Vios Medical CS2050 Vios Monitoring System (VMS) User Manual
Vios Medical Inc Vios Monitoring System (VMS)
User manual
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| Document ID | 3583932 |
| Application ID | Ny+csclxag0ArfhoLDWwEA== |
| Document Description | User manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 111.1kB (1388724 bits) |
| Date Submitted | 2017-09-28 00:00:00 |
| Date Available | 2018-01-03 00:00:00 |
| Creation Date | 2017-09-22 09:23:31 |
| Producing Software | Microsoft® Word 2010 |
| Document Lastmod | 2017-09-27 19:56:28 |
| Document Title | User manual |
| Document Creator | Microsoft® Word 2010 |
| Document Author: | Ben Meyer |
Chest Sensor Instructions For Use Model CS2050 FL00002046 Revision A Vios Medical, Inc. Vios Monitoring System 1 Introduction Revision History The cover page of this document has the revision letter at the bottom of the page. The revision letter identifies the document’s level of revision. The revision history of this document is summarized below. Revision Description Initial release. Package Contents One (1) Chest Sensor One (1) Chest Sensor Instructions For Use Vios Monitoring System Description The Vios Monitoring System includes: Chest Sensor: A plastic encased, Bluetooth-enabled reusable sensor. The Chest Sensor is used in conjunction with the Adapter and BSM to monitor heart rate, respiratory rate, pulse rate, SpO 2, and patient posture. Adapter: A plastic encased, reusable adapter with four (4) patient ECG cables and a one (1) pulse oximetry cable. The Adapter is used in conjunction with the Chest Sensor and BSM to monitor heart rate, respiratory rate, pulse rate, SpO2, and patient posture. The following Adapters may be used with the Chest Sensor: Model: L2050F Adapter (Finger Pulse Oximetry) Model: L2050E Adapter (Ear Pulse Oximetry) _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 2 of 28 Pulse Oximetry: Pulse Oximetry: Measurement Site: Finger Measurement Site: Ear Pulse Oximetry Cable Max Length: 36.75 inches Pulse Oximetry Cable Max Length: 22.5 inches ECG: ECG: 7-Lead 7-Lead RA Cables Max Length: 9.05 inches RA Cables Max Length: 9.05 inches LL Cable Max Length: 11.78 inches LL Cable Max Length: 11.78 inches V Cable Max Length: 14.78 inches V Cable Max Length: 14.78 inches Bedside Monitor (BSM) Software: Analyzes and displays vitals data from one or more compatible sensors. May operate in stand-alone mode or communicate analyzed data across standard networking protocols. Central Station Monitor (CSM) Software: Simultaneously displays analyzed data from the Bedside Monitor software for multiple patients. Central Station (CS) Software: A communication hub that transfers data between the BSM software and CSM software. Intended Use The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters. Intended Audience This manual is intended for clinical professionals. Clinical professionals are expected to have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients. Equipment Symbols Warning / Caution Do not use if package is damaged RoHS Compliant Date of Manufacture Manufacturer Type CF applied part symbol for shock protection _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 3 of 28 Non-ionizing radiation Not for general waste IP22 Ingress Protection. First 2 – Protection against fingers or similar objects > 12.5 mm. Second 2 – Protection against dripping water when tilted up to 15º Serial Number Bluetooth Low Energy MAC Address Consult Instructions for Use Not for use with MRI Rx Only For prescription use only Refer to Instruction Manual Electrostatic Sensitive Device Contraindications This device is contraindicated for use in the presence of Magnetic Resonance Imaging (MRI) devices. Warnings The Vios Chest Sensor and Adapter may cause interference with pacemakers/ICDs that utilize minuteventilation respiration detection The Vios Chest Sensor and Adapter to not detect pacing spikes generated from implanted pacemakers Remove the Vios Chest Sensor and Adapter from any patient prior to magnetic resonance imaging (MRI) Do not place the Vios Chest Sensor and Adapter on patients under the age of 18 Federal Law (US) restricts this device to sale by or on the order of physician _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 4 of 28 Do not apply the Vios Chest Sensor, Adapter, or electrodes on breached or compromised skin surfaces or on mucosal membranes Vios Medical recommends using Medico Electrodes MSGST-06 to adhere the Adapter and Chest Sensor to the patient No modification of this equipment internal or external is allowed Do not destroy this equipment without authorization of the manufacturer. Hazards can result from unauthorized modification of the equipment. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. Pins of connectors identified with the ESD warning symbol should not be should and that connections should not be made to these connectors unless ESD precautionary procedures are used. This equipment is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orientating or relocating the ME equipment or shielding the location. Use of adaptor, cables other than those specified, may result in increased emissions or decreased immunity. The CS2050 should not be worn and used adjacent to another wireless device such as mobile phone. Cautions The Vios Chest Sensor is a Bluetooth® low energy (BLE) device and should not be used in BLE sensitive areas The Vios Chest Sensor is a radio frequency (RF) emission device. Remove all components of the Vios Bedside Monitoring System in radio frequency sensitive areas. The VMS should not be used near direct X-ray exposure. The Vios Chest Sensor and Adapter must be removed from a patient prior to an upper torso X-ray The VMS should not be used near X-ray computed tomography (CT) equipment. The Vios Chest Sensor and Adapter must be removed from patient prior to a CT scan Never autoclave, sterilize, or immerse the Chest Sensor in liquid of any kind The following may degrade pulse oximeter performance: o Excessive ambient light o Excessive motion o Improperly applied sensor o Residue (e.g. dirt, dried blood) in the optical path o Blood pressure cuffs o Fingernail polish Notes: The following notice safety messages apply to this monitoring system. If VMS components have been transported or stored outside operating temperature, allow them to stabilize back to the operating temperature range before use. Portable and mobile RF communications equipment can affect the Chest Sensor and its communication with the VMS. Service and repairs are allowed for authorized Vios personnel only. The Chest Sensor is Internally Powered ME Equipment per IEC 60601-1 _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 5 of 28 FCC Compliance FCC compliance statements, 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, this including interference that may cause undesired operation. FCC Caution!!! • Any changes or modifications not expressly approved by the party Responsible for compliance could void the user's authority to operate this Equipment Part 15B compliance statements for digital devices: 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. —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 _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 6 of 28 2 Patient Application Caution: Examine the product package upon receipt and do not use components if there appears to be any damage. Contact Vios for a replacement product. See Vios Customer Service section. Notes: For instructions on how to use the Chest Sensor with the Vios Bedside Monitor Software (Model BSM2050), please refer to the Vios Bedside Monitor (Model BSM2050) Instructions For Use. Overview Component LED Indicator Patient Call Button Chest Sensor MAC ID (Last 4 Digits) 30-Pin Connector USB Connector Back Label Description Indicates various states of the Chest Sensor through red, yellow, green, and blue light with varying rates of blinking User actuation of this button drives various functionalities of the device (turning the device on/off, sending a distress signal to the BSM) Provides the last 4 digits of the Chest Sensor MAC ID for pairing to the BSM Connector to which the Adapter is attached Connector for charging the Chest Sensor battery Provides information pertaining to the MAC ID, serial number, manufacturing date, manufacturing lot, model number, and warning/cautionary symbols Patient Preparation Required Equipment: _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 7 of 28 Vios Chest Sensor, Model CS2050 Vios L2050F Adapter or L2050E Adapter Recommended electrodes Disinfecting wipes such as isopropyl alcohol or cleaning solution (not included) Warning: Perform visual inspection of the Chest Sensor, Adapter, and electrodes for any signs of damage prior to use. The components should not have any damage. If any damage is observed, then use a new set of components and contact Vios to replace damaged parts. Observe the chest and limb lead placement sites. Trim or clip hair if necessary. See Figure 1. Figure 1 Use disinfecting wipes to clean the Chest Sensor placement sites and limb lead placement sites. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 8 of 28 Figure 2 _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 9 of 28 Check Chest Sensor Battery Always check the Chest Sensor battery status prior to monitoring a patient. You may check the Chest Sensor battery status by pressing the Patient Call Button when the device is off. Do not press and hold. Briefly after pressing the Patient Call Button, the Chest Sensor LED will briefly display a color for 4 seconds. The displayed color will indicate the battery status – see the table below for the color representations: Use the battery status indication to guide your decision about whether that Chest Sensor has enough charge to be used for a certain period of time. If the Chest Sensor indicates low battery (red or blinking red), please consider _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 10 of 28 charging the Chest Sensor or using a different device. See the ‘Charging the Chest Sensor’ section for instructions on charging. Device Cleaning Use disinfecting wipes to clean the Chest Sensor and Adapter prior to patient application. The following may be used for cleaning the Chest Sensor and Adapter: Isopropyl Alcohol (70% Alcohol/water mixture) Hydrogen Peroxide Ethyl Alcohol (50% Alcohol/water mixture) Water Figure 3 Attach an Adapter Depending on where you want to monitor pulse oximetry, you may choose either a L2050F Adapter or L2050E Adapter. Slide the Chest Sensor into the Adapter so that the 30-Pin connectors mate. Ensure that the Chest Sensor is properly aligned on the Adapter rails. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 11 of 28 Figure 4 Caution: Ensure when sliding the Chest Sensor into the Adapter that the 30-Pin connectors are fully mated. Snap two (2) electrodes into the back of the Adapter. Ensure there is no overlap between the two electrodes. Caution: Ensure that when snapping the two (2) electrodes into the Adapter that there is no overlap between the electrodes. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 12 of 28 Snap four (4) electrodes into the RA, LL, and V lead snaps. Device Placement Peel off the adhesive liner from all six (6) electrodes. Attach the Chest Sensor with Adapter to the upper left pectoral area of the patient’s chest. Ensure that the device is positioned correctly per the image below. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 13 of 28 Affix the two Right Arm (RA) electrodes to the upper right pectoral area of the patient’s chest. Ensure the leads are positioned correctly per the image below. Affix the Left Leg (LL) electrode to the patient’s left abdominal area, below the Chest Sensor. Ensure the lead is positioned correctly per the image below. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 14 of 28 Lastly, affix the precordial (V) electrode to the patient. Placement of the electrode will determine which precordial lead is being monitored. The VMS may monitor one of the six (V1, V2, V3, V4, V5, V6) leads at a time – please see the image below for appropriate placement. Pulse Oximeter Placement Next, place the pulse oximeter at the appropriate site. The site will depend on which adapter was connected to the Chest Sensor – please refer to the corresponding section below: _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 15 of 28 L2050F Adapter Place the pulse oximeter finger clip over a finger on the patient’s left hand (index finger preferred). Ensure that the patient’s finger reaches the back of the pulse oximeter enclosure. It is recommended to tape down the cable slack to prevent accidentally pulling or yanking of the cable. See the picture below for recommended tape sites. L2050E Adapter Place the pulse oximeter ear clip over the patient’s earlobe. Ensure that the ear clip fully covers the earlobe and is secure. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 16 of 28 It is recommended to tape down the cable slack to prevent accidentally pulling or yanking of the cable. See the picture below for recommended tape sites. 3 Charging the Chest Sensor Overview The Chest Sensor uses a micro-USB connector for connecting to a charger. The charger must be connected to mains power to charge the Chest Sensor internal battery. Vios recommends using the following power supplies for charging the Chest Sensor: TRUMPower Medical Grade Power Supply, Model TRM15-S05-E-UB-10F ASUS Switching Power Supply, Model PSM06A-050Q Note: Please do not charge the Chest Sensor at temperatures less than or equal to 32°F. LED Indications When properly connected to a powered charger, the Chest Sensor LED will indicate a color based on the remaining battery life. See the images below for descriptions of each color representation. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 17 of 28 Use the battery status indication to guide your decision about whether that particular Chest Sensor should be used or not. If the Chest Sensor indicates low battery (red), please consider waiting for the Chest Sensor to fully charge or use a different, fully charged device. See the ‘Charging the Chest Sensor’ section for instructions on charging. Pairing to a Bedside Monitor Overview Before pairing the Chest Sensor with a Bedside Monitor (BSM), you must initiate Bluetooth Low Energy (BLE) advertising on the Chest Sensor. Initiating Bluetooth Low Energy (BLE) Advertising To initiate Bluetooth Low Energy (BLE) Advertising, press and hold the Patient Call Button for at least seconds (4) seconds. For the first four (4) seconds, you will see the battery status indicated as described in the ‘Battery Check’ section. If you continue to hold the Patient Call Button for more than four (4) seconds, the Chest Sensor LED will begin blinking blue at a rate of once per second. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 18 of 28 Pairing to a Bedside Monitor (BSM) Once you have initiated Bluetooth Low Energy advertising, pair the Chest Sensor to the Bedside Monitor (BSM) using the Bedside Monitor software. For instructions on how to do this, please refer to the Bedside Monitor (BSM2050) Instructions for Use. Confirmation of Pairing After pairing the Chest Sensor to the Bedside Monitor (BSM), the Chest Sensor LED will slowly blink green (once per 10 seconds) to indicate that it is paired. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 19 of 28 4 Troubleshooting Overview The troubleshooting section consists of several parts which should help you resolve the most common problems with the Chest Sensor. The ‘Common Issues’ section lists out the most likely issues you may encounter and the steps that should be taken to resolve them. Common Issues The Chest Sensor won’t fit into the Adapter. Ensure that the 30-Pin male connector on the Chest Sensor is properly aligned with the 30-Pin female connector on the Adapter. Ensure that the slots on the Chest Sensor are properly aligned with the rails on the Adapter. The Chest Sensor / Adapter does not adhere to the patient. Ensure that the steps in the ‘Patient Preparation’ section have been followed. Ensure that the Chest Sensor / Adapter have been placed per the ‘Device Placement’ section. The Chest Sensor will not turn on. Ensure that the steps in the ‘Check Chest Sensor Battery’ section have been followed. If the device is still not turning on, the battery may be depleted – try plugging it into a Vios recommended charger. Service & Maintenance If the device is damaged, please contact Vios for a replacement. Do not attempt to repair or service the device. See Customer Service information below. If you are suspicious of damage to the device, please inspect the following: Ensure there are no breaks or tears in any of the cables Ensure the snaps (both on the leads and on the back of the adapter) are not loose Ensure the 30-Pin connector is not loose To clean the Chest Sensor: Disconnect the Adapter from the Chest Sensor Dampen a clean cloth or gauze pad with appropriate cleaning solution and wipe all exposed surfaces including patient ECG cables and pulse oximetry cable/enclosure Dry all exposed surfaces with a clean, dry cloth or gauze pad For proper disposal, please return the device to Vios at the end of its service life. See Customer Service information below. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 20 of 28 5 Technical Specifications Materials and Dimensions Materials Dimensions High impact PC, ABS, or a ABS/PC blend 74.6mm X 62.0mm X 14.5mm Performance Specifications Minimum amplitude of QRS complex in the patient physiological signal Duration of use Use life Service Life Degree of protection Enclosure degree of Ingress protection 0.15 mV At least 28 hours on a new, fully-charged battery The Chest Sensor shall have up to 365 attach/detach events with the Adapter. The Chest Sensor shall have up to 365 attach/detach events with the Vios recommended charger. Expected to remain suitable for its intended use for up to 12 months Type CF applied part symbol for shock protection IP22 Caution: To prevent detection of P-waves or baseline noises as QRS complexes, the minimum detection level for QRS complexes as mentioned in the table above will be required for proper operation. Operating Environment Operating Temperature Storage and Transport Temperature Operating Humidity Storage and Transport Humidity Atmospheric Pressure Wireless Frequency and maximum radiated power Battery Specification Type Chemistry Capacity Voltage 10°C to 40°C -40°C to +70°C Relative humidity range from 10% to 95% (Noncondensing) Relative humidity range from 10% to 100% 80 kPa to 100 kPa f = 2402 + k*2 MHz, k = 0, … , 39 power: 0.01 mW (-20 dBm) … 10 mW (+10 dBm) Rechargeable Lithium-ion Polymer 1250 mAh (Typical), 1150 mAh (Minimum) 3.7 V (Nominal) _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 21 of 28 Dimension Safety Certification Battery Life 52.0mm X 34.5mm x 7.3mm IEC 62133:2012 28 hours of continuous use 6 Customer Service & Contact Information Vios Medical value’s our Customer’s feedback regarding our products, please call Vios Medical Inc. for any Customer Feedback, Complaints, or Return/Replacement Inquiries. Customer Service is available 24 hours a day, 7 days a week. Vios Medical USA: +1-651-764-8467 Vios Medical India: +91-(0)80-4115-0546 Vios Medical Marketing: +91-8427439000 support@viosmedical.com 7 Safety & Compliance Safety Notes The Vios Chest Sensor: Uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. May need special precautions regarding EMC and needs to be installed and put into service according to the EMC information. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 22 of 28 ECG signals must have a minimum QRS amplitude of 5uV. ECG signal amplitude lower than this will be inhibited by the system May be affected by portable and mobile RF communications equipment. Should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Vios Chest Sensor should be observed to verify normal operation in the configuration in which it will be used. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 23 of 28 Electromagnetic Emissions Table A: Guidance and manufacturer’s declaration – electromagnetic emissions – for all medical electrical equipment and medical electrical systems Guidance and manufacturer’s declaration – electromagnetic emissions The CS2050 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS2050 should assure that it is used in such an environment. Emissions test Compliance RF emissions Group 1 EN 55011 RF emissions Class B EN 55011 Harmonic emissions EN 61000-3-2 Voltage fluctuations / flicker emissions Class A Electromagnetic environment - guidance The CS2050 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The CS2050 is 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. Complies EN 61000-3-3 Table B: Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical electrical equipment and medical electrical systems Electromagnetic Immunity Guidance and manufacturer’s declaration – electromagnetic immunity The CS2050 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS2050 should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) Error! Reference source not found. 60601 test level Compliance level ± 6kV contact ± 6kV contact ± 8kV air ± 8kV air Electrical fast transient/burst ± 2 kV for power supply lines ± 2 kV for power supply lines EN 61000-4-4 ± 1 kV for input/output lines EN 61000-4-2 Electromagnetic environment – guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 24 of 28 Surge ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that of a typical commercial or hospital environment. < 5 % UT (> 95 % dip in UT) for 0,5 cycle < 5 % UT (> 95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles 70 % UT (30 % dip in UT) for 25 cycles Mains power quality should be that of a typical commercial or hospital environment. If the user of CS2050 requires continued operation during power mains interruptions, it is recommended that the CS2050 be powered from an uninterruptible power supply or a battery. < 5 % UT (> 95 % dip in UT) for 5 s < 5 % UT (> 95 % dip in UT) for 5 s 3 A/m 3 A/m EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11 Power frequency (50/60 Hz) magnetic field EN 61000-4-8 NOTE Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. UT is the a.c. mains voltage prior to application of the test level. Table C: Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical electrical equipment and medical electrical systems that are not life-supporting Guidance and manufacturer’s declaration – electromagnetic immunity The CS2050 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS2050 should assure that it is used in such an environment. Immunity test Error! Reference source not found. 60601 test level Compliance level Electromagnetic environment – guidance _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 25 of 28 Portable and mobile RF communications equipment should be used no closer to any part of the CS2050, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms EN 61000-4-6 150 kHz to 80 MHz 3 Vrms d [3,5 / V 1] P d [3,5 / E1] P d [7 / E1] P Radiated RF 3 V/m EN 61000-4-3 80 MHz to 2,5 GHz 3 V/m 80 MHz to 800 MHz 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CS2050 is used exceeds the applicable RF compliance level above, the CS2050 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the CS2050. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table D: Recommended separation distances between portable and mobile RF communications equipment and the medical electrical equipment and medical electrical systems – for medical electrical equipment and medical electrical systems that are not life-supporting Recommended separation distances between portable and mobile RF communications equipment and the CS2050 _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 26 of 28 The CS2050 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS2050 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CS2050 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d [3,5 / V 1] P d [3,5 / E1] P d [7 / E1] P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The Vios Monitoring System (VMS) has been designed in compliance with applicable Safety Standards given below. Safety Standards 60601-1: Safety Requirements for Medical Electrical Systems 60601-1-2: General Requirements for Safety – Electromagnetic Compatibility 60601-2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 60601-2-49: Particular requirements for the safety of Multifunction Patient Monitoring Equipment ISO 80601-2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 10993-1: Biological Evaluation of medical devices EN 300 328 v1.8.1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques ASTM D4169-14: Standard Practice for Performance Testing of Shipping Containers and Systems IEC 60529 standard Ingress Protection Marking – IP22 EC53 ECG Trunk Cables and Patient Leadwires Vios™ is a trademark of Vios Medical Incorporated. _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 27 of 28 ® Bluetooth is a registered trademark of Bluetooth SIG, Incorporated. Medico™ is a trademark of Medico Electrodes International Ltd. Manufactured by Vios Medical, Inc. 7300 Hudson BLVD N 140 St Paul MN 55128 +1 651-764-8467 _____________________________________________________________________________________________________________________________ Chest Sensor IFU Page 28 of 28
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