the transceiver to the Ethernet backbone. The DR-10100 may operate with two different types of antennas: a 0 dBi monopole to provide omni-directional coverage and a +2 dBi patch antenna to provide unidirectional coverage. The unit requires external DC power but has its own internal voltage regulation. The DR-10100 is self contained in a plastic package and is designed to be installed on the ceiling of a hospital hallway. FCC ID: BQI02DR-10100 Related Submittal(s)/Grant(s) Additionally, the EUT will be used with other transceivers (already submitted and approved under FCC ID: BQIOODT-4500). FCC ID: BQI02DR-10100 SECTION 2 TESTS AND MEASUREMENTS FCC ID: BQI02DR-10100 TESTS AND MEASUREMENTS Configuration of Tested System The sample was tested per ANSI C63.4, Methods of Measurement from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (1992). Conducted and radiated emissions data were taken with the test receiver or spectrum analyzer's resolution bandwidth adjusted to 9 kHz and 120 kHz, respectively. All measurements are peak unless stated otherwise. The video filter associated with the spectrum analyzer was off throughout the evaluation process. Interconnecting cables were manipulated as necessary to maximize emissions. A block diagram of the tested system is shown in Figure 1. Test configuration photographs for spurious and fundamental emissions are shown in Figure 2. Test Facility Testing was performed at US Tech's measurement facility at 3505 Francis Circle, Alpharetta, GA. This site has been fully described and submitted to the FCC, and accepted in their letter marked 31040/SIT. Additionally this site has also been fully described and submitted to Industry Canada (IC), and has been approved under file number IC2982. Modifications To bring the EUT into compliance with FCC Part 95 limits for the transmitter portion of the EUT and the Part 15 Digital Device Requirements, the following modifications were made: 1) A ferrite was placed on the Ethernet Cable (Steward Part Number 28A2024-0A0). The following changes were made to the digital device board. 2) Changed R32 to 330 ohm. 3) Added a 0.01 uF to the VCC pin of Y1. 4) Added a 330 ohm resistor in series with output of Y1. 5) Added a shunt 56 pF capacitor to ground at "cold" side of the 330 ohm 6) Resistor added in series with Y1. 7) Inserted series Z-Beads in line with pins numbers 4, 5 and 7 of JP6. 8) Part number of bead is ETC1608-221. 9) Added 0.01 uF cap between pins 7 and 8 of JP6. 10)Added 0.01 uF cap between pins 7 and 8 of JP5. 11) Increased R64 to 330 ohms. 12) Added a 0.01 uF to ground from pin 14 of U4. 13) Added a 0.01 uF to ground from pin 14 of U7. 14) Added a termination consisting of two 50 ohm resistors and one 0.01 uF 15) Capacitor to pins 15 and 16 of U4. 16) Added a termination consisting of two 50 ohm resistors and one 0.01 uF 17) Added a capacitor to pins 15 and 16 of U7. FCC ID: BQI02DR-10100 Test Equipment Table 2 describes test equipment used to evaluate this product. FCC ID: BQI02DR-10100 FIGURE 1 TEST CONFIGURATION Transceiver (EUT) AC Adapter #1 Laptop Computer AC Adapter #2 Patch Antenna 120 VAC 60 Hz Direct Plug In 120 VAC 60 Hz 6' U 3' S 6’ S 1 m U Ethernet Term 6' U 3’ S 50 Ohm Term 6' S Printer 6’ U 6' U 120 VAC 60 Hz Αlternatively, the patch antenna and its cable may b…

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Data Critical Corporation FCC Part 95 Application Model DR-10100 December 5, 2002 FCC ID: BQI02DR-10100 MEASUREMENT/TECHNICAL REPORT COMPANY NAME:Data Critical Corporation MODEL:DR-10100 FCC ID:BQI02DR-10100 DATE:December 5, 2002 This report concerns (check one): Original grant X Class II change ____ Equipment type: Low Power Transmitter (for Biomedical Applications) Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? yes_____ No X If yes, defer until:_________________ date N.A. agrees to notify the Commission by N.A. date of the intended date of announcement of the product so that the grant can be issued on that date. Report prepared by: United States Technologies, Inc. 3505 Francis Circle Alpharetta, GA 30004 Phone Number: (770) 740-0717 Fax Number: (770) 740-1508 FCC ID: BQI02DR-10100 TABLE OF CONTENTS LETTER OF CONFIDENTIALITY SECTION 1 GENERAL INFORMATION Product Description SECTION 2 TESTS AND MEASUREMENTS Configuration of Tested Test Facility Modifications Test Equipment Modifications Antenna Description Field Strength of Fundamental Field Strength of Spurious Emissions Radiated Digital Device Emissions Power Line Conducted Emissions for Digital Device, Transmitter, and Receiver Emissions Type Frequency Stability SECTION 3 LABELING INFORMATION SECTION 4 BLOCK DIAGRAM(S)/SCHEMATICS SECTION 5 THEORY OF OPERATION SECTION 6 PHOTOGRAPHS SECTION 7 RF EXPOSURE INFORMATION SECTION 8 USER'S MANUAL FCC ID: BQI02DR-10100 LIST OF FIGURES AND TABLES FIGURES Test Configuration Photograph(s) for Fundamental, Spurious, and Digital Device Emissions Photograph(s) for Conducted Emissions Field Strength of Fundamental Emission Field Strength of Spurious Emissions TABLES EUT and Peripherals Test Instruments Field Strength of Fundamental Emission Field Strength of Spurious Emissions Radiated Digital Device Emissions Power Line Conducted Emissions for Digital Device, Transmitter, and Receiver FCC ID: BQI02DR-10100 SECTION 1 GENERAL INFORMATION FCC ID: BQI02DR-10100 GENERAL INFORMATION Product Description The Equipment Under Test (EUT) is a Data Critical Corporation, DR-10100. The DR-10100 is a wireless Access Point (AP) designed for use in medical monitoring applications. The DR-10100 receives patient monitoring data from similar radios (FCC ID: BQI00DT-4500) attached to the patients in that hospital. The DR-10100 is linked to other DR-10100's or DR-10000’s through a 10Base-T Ethernet backbone. This backbone allows the AP's to pass patient data back to the end user of the system - a nurses monitoring station. The DR-10100 is composed of a 608-614 MHz wireless transceiver and Ethernet conversion circuitry that passes data from the transceiver to the Ethernet backbone. The DR-10100 may operate with two different types of antennas: a 0 dBi monopole to provide omni-directional coverage and a +2 dBi patch antenna to provide unidirectional coverage. The unit requires external DC power but has its own internal voltage regulation. The DR-10100 is self contained in a plastic package and is designed to be installed on the ceiling of a hospital hallway. FCC ID: BQI02DR-10100 Related Submittal(s)/Grant(s) Additionally, the EUT will be used with other transceivers (already submitted and approved under FCC ID: BQIOODT-4500). FCC ID: BQI02DR-10100 SECTION 2 TESTS AND MEASUREMENTS FCC ID: BQI02DR-10100 TESTS AND MEASUREMENTS Configuration of Tested System Since Part 95 stipulates radiated field strength limits and not dBc limits. Therefore as allowed by 2.947(a)(3), the sample was tested per ANSI C63.4, Methods of Measurement from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (1992). Please note that the FCC has also shown a history of accepting other applications using ANSI C63.4 as the test methodology for devices tested under 95.1115. Conducted and radiated emissions data were taken with the test receiver or spectrum analyzer's resolution bandwidth adjusted to 9 kHz and 120 kHz, respectively. All measurements are peak unless stated otherwise. The video filter associated with the spectrum analyzer was off throughout the evaluation process. Interconnecting cables were manipulated as necessary to maximize emissions. A block diagram of the tested system is shown in Figure 1. Test configuration photographs for spurious and fundamental emissions are shown in Figure 2. Test Facility Testing was performed at US Tech's measurement facility at 3505 Francis Circle, Alpharetta, GA. This site has been fully described and submitted to the FCC, and accepted in their letter marked 31040/SIT. Additionally this site has also been fully described and submitted to Industry Canada (IC), and has been approved under file number IC2982. Modifications To bring the EUT into compliance with FCC Part 95 limits for the transmitter portion of the EUT and the Part 15 Digital Device Requirements, the following modifications were made: 1) A ferrite was placed on the Ethernet Cable (Steward Part Number 28A2024-0A0). The following changes were made to the digital device board. 2) Changed R32 to 330 ohm. 3) Added a 0.01 uF to the VCC pin of Y1. 4) Added a 330-ohm resistor in series with output of Y1. 5) Added a shunt 56 pF capacitor to ground at "cold" side of the 330 ohm 6) Resistor added in series with Y1. 7) Inserted series Z-Beads in line with pins numbers 4, 5 and 7 of JP6. Part number of bead is ETC1608-221. 8) Added 0.01 uF cap between pins 7 and 8 of JP6. 9) Added 0.01 uF cap between pins 7 and 8 of JP5. 10) Increased R64 to 330 ohms. 11) Added a 0.01 uF to ground from pin 14 of U4. 12) Added a 0.01 uF to ground from pin 14 of U7. 13) Added a termination consisting of two 50 ohm resistors and one 0.01 uF 14) Capacitor to pins 15 and 16 of U4. 15) Added a termination consisting of two 50 ohm resistors and one 0.01 uF 16) Added a capacitor to pins 15 and 16 of U7. FCC ID: BQI02DR-10100 Test Equipment Table 2 describes test equipment used to evaluate this product. FCC ID: BQI02DR-10100 FIGURE 1 TEST CONFIGURATIO…

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FCC ID: BQI02DR-10100 FIGURE 2a Photograph(s) for Fundamental, Spurious and Digital Devices Emissions Dipole Configuration FCC ID: BQI02DR-10100 FIGURE 2b Photograph(s) for Fundamental, Spurious and Digital Devices Emissions Patch Configuration FCC ID: BQI02DR-10100 FIGURE 2c Photograph(s) for Conducted Emissions