QHQ-FST1908Vital Signs Simulator Transceiver

- 1 - VitalSim Directions for Use Overview and Intended use. The VitalSim Base Unit and Remote Control are intended to be used in conjunction with an approved manikin to simulate vital signs on the manikin. The system consists of a Base Unit, connecting to a manikin, and a radio controlled Remote Control for device operation. Both the Base Unit and the Remote Control are battery operated. The Base Unit can also be used with an AC wall adapter. VitalSim System includes: Carry Case Base Unit including battery case and batteries (6 C-cell) Remote Control including batteries (4 AA-cell) Remote Control to Base Unit connection cable USB cable for connection to PC DC power supply Direction for Use Operating Software on CD-ROM Important Information This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Consult the dealer or an experienced radio/TV technician for help. -- Increase the separation between the equipment and receiver. -- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -- Consult the dealer or an experienced radio/TV technician for help. Caution: Changes or modifications not expressly approved by Laerdal could void the user's authority to operate this equipment. Hereby, Laerdal Medical declares that when carrying the CE-mark, the VitalSim product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. - 2 - Use with Laerdal Manikins The VitalSim is designed to work with a variety of manikins manufactured by Laerdal. The manikins range from adult, child and infant advance life support manikins to nursing manikins. The VitalSim will detect which type of manikin is connected and adjust physiological and menu functions accordingly. Selection of manikin can be overridden from the Setup Menu. Features ECG/Defib/Pacing Extensive ECG library. Running rhythm and a Waiting Rhythm that can be activated on command or after a defibrillation External pacing detection with settable pacing threshold 20 – 200 mA External defibrillation (10-360 J), may affect preprogrammed scenario or lead to direct ECG rhythm change Heart, Lung, Bowel and Spoken Sounds Heart Sounds synchronized with ECG. Lung sounds synchronized with adjustable breathing rate, 0 – 60 BPM. Individual lung or bilateral sound selection. Normal and abnormal bowel sounds. Computer generated sounds, mixed with voice input via microphone. Blood Pressure Auscultated and palpated blood pressure simulator. Korotkoff sounds synchronized with ECG. Systolic and diastolic pressure individually settable in steps of 2 mmHg up to 300 mmHg. Auscultative Gap, On / Off feature. Calibration function. Palpated Pulses Controls Brachial, Radial, and Carotid pulses. Pulses synchronized with ECG and pulse strengths dependent on BP. Systolic BP can be palpated on radial pulse. Only 2 pulses active at a time, to save power. Brachial pulse turned off when BP cuff inflated (to avoid sound interference). Scenario Function Possible to program, upload, and run scenarios on the VitalSim Base Unit. Using a PC Scenario editor. Up to 10 programmable scenarios at one time. Logging Generate 25 logs for after action review. Log(s) can be retrieved by a PC through the USB connection - 3 - Overview VitalSim Base Unit A. On/Off button and Indicator. The button turns the unit on and initiates pre-set vital signs. Press once to turn the unit on. Press again to turn the unit off. The indicator is steady green if it has contact with the Remote Control. If there is no contact with the Remote Control the indicator will be blinking green. If battery needs to be replaced, the indicator will blink, alternating between green and orange. B. DC power supply: Use this feature for stationary training and to limit battery consumption. The DC power supply is supplied with VitalSim C. Manikin Connector: Connects the Base Unit to the manikin or peripheral accessories. Supplied with manikins. D. Microphone: External microphone attachment, sold separately. E. USB port: Used for downloading scenarios and up- loading of log’s. F. Remote connector: Used for direct communication with the Remote Control. G. Blood Pressure connector: Connects the blood pressure hose from BP-cuff. H. Battery: Holds (6) replaceable C-cell batteries. Overview VitalSim Remote Control The Remote Control communicates with the VitalSim Base Unit via a short-range radio link. Range from Remote control is approximately 10m / 30 ft. 5 Different channels can be selected to improve immunity to interference and allowing for use of several units within the same area. I. LCD display: Displays vital information and activated features such as ECG, Sounds, Blood pressure, Scenarios, Logging, etc. J. Function keys: Use these keys to implement quick functions, i.e. set Rate, Volume, PEA, activate waiting rhythm, etc. K. Navigation keys: Use these keys to navigate your way through programming…

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Laerdal VitalSim Control Unit Manikin Connector PC / USB BP Cuff Laerdal VitalSim Control Unit DC Input Control Unit Board Serial Port Line input (Audio) ECG Defibrillation Pacing Pulse: -Brachial - Radial -Carotid - Femoral Blood Pressure - Sounds - Pressure Sounds: - RL - LL - Heart - Bowel - Vocal DAC, ADC, Amplifiers, filters, drivers and sensors Radio link (for details; see schematics page 6) XTAL oscillator 14,7456MHz MCU Motorola Coldfire MCF5272 Main Oscillator: 66MHz USB Oscillator: 48MHz Memory (SDRAM and FLASH) ON/OFF logic Voltage regulators Battery (Replaceable)

Page 1 of 1 Laerdal VitalSim Control Unit External photos Laerdal VitalSim Control Unit. External photo FCC ID QHQ-FST1908

Page 1 of 1 Laerdal VitalSim Control Unit Labels Laerdal VitalSim Control Unit. Labels FCC ID QHQ-FST1908 Placement of labels on QHQ-FST1908 Product identification label Label with FCC statement

Page 1 of 2 Laerdal VitalSim Control Unit Internal photos Laerdal VitalSim Control Unit. Internal photo FCC ID QHQ-FST1908 View from front. Lid flipped backwards. Battery pack pulled out and shown top left. Print turned 90 deg right. The radio is at 10 cm mark. Antenna is following edge to the right. 2 of 2 Page 2 of 2 Laerdal VitalSim Control Unit Internal photos Laerdal VitalSim Control Unit. Internal photo FCC ID QHQ-FST1908 Solder-side of printed circuit board.

Laerdal VitalSim Control Unit Operational description VitalSim Control Unit is intended to control a patient simulator (training manikin) for health personnel. • Sound: The manikin is supplied with sound signals for 8 independent speakers • Pulse: The manikin may have up to 6 puls-units (linear motors). The pulse units are driven by pulse-width modulated signals supplied by the control unit. The Control unit also senses when pulse-units are palpated • ECG: Control unit supplies ECG-signals to the manikin (pulse-width modulated). Control unit senses defibrillation and pacing on the manikin. • Blood Pressure: Control unit measures the pressure in BP cuff, and supplies BP sound to the manikin based on the pressure. • User control: Laerdal Operating Device is the user control for the Control Unit Power Source: • 6 Alkaline batteries, C-cells or DC Input • Input voltage range:5,5V-13,6V RF: • The RF circuit is based on IC; Chipcon CC1000 • RF Frequency: 915,606-916,484MHz (5 channels) • IF frequency: 150 kHz (typ) • IF bandwidth: 175kHz (typ) • XTAL oscillator 14,7456MHz (20ppm) • Modulation: FSK Antenna: • Internal monopol (PCB track) • PCB contains 6 layers included ground plane and power plane. Interface: • Manikin Connector. Connection to training manikin. • PC/USB. Connection to PC for production and service usage (reprogramming) • Serial Port. Connection to Laerdal Operating Device. Alternative to RF interface. • Line Input. For audio equipment (e.g. wireless MIC) • BP Cuff. Cuff pressure inlet (not an electrical connection)

20dan-uk-i DELTA Danish Electronics, Light & Acoustics Venlighedsvej 4 2970 Hørsholm Denmark Tel. (+45) 72 19 40 00 Fax (+45) 72 19 40 01 www.delta.dk This report is issued under the rules of DANAK (Danish Accreditation). Further information about DANAK can be found at www.danak.dk. The report must not be reproduced, except in full, without the written approval of DELTA. Test Report DANAK Reg. no. 19 Emission tests to FCC requirements of Laerdal Control unit VitalSim and Power adapter for VitalSim Performed for Laerdal Medical DANAK-196771 Project no.: E500676-4 Page 1 of 13 5 annexes 2003-02-25 DANAK-196771 DELTA-E500676-4 Page 2 of 13 VS/AED Title Emission tests to FCC requirements of Laerdal Control unit VitalSim and Power adapter for VitalSim Test object Laerdal Control unit VitalSim and Power adapter for Vi- talSim FCC ID QHQ-FST1908 Report no. DANAK-196771 Project no. E500676-4 Test period 2003-01-27 to 2003-01-29, and 2003-02-26 Client Laerdal Medical Tanke Svilandsgt. 30, P.O. Box 377 4001 Stavanger Norway Telephone: 47 5151 1700 Fax: 47 5151 1788 Contact person Mr. Håkon Hodne Manufacturer Laerdal Medical Friwo Specifications 47 CFR Part 15, Subpart C - Intentional Radiators Results The equipment under test was in compliance with the requirements. Test personnel Henrik Nielsen Jesper Nielsen Date 2003-02-25 Responsible Vagn Sylvest Project Manager - EMC DELTA DANAK-196771 DELTA-E500676-4 Page 3 of 13 VS/AED Table of contents Page 1. Summaries 4 1.1 Technical report summary 4 1.2 Summary of tests 5 2. Test specimen 6 2.1 Test object - Control unit VitalSim 6 2.2 Test object - Control unit VitalSim 6 2.3 Test object - Power adapter for VitalSim 6 2.4 Test object - Power adapter for VitalSim (Rx) 7 2.5 AUX equipment – Megacode Manikin 7 3. General test conditions 8 3.1 Test set-up 8 4. Test and results 9 4.1 Conducted emission, AC mains (FCC Part 15, Subpart C) 9 4.2 Radiated electromagnetic field (FCC Part 15, Subpart C) 10 4.3 Occupied bandwidth 12 4.4 Peak output field strength 13 Annex 1 List of instruments (1 page) Annex 2 Photos (2 pages) Annex 3 Test record sheets regarding conducted emission (2 pages) Annex 4 Test record sheets regarding radiated emission (7 pages) Annex 5 Occupied bandwidth / Peak output power (2 pages) DANAK-196771 DELTA-E500676-4 Page 4 of 13 VS/AED 1. Summaries 1.1 Technical report summary The tests reported in this document have been performed to demonstrate compliance with the requirements of FCC Part 15, Section 15.249 "Rules for transmitters in band 902 - 928 MHz". Furthermore, during the tests it was verified that the receiver was in compliance with the requirements of FCC Part 15. This report contains measurement data from tests performed at DELTA, Hørsholm, Denmark, an FCC listed and DANAK accredited test laboratory. 1.1.1 Applicable FCC rules for test 47 CFR Part 15, Subpart C - Intentional Radiators §15.207 Conducted limits §15.209 Radiated emission limits, general requirements §15.215 Additional provisions to the general radiated emission limitations §15.249 Operation within the bands 902 - 928 MHz, 2400 - 2583.5 MHz. The methods and procedures have been applied as specified in: §15.31 Measurements standards. This points to the following procedure, used during the measurements in this report: ANSI C63.4:1992 Methods of Measurement of Radio-Noise Emissions from Low- Voltage Electrical and Electronic Equipment in the range of 9 kHz to 40 GHz. Furthermore, the requirements of the following have been applied: § 15.33 Frequency range of radiated measurements § 15.35 Measurement detector functions and bandwidths. DANAK-196771 DELTA-E500676-4 Page 5 of 13 VS/AED 1.2 Summary of tests The results of the emission tests can be summarised as follows: Tests of Intentional Radiator Key references to requirement FCC Part 15 Subpart C Conducted emission, AC mains § 15.207 Passed Radiated electromagnetic field emission §15.209 Passed Radiated emission limits, additional provisions §15.215 and §15.249 Passed Emission in restricted bands §15.205 Passed Abbreviations Passed : The requirements are met. Failed : The requirements are not met. Not done : No test was performed. N/A : Not applicable. Not relevant : The test was not relevant for the test object. The test results relate only to the objects tested. DANAK-196771 DELTA-E500676-4 Page 6 of 13 VS/AED 2. Test specimen The EUT is part of the Laerdal VitalSim system. It consists of a Control Unit connected to a manikin. The operation of the Control Unit can be controlled by the Laerdal Operat- ing Device. The system is used to train health care professionals and will be used only in professional training facilities. The test object can on the air interface receive and transmit data on one of five customer selected frequencies between 915.606 MHz and 916.484 MHz. The carrier is FSK modulated with 64 kHz swing at a bit rate of 9600 bps. During test two modules were used, one programmed to Rx-only (Unit-2) and the other to constant Tx or Rx, as appropriate. 2.1 Test object - Control unit VitalSim (Tx & Rx) Category SRD Manufacturer Laerdal Medical Model / type FST1908 Part no. - Serial no. Unit-1 FCC ID QHQ-FST1908 Supply voltage 9 VDC via 230 VAC adapter Operational mode TX 2.2 Test object - Control unit VitalSim (Rx) Category SRD Manufacturer Laerdal Medical Model / type FST1908 Part no. - Serial no. Unit-2 FCC ID QHQ-FST1908 Supply voltage 9 VDC via 230 VAC adapter Operational mode Rx 2.3 Test object - Power adapter for VitalSim (for Unit-1) Category IT Manufacturer Friwo Model / type FW75550/09 Part no. - Serial no. - FCC ID - Supply voltage 100-240 VAC 9VDC 1.5A Operational mode Normal operation DANAK-196771 DELTA-E500676-4 Page 7 of 13 VS/AED 2.4 Test object - Power adapter for VitalSim (for Unit-2) Category IT Manufacturer Mascot Model / type 9525 Part no. - Serial no. - FCC ID - Supply voltage 100-240 VAC 12VDC 0,8A Operational mode Normal operation 2.5 AUX equipment – Megacode Manikin Manufacturer Laerdal …

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DANAK-196771 DELTA-E500676-4A Page 1 of 3 VS/vs This exhibit is an amendment to Test Report exhibit for FCC ID QHQ-FST1908 Conducted emission, AC mains (FCC Part 15, Subpart C) The measurements have been performed on March 6, 2003, to comply with the require- ments for conducted emission in effect after July 10, 2005. Requirements Specification FCC Rules and Regulations Part 15, Subpart C Test set-up ANSI C63.4:1992 Frequency range 0.15-30 MHz Limit using quasi-peak detector 0.15-0.50 MHz *) 0.50-5.0 MHz 5.0-30 MHz 66-56 dBμV 56 dBμV 60 dBμV Limit using average detector 0.15-0.50 MHz *) 0.50-5.0 MHz 5.0-30 MHz 56-46 dBμV 46 dBμV 50 dBμV *) decreasing linear with the logarithm of frequency Results The module in Rx mode and in Tx mode is in compliance with the requirements. Comments None. DANAK-196771 DELTA-E500676-4A Page 2 of 3 VS/vs Test record sheet, conducted emission, 0.15-30 MHz DANAK-196771 DELTA-E500676-4A Page 3 of 3 VS/vs Test set-up Conducted emission, 0.15-30 MHz

DANAK-196771 DELTA-E500676-4 Annex 2 Photos (2 pages) This exhibit is an extract of DELTA Test Report E500676-4, DANAK 196771, containing only the photographs of representative test set-ups. DANAK-196771 DELTA-E500676-4 Photo 1 Set-up for measurements of conducted emission. Photo 2 Set-up for measurements 30 - 1000 MHz. DANAK-196771 DELTA-E500676-4 Photo 3 Set-up for measurements 1 - 10 GHz. One unit in Tx-mode and one in Rx-mode.

DANAK-196771 DELTA-E500676-4A Page 1 of 1 VS/vs This exhibit is an amendment to Test Setup Photos exhibit for FCC ID QHQ-FST1908 Conducted emission, AC mains (FCC Part 15, Subpart C) The measurements have been performed on March 6, 2003, to comply with the require- ments for conducted emission in effect after July 10, 2005. Test set-up. Conducted emission, 0.15-30 MHz