Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Prodigy Sleep System Operator Manual UNCONTROLLED COPY - SGS - 30-JAN-19
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Label Information and Manufacturer's Notes: Younes Medical Technologies (YMT) Unit 5 – 55 Henlow Bay Winnipeg, MB, Canada, R3Y 1G4 Canada 1-888-942-6774 Technical Support Our customer support staff can be reached through the following methods: Toll-free: 1-888-942-6774 Email: support@younesmedical.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Table of Contents WARNING, CAUTION, AND NOTE STATEMENTS...................................................................... 6 1. INTRODUCTION ............................................................................................................ 7 Intended Use .....................................................................................................................
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Sleep Study Configurations ............................................................................................................... 26 Full PSG Configuration Overview ................................................................................................................26 Level II ........................................................................................
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Appendix C Electromagnetic Compliance...................................................................................... 53 Appendix d Environmental Conditions .......................................................................................... 58 Appendix E Components with High Integrity Characteristics ........................................................
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 List of Tables Table 1 – Expected Service Life of Accessories ........................................................................................... 44 Table 2 - Equipment Classification .............................................................................................................. 50 Table 3 - Technical Specification of Prodigy Sleep System ......................
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Acronyms AAMI ANSI DC C CDC dB EEG FCC ft g Hz IEC IP LED lb m mm MSDS ORP Pa PC PPE Qty RSS USB V VAC VDC Vrms W YMT Association for the Advancement of Medical Instrumentation American National Standards Institute Direct Current Celsius Centers of Disease Control and Prevention Decibel Electroencephalogram Federal Communications Commission Feet Gram Hertz International Electrotechn
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Warning, Caution, and Note Statements Warning, Caution, and Note statements are used throughout this manual prior to operating or maintenance procedures, practices, or conditions considered essential to the protection of personnel or equipment and property. A Warning, Caution, or Note will apply each time the related step is repeated.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 1. Introduction This manual contains information to instruct the user how to use the various components of the system. Special skills and training are not required of the user, but it is imperative that all users have a full understanding of the entire system and the associated safety precautions before using the device.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 • Physical impairment resulting in inability to apply the home sleep testing equipment when another individual is not available to assist with this task. GENERAL SAFETY INFORMATION • • • • • • • • Magnetic and electrical fields are capable of interfering with the proper performance of the Prodigy Sleep System.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 • • children, pets and vermin and to make sure that these sources do not contaminate any components. Do not use components that appear to be physically damaged, degraded, or contaminated. Read and follow all instructions listed in this manual. WARNING No modifications of this equipment are allowed, as this could potentially result in an unsafe situation.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 all persons and must not be collocated or operating in conjunction with any other antenna or transmitter. INTENDED OPERATOR The intended operator of this device includes both technicians and users. 2. System Overview The Prodigy Sleep System is composed of three primary physical components: the Head Mounted Unit (HMU), Chest Mounted Unit (CMU) and the Table Top Unit (TTU).
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 PRODIGY SLEEP SYSTEM HMU The HMU is a small body worn device that is attached to the forehead via EEG electrodes during use. It has connectors to connect the EEG electrodes.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Figure 2 – Prodigy Sleep System HMU Rear View UNCONTROLLED COPY - SGS - 30-JAN-19 The HMU is powered by a rechargeable lithium polymer battery and the device is rated to operate continuously for at least 9 hours. To ensure adequate battery life, the batteries must be recharged after each sleep study is conducted.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 PRODIGY SLEEP SYSTEM CMU The CMU is a small body worn device that is attached to the chest via thoracic belt during use. It has connectors to connect the thoracic belt, abdominal belt and ECG/EMG electrodes.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 UNCONTROLLED COPY - SGS - 30-JAN-19 Figure 4 - Prodigy Sleep System CMU Rear View The CMU is powered by a rechargeable lithium polymer battery and the device is rated to operate continuously for at least 9 hours. To ensure adequate battery life, the batteries must be recharged after each sleep study is conducted.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 PRODIGY SLEEP SYSTEM TTU The Prodigy Sleep System TTU is a portable device that is equipped with a touch screen that is used for operation of the device. The TTU is powered by a 3000mAh non removable battery. To recharge the battery, the Charger/USB cable port is located at the bottom of the device. Insert the supplied charger and plug it into a power outlet.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Figure 6 – Prodigy Sleep System TTU Rear View Refer to the Technical Description in Section COPY 7 for additional information about the Prodigy Sleep UNCONTROLLED SGS 30-JAN-19 System TTU. WARNING Connect only items that have been specified in this manual as compatible. POWER SUPPLY CMU & HMU WARNING Use only the provided power supply.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 POWER SUPPLY TTU WARNING Use only the provided power supply. Use of unapproved or incompatible power supplies may result in equipment damage, electrical shock, or overheating which may result in personal injury or property damage. WARNING Keep away from children. Electrical shock can result if the power supply is put inside a person’s mouth.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 The Prodigy Sleep System is supplied with the following accessories: CMU ACCESSORIES HMU ACCESSORIES UNCONTROLLED COPY - SGS - 30-JAN-19 TTU ACCESSORIES USE ENVIRONMENT All components described in this manual are suitable for use in the user environment, including hospital, clinical, or home use environments. DUTY CYCLE The Prodigy Sleep System is rated for continuous operation.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 3. Instructions for Use USER TRAINING This Operator Manual provides a comprehensive description of the full capabilities of the Prodigy Sleep System. The Operator Manual comprises the primary training material for use of the Prodigy Sleep System.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 WARNING Use of accessories not described in this manual is potentially unsafe and is therefore not recommended. Use of unapproved accessories may result in increased emissions or decreased immunity of this equipment. WARNING Keep out of reach from children. Small parts such as the electrodes, plastic bags, and small components may be a choking or suffocation hazard.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 CAUTION Ensure the table surface area is level, clean and dry. Avoid placing objects that contain liquids such as glasses of water near the Prodigy Sleep System TTU to prevent possible spillage and equipment damage or electric shock. CAUTION Keep away from heat sources such as electric heaters, radiators, fireplaces, or other sources of heat.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Charging the HMU 1. To charge the HMU, connect the USB-C adaptor to the charging port on the HMU and plug the wall adapter into a power outlet. 2. Once the device is connected to the charger and plugged in, the LED light around the power button will immediately turn white, and remain white for several seconds and will output the charging status. a. Purple indicates charging b.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 WARNING Use only YMT approved chargers and cables. The use of unapproved chargers or cables may cause a battery charging delay or display a pop-up message regarding slow charging. It can also cause the battery to explode or damage the device. CAUTION The TTU has an internal rechargeable battery. For your safety, do not remove the embedded battery.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 ii. Level 2 iii. HMU Only d. HMU MAC Address e. CMU MAC Address (if applicable) f. Oximeter MAC Address (if applicable) 4. Press ‘Save Study Configuration’ 5. Press ‘Enter User Mode’ 6. Power off TTU Configure Sleep Study via Remote Server A technician can configure a sleep study via remote server. If the technician selects this method, follow the steps below: 1.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 2. 3. 4. 5. Press ‘Leave Kiosk Mode’ Press ‘Proceed’ when prompted to Enable USB Access Plug in USB and connect to computer Swipe down from top of screen a. Select Charging – Tap to change USB options b. Select ‘File Transfer’, ‘Just Once’ 6. Navigate to LG G PAD IV 8.0/Internal Storage/Prodigy/Folder labelled with Study ID 7. Copy sleep study data folder to your computer a.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 SLEEP STUDY CONFIGURATIONS The Prodigy Sleep System can be configured for different types of studies. Different configurations are required for different applications, and this section will present what each configuration looks like. The device is to be configured by the service provider prior to sending it home with a user.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Level II UNCONTROLLED COPY - SGS - 30-JAN-19 Figure 10 -Level II PSG Configuration 27 of 61
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 HMU Only Figure 11 - HMU Only PSG Configuration FREQUENTLY USED FUNCTIONS • • • • • • • • • • Plugging or removing the power supply from the wall outlet, as well as the back of the TTU. Plugging or removing the power supply from the wall outlet, as well as the bottom of the CMU. Plugging or removing the power supply from the wall outlet, as well as the back of the HMU.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 4.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Setup the Prodigy Sleep System in front of a mirror. It is recommended that you wear a thin t-shirt or pajama top along with loose pants/shorts. It should take approximately 30 minutes to apply the equipment. Important setup information: Application of the equipment will be in the following order: 1. Prodigy CMU 2. Prodigy HMU 3. Nasal Cannula 4.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Step 2: Apply the chest sensors. Below right collarbone Lower edge of left rib → Recommend your shirt be removed for this step. →Connect a single snap lead cable to each of the five single snap sensor pads while ignoring the colour of each cable.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Step 5: Connect the cables to the Prodigy CMU. → With your shirt on, connect the chest, legs, and effort belt cables to the CMU as shown below. → Push the connectors firmly into the CMU to ensure the connection is secure.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 SECTION 2: PRODIGY HMU SETUP Components needed: Prodigy HMU Dual Snap Sensor Pad (1x) Single Snap Sensor Pads (2x) Wired Sensor Pads (4x) Alcohol Swabs & Medical Tape Step 1: Connect the snap sensor pads to the Prodigy HMU. → Without removing the clear plastic backings, connect the dual snap sensor pad and two single snap sensor pads to the HMU.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 → If you have facial hair, alternative placement for sensor pad 3 is the soft tissue below the bony area behind the right ear. SECTION 3: NASAL CANNULA SETUP UNCONTROLLED COPY - SGS - 30-JAN-19 Components needed: Prodigy CMU Nasal Cannula (1x) Medical Tape Step 1: Connect the nasal cannula.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 → Screw the free end of the cannula onto the white fitting of the Prodigy CMU until snug as shown below. Be careful not to over tighten SECTION 4: PULSE OXIMETER SETUP Components needed: UNCONTROLLED COPY - SGS - 30-JAN-19 Step 1: Setup the pulse oximeter.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Step 1: Setup the TTU. → Plug the micro USB cord into the USB power adapter and connect to the TTU. → Plug the wall power adapter into an outlet making sure the TTU is within arm’s reach from the edge of your bed. → Turn on the Prodigy HMU and CMU by pressing the center power button and holding for five seconds (the blue light indicates the unit is on).
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 SPECIAL INSTRUCTIONS Power Failure During Study During some scenarios, the battery charge in the device may not be at an ideal level to remain functional throughout the entire study length. Ensure that the device is charged by using the provided power supply and power cable at least 1 hour prior to the commencement of the study.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 CAUTION Incorrect placement of the electrodes may result in loss of functionality or inaccurate data collected. Ensure electrodes are connected properly. Loose connections may cause incorrect or insufficient data to be collected.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 5. Re-Processing The Prodigy Sleep System is a reusable medical device that is intended to be re-processed by cleaning and disinfection between every use. Re-processing is to be done by authorized service personnel only in a designated cleaning area.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 CAUTION Wear personal protective equipment while reprocessing the device. Failure to wear personal protective equipment may result in contamination of the service personnel from the soiled components. PRE-CLEANING Promptly after use the HMU, CMU, TTU, and power supply shall be pre-cleaned. Pre-cleaning prevents soil from drying on the devices, which makes them easier to clean.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 WARNING Cleaning must be performed prior to disinfection. If a device is not cleaned soil can prevent the proper action of disinfection from occurring, as soil can protect microorganisms. Consequently, a soiled device can become a source for transmission of microorganisms. Wear protective disposable gloves and a mask during the cleaning procedure.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 WARNING Germicidal cloths may cause eye irritation and may be harmful if absorbed through the skin. Avoid contact with eyes or clothing. Wash thouroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco, or using the toilet.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 CAUTION Do not transport the device outside of the protective case, as this may result in damage to the equipment. Count the total number of each type of electrode and re-stock the case with the necessary replacements. Remember to check the expiry date on the electrode packaging before re-stocking the case with new electrodes. CAUTION Do not supply electrodes that are expired.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 EXPECTED SERVICE LIFE The HMU and CMU devices are powered by a rechargeable polymer lithium-ion battery with an 800mAh capacity. The battery will self-discharge over time, and if unused for an extended amount of time at low charge the battery could be irreparably damaged.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 6.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 • • • • o If device still does not connect power cycle TTU and all peripherals o If device still does not connect ensure device is assigned to TTU Oximeter displays Device Error on the TTU o Power cycle device o If device still does not connect power cycle TTU and all peripherals HMU signal(s) do not transition to 'Good' o Ensure all electrodes connected to HMU o Ensur
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 • • Device dies during the night o TTU will determine if sufficient data was collected prior to device dying o If insufficient data was collected a repeat study will be required TTU dies during the night o • • Insufficient data collected, a repeat study will be required TTU displays local validation pass but file fails to upload o Ensure TTU has internet connection and
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 7. Technical Description PRODIGY SLEEP SYSTEM HMU General Dimensions Weight Material Safety Power Interfaces Classification Operating Temperature 6-channel bio-potential signal capture and wireless transmission device 63x38x28 cm 56 g Medical Grade ABS-PC Protection Circuit Module (Battery Pack), Device Level Circuit Protection Operating: 3.7 VDC, Max. 800mAh Li/CoO2 Charging: 5.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Classification Operating Temperature N/A 0 °C to 40 °C UNCONTROLLED COPY - SGS - 30-JAN-19 49 of 61
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 8. Appendices APPENDIX A EQUIPMENT CLASSIFICATION The system belongs to protection class II with a BF applied part according to ANSI/AAMI ES606011:2005/(R)2012 with amendments.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 APPENDIX B TECHNICAL SPECIFICATION The system measures audio, EEG, EMG, respiratory effort, light and body position at the frequency range, bandwidth, and accuracy shown in Table 3 - Technical Specification of Prodigy Sleep System Additionally, a description of waveform displays (if applicable) and the functions performed by the Prodigy Sleep System to measure audio, EEG, EMG, respir
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Respiratory Effort (Belt) CMU N/A N/A Sampled, transmitted wirelessly, written to SD card None +/- 1% Resolution: N/A (Unitless Quantity) UNCONTROLLED COPY - SGS - 30-JAN-19 52 of 61
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 APPENDIX C ELECTROMAGNETIC COMPLIANCE The Prodigy Sleep System is intended for use in the electromagnetic environment specified below. The customer or the user of the Prodigy Sleep System should assure that it is used in such an environment. When the Prodigy Sleep System is exposed to electromagnetic (EM) disturbances, the system may show abnormal behaviour.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 3-2 Voltage Fluctuations/ Flicker Emissions IEC 61000-3-3 make it suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the EEG and ORP outputs on the Prodigy Sleep System are not used.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Voltage dips, short interruptions and volatage variations on power supply input lines IEC 61000-4-11 0 % UT (100 % dip in UT) for 0, 5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. N/A 70 % UT (30 dip in UT) for 25 cycles 0 % UT (100% dip in UT) for 5 sec Power frequency (50/60Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m typical commercial or hospital equipment.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 6 GHz 3 V/m 27V/m 385 MHz 28V/m 450 MHz 9 V/m 710/745/780 MHz 28 V/m 810/870/93O MHz 28 V/m 1720/1845/1970 MHz 28 V/m 2450 MHz 9 V/m 5240/5500/5785 MHz 𝑑𝑑 = 1.2√𝑃𝑃; from 80 MHz to 6 GHz 𝑑𝑑 = 2.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Table 6 - Recommended separation distances between portable and mobile RF communications equipment and the Prodigy Sleep System The Prodigy Sleep System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 APPENDIX D ENVIRONMENTAL CONDITIONS The environmental conditions for transport and storage, and during operation, are presented in Table 8 and Table 9 - Operating Conditions, respectively.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 APPENDIX E COMPONENTS WITH HIGH INTEGRITY CHARACTERISTICS When a component can generate an unacceptable risk due to a fault, such a component should have high integrity characteristics.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 APPENDIX G SYMBOLS USED ON PRODIGY SLEEP SYSTEM LABELING Table 10 - Regulatory Symbols Symbol Description and Usage Symbol for “SERIAL NUMBER” Used to identify the manufacturer’s serial number. Symbol for “REFERENCE NUMBER” Used to identify manufacturer’s reference number. Symbol for “MANUFACTURER” Used to identify the manufacturer’s name and address.
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 Table 11 - Electrical Symbols Symbol Description and Usage Symbol for “DIRECT CURRENT” Used to identify direct current. Symbol for “ALTERNATING CURRENT” Used to identify alternating current. Symbol for “ON” Used to identify when product is on (power). Symbol for “OFF” Used to identify when product is off (power).
Operator Manual – Prodigy Sleep System Revision: 04; CCRF-625 Effective Date: 30-Jan-19 Document Number: YST-UDoc-PR2-001-04 UNCONTROLLED COPY - SGS - 30-JAN-19 1 of 1
