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MANL-B003-EN-V1.30 User Manual for Control Box BA6E-31/BA6E-32 Read the manual thoroughly prior to using the product About This Manual This manual is designed to assist you with the safe operation and recommended cleaning of the control box (BA6E-31/BA6E-32). Please read this manual carefully before operating or performing maintenance on this product. If you have any questions about how to use or clean the control box, contact your distributor before using the product. This manual contains instructions for use, troubleshooting and cleaning of the control box. Proper tutorials and trainings are required prior to the use of control box. Not all features described in this document may be available in all markets. Manufacturer reserves the right to modify, insert, and/or withdraw the information in this manual based on regulations/standards, product enhancements and market needs. Please contact your local distributor to get the latest information. Intended Use Control box (BA6E-31/BA6E-32) is designed for use as part of the Cognito 3.0 system. The Cognito 3.0 system is intended to provide bed exit and reposition notifications. It is indicated for use with patients in bed throughout the continuum of care. I Introduction The Cognito 3.0 system is designed for continuous and contact-free predictive patient monitoring. The system monitors patient movement/
mobility and can notify caregivers when a patient attempts to exit the bed or needs repositioning. Cognito 3.0 comprises of sensor pad, control box, Cognito cloud, Cognito dashboard and mobile app, providing bed exit and reposition related notifications for fall prevention and repositioning assistance for healthcare staff and professionals. The system also notifies patients with bedside alert from the control box when patients attempt to exit the bed. Bedside alert has multi-language options for different countries, and mute notification is also available while needed. The Cognito 3.0 is not a sterile medical device and must be cleaned between patients. When cleaning and disinfecting the product, always make sure to follow the standard sanitation procedure for repetitive use. Abbreviation Sensor Sensor pad II Symbols | Definition WARNING CAUTION Remind users of the potential hazards to prevent serious personal injury. Remind users of the potential hazards to prevent slight or medium personal injury, or equipment damage. On Product Type BF applied part IP22 IP22 Protected from touch by fingers greater than 12 millimeters Protected from water spray less than 15 degrees from vertical The CE Mark signifies the device has met the essential requirements of General Safety and Performance Requirements of European Medical Device Regulation (EU) 2017/745. The MD symbol indicates the item is a medical device. This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. III Refer to instruction manual This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation. FCC RF Radiation Exposure Statement:
This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator and your body. IV On Carton Fragile This way up Keep away from rain No cutting The stack limitation is 3 units The CE Mark signifies the device has met the essential requirements of General Safety and Performance Requirements of European Medical Device Regulation (EU) 2017/745. The MD symbol indicates the item is a medical device. Corrugated products for recycling V Table of Contents Ch.1 Exterior Introduction 1.1 Control Box (BA6E-31/BA6E-32) Ch.2 Operating Instruction 2.1 Installation Instructions 2.1.1 Use Wall Mount Plate with Glue Tape to Install 2.1.2 Use Wall Mount Plate with Screws to Install 2.1.3 Use VESA Mounts with Screws to Install 2.1.4 Remove the Control Box 2.2 Operating Instructions 2.2.1 Regular Settings 2.2.2 Nurse Mode 2.3 Acknowledging and Dismissing Notifications 2.3.1 Bed-Exit Related Notifications VI 1 1 5 5 6 8 12 16 18 18 21 23 24 2.3.2 Repositioning Related Notifications 2.3.3 Dismissing Leaving and Out of Bed Notifications 2.3.4 Dismissing Reposition Notifications Ch.3 Control Box Indicator Descriptions 3.1 Power Indicator Light Ch.4 Maintenance 4.1 Storage 4.2 Cleaning 4.3 Disinfection 4.4 Regular Maintenance 4.5 Disposal Ch.5 Troubleshooting Ch.6 Specifications Ch.7 EMC Description Information of Manufacturer and Contact VII 29 31 33 34 34 35 36 36 37 37 38 39 44 46 54 VIII Ch.1 Exterior Introduction 1.1 Control Box (BA6E-31/BA6E-32) 1. Control box (BA6E-31/BA6E-32) 4. Glue tape (ZDB0-A1) 2. Power adapter 5. Sensor cable part A (ZNA0-A1) 3. Wall mount plate (ZAC0-A1) 6. User manual 1 1. Power indicator/ Connection indicator 6. OK button 2. Screen 3. NFC sensing area 4. Return button 5. Selection buttons 7. Ethernet port 8. Sensor port 9. Power port 10. Speaker 2 1. VESA mount M3 screw holes 4. Serial number label 2. Hanger holes
(for wall mount plate) 3. SIM card cover 5. Control box label 6. Control box serial number 3 Note: Control box can be fixed on the wall with either wall mount plate or VESA mounts. Wall mount plate and glue tape are included in the standard package. VESA mounts are optional accessories. Contact the distributor or the manufacturer if VESA mounts set and screws were needed. 1. VESA wall mount 4. Wall mount screws 6#
2. VESA box mount 5. Box mount screws M3 3. Wall mount anchors 4 Ch.2 Operating Instruction WARNING 1. Operate the product under ambient temperature between 41F/5C to 104F/40C and relative humidity between 15% to 90%. 2. DO NOT modify the product. 3. If there is ever liquid on the surface of the device, dry the device immediately. 2.1 Installation Instructions WARNING 1. Confirm that there is no exterior damage on the product right after unpacking the product. 2. Immediately stop using the product if serious contamination or any damage is discovered. 3. Only use accessories, detachable parts, and materials that are approved by the manufacturer. 4. DO NOT use a damaged sensor cable. Contact the manufacturer or distributor if a damaged sensor cable is discovered. CAUTION 1. Disconnect the power adapter and the sensor cable before performing maintenance. 5 2.1.1 Use Wall Mount Plate with Glue Tape to Install 1 2 3 Attach the glue tape onto the wall mount plate in rounded square area. Stick and press the wall mount plate to the wall and let it sit for 24 hours. Align the hanger holes of the control box to the hanger buttons on the wall mount plate. While holding the control box with both hands, push the control box downwards until it clicks securely into the wall mount plate. 6 4 Plug in the sensor cable part A and the power adapter to the control box and the control box will automatically be turned on. NOTE: Wall mount plate can also be mounted on the wall with anchors and screws. Contact the distributor or the manufacturer for optional accessories. 7 2.1.2 Use Wall Mount Plate with Screws to Install WARNING 1. DO NOT install the device on wood studs, plaster boards or wall made with medium-density fiberboard (MDF). 2. DO NOT use your hands directly to install the control box with anchors and screws. Wear work gloves if necessary. CAUTION 1. Use the anchors and screws on concrete wall. 2. When drilling holes on the walls, make sure you use a drill and drill bit with the specified diameter. 3. Make sure to follow the instructions regarding to the depth of the holes. 4. If other types of anchors and screws were used, make sure the wall mount plate can be well-fixed. 8 1 2 3 P o s i t i o n a n d s k e t c h t h e location of wall mount anchors with wall mount plate. Drill two holes of 32 mm/1.26 inches depth using an 7mm drill bit where the anchor will be fixed. Clean out the drilled holes. 9 4 5 6 Use a hammer to insert the wall mount anchors into the holes. Place the wall mount plate and align it with the anchors. Use a screwdriver to lock and tighten the 6# screws in the anchors. 10 7 8 9 Align the hanger holes of the control box to the hanger buttons on the wall mount plate. While holding the control box with both hands, push the control box downwards until it clicks securely into the wall mount plate. Plug in the sensor cable part A and power adapter to the control box and the control box will automatically be turned on. 11 2.1.3 Use VESA Mounts with Screws to Install WARNING 1. DO NOT install the device on wood studs, plaster boards or wall made with medium-density fiberboard (MDF). 2. DO NOT use your hands directly to install the control box with anchors and screws. Wear work gloves if necessary. CAUTION 1. Use the anchors and screws on concrete wall. 2. When drilling holes on the walls, make sure you use a drill and drill bit with the specified diameter. 3. Make sure to follow the instructions regarding to the depth of the holes. 4. If other types of anchors and screws were used, make sure the VESA wall mount can be well-fixed. 12 1 2 3 Position and sketch the location of wall mount anchors with VESA wall mount. Drill two holes of 32 mm/1.26 inches depth using an 7 mm drill bit where the wall mount anchors will be fixed. Clean out the drilled holes. 13 4 5 6 Use a hammer to insert the wall mount anchors into the holes. Place the VESA wall mount and align it with the anchors like the image shown. Use a screwdriver to lock and tighten the 6# screws with anchors. 14 7 8 9 Assemble the control box and VESA box mount with the M3 screws. Hold the control box with both hands and slide the VESA box mount into VESA wall mount. Plug in the sensor cable part A and the power adapter to the control box and the control box will automatically be turned on. 15 2.1.4 Remove the Control Box To remove the control box, unplug the sensor cable part A from the gray plastic shell and the power adapter. Slide the control box upwards, parallel to the wall, from the wall mount plate or VESA wall mount. 16 WARNING 1. DO NOT pull the sensor cable with force. 2. DO NOT connect items that are not sensor cable part A to the sensor port. 3. DO NOT connect cables other than RJ45 type to the Ethernet port. 4. DO NOT put the Cognito product at the place which is difficult to cut off the power. CAUTION 1. Removing the control box in an incorrect way may cause damage to the wall mount plate or mounting surface. 2. Remove the power adapter from the control box if it will not be in use for a long time. 3. Recommend plugging the power adapter into the UPS
(Uninterruptible Power Supply). 4. Please place the sensor cable in an appropriate location so it will not affect the daily activity of patients or hospital staff. 5. Small parts, e.g. screws, should be kept out of reach of children under 3 years or any individuals who have a tendency to place inedible objects in their mouths. 17 2.2 Operating Instructions 2.2.1 Regular Settings Control box provides bed exit and reposition related notifications at the bedside. Bedside message from the control box is also provided to alert patients when patients are exiting the bed or have been out of bed. Default settings of control box are listed below. The settings can be adjusted from either control box or Cognito software. Please see Cognito 3.0 User Manual for using Cognito dashboard and mobile app. Items Volume Brightness Wandering Interval (minute) Reposition Interval (minute) Sitting Up Bedside Message Patient Language System Language Default Setting Off Dim 15 120 Off English English 18 1 2 3 Plug in the power adapter to the control box until the patient or system status is shown. It indicates the control box is ready for settings. Long press OK button to get into setting page. Select the setting items you would like to change. 19 4 Return to notification page to complete the change. 20 2.2.2 Nurse Mode Cognito notifications can be temporarily silenced for one minute with nurse mode while the patient is still on the bed to allow for regular nursing care and to avoid unnecessary notifications. Nurse mode is displayed with a blue + on the control box and is suggested to be activated while the patient is in bed and assistance is needed for helping patient getting out of the bed or for repositioning. 1 2 Press OK or Return button to get into nurse mode. To stop nurse mode, press OK or Return button once again. 21 3 O r y o u c a n w a i t f o r o n e minute, the control box will automatically return to regular use. 22 2.3 Acknowledging and Dismissing Notifications The control box provides bed exit and repositioning related notifications which can help with fall prevention and pressure injuries. Bed exit notifications include Stirring, Sitting Up, Leaving, Out of Bed and Wandering. Repositioning related notifications include Reposition and Immobile. Bed exit and repositioning related notifications are displayed on the control box in different colors. The control box also includes a bedside message designed to let the patient know that help is on the way when patients are exiting the bed or have been out of bed. Other notifications help to know the patients current status and the system error. Check Troubleshooting for error notifications. Notification Bed number Network connection 23 2.3.1 Bed-Exit Related Notifications Stirring This notification indicates the patient may be waking up from sleep based on patient activity. Waking up does not necessarily indicate a patient is at risk. However, it indicates that the patient is now more likely to attempt to exit the bed. The Stirring notification is displayed in green on the control box. 24 Sitting Up This notification indicates that the patient is sitting up from lying on the bed. When a patient is sitting up,it may indicate the patient intends to exit the bed, increasing their risk of an unassisted bed exit. The Sitting Up notification is displayed in yellow on the control box. Bedside message can be turned on for Sitting Up notification if it were necessary. 25 Leaving This notification indicates the patient may be attempting to leave the bed. It is also possible that the patient intends to sit at the edge of the bed; nevertheless, this could precede a fall and immediate assistance is recommended. The Leaving notification is displayed in red on the control box and triggers the bedside message. The bedside message can be dismissed by tapping OK or return button and get into the nurse mode, indicating someone is assisting the patient. 26 Out of Bed This visual notification indicates the patient has already exited the bed and will include a timer with the length of time the patient has been out of bed. The Out of Bed notification is displayed in red on the control box and alerts the patient with bedside message. The bedside message can be dismissed by tapping OK or return button and the screen will show Nurse Response, indicating someone has checked the situation. 27 Wandering During the set-up process with Cognito software, the clinician will determine if the patient is at risk of wandering. If they are, the healthcare staff should set up a wandering alert that will notify caregivers when the patient has exceeded the maximum amount of time the patient is allowed out of bed. When the wandering notification is selected, all other bed exit notifications will be automatically turned off. Wandering notification is displayed in red on the control box. The default time for triggering wandering notification is 15 minutes after the patient exits the bed. The time setting can be customized to individual patient needs. After the wandering notification is sent, a timer will start to let the healthcare staff and professionals know how much time has elapsed since the wandering notification was sent. 28 2.3.2 Repositioning Related Notifications Reposition When a patient is set-up for using Cognito product, the clinical team will determine how often they need to be repositioned. This can be based on individual patient need or facility protocol. The default time for repositioning notification is every two hours (120 minutes). After repositioning has been completed by either the clinical staff or if the patient has adequately repositioned themselves, the notification will automatically be dismissed. The Reposition notification is displayed in a lighter blue on the control box. 29 Immobile If the sensor pad does not detect patient movement for one hour, the system will send the Immobile notification so that the healthcare staff knows to check on them. The Immobile notification is displayed in a darker blue on the control box. 30 2.3.3 Dismissing Leaving and Out of Bed Notifications After a Leaving or Out of Bed notification is sent out, the healthcare staff will need to press the OK or Return button on the control box to dismiss the notification and to let others on the care team know they are assisting the patient. 31 Press OK or Return button 32 2.3.4 Dismissing Reposition Notifications The system notifies the healthcare staff and the professionals when patient stays on the bed with sustained unrelieved pressure for a pre-determined period of time. There are two ways a patient can be efficiently repositioned, either by a healthcare provider or by repositioning themselves. In both cases, when the patient is efficiently repositioned, the reposition notification will be dismissed and the repositioning timer will automatically reset. 33 Ch.3 Control Box Indicator Descriptions 3.1 Power Indicator Light Event Connected to the network Disconnected to the network Power Conncted Solid light No Power Conncted No light Blinking No light NOTE: If the power indicator is blinking green, please follow instructions in Cognito 3.0 System User Manual or contact the distributor or the manufacturer to build the network connection of control box. 34 Ch.4 Maintenance WARNING 1. Only use accessories, detachable parts, and materials that are approved by Cognito Health. 2. Only authorized professionals are permitted to disassemble the device. 3. DO NOT modify products. 4. DO NOT install or store products under direct sunlight or a dusty environment. CAUTION 1. To safely terminate operation of the system and perform maintenance, please disconnect the sensor cable and power adapter. 35 4.1 Storage After disconnecting the sensor cable, store the control box and the sensor pad under ambient temperature between -13F to 158F (-25C to +70C) and relative humidity condition between 15% to 90% RH. CAUTION 1. Be aware of the temperature and relative humidity of the storage environment. 4.2 Cleaning Please clean the products regularly. Weekly cleaning is recommended for the control box. 1. Wipe the control box with a clean, soft cloth. The cloth should be damped with 200ppm bleach. 2. Make sure there are no residues left on the control box. 3. Dry the control box completely before use. 4. Perform the disinfection procedures immediately upon patient discharge, bed transfer or body fluid contamination. See the disinfection procedures under 4.3. WARNING 1. DO NOT soak the device in cleaning solution or disinfectant. 2. If there is ever liquid on the surface of the device, dry the device immediately. 36 4.3 Disinfection Disinfecting the control box is suggested upon patient discharge, bed transfer or body fluid contamination. 1. Wipe the control box with a clean, soft cloth. The cloth should be damped with 500ppm bleach. 2. Make sure there are no residues left on the control box. 3. Dry the control box completely before use. WARNING DO NOT disinfect the control box by placing it in any UV light sterilization cabinets. CAUTION DO NOT disinfect the product with volatile liquids. 4.4 Regular Maintenance To prevent adverse events to the PATIENT and OPERATOR due to E L EC T RO M AG N E T I C D I ST U R BA N C ES , p l e a s e ta ke t h e fo l l o w i n g recommendations:
1. Maintenance before use is recommended for the control box. 2. DO NOT use a damaged sensor cable. Contact the manufacturer or distributor if a damaged sensor cable is discovered. 3. DO NOT use any other cables or accessories not approved by Cognito Health to avoid negative influence on electromagnetic compatibility. 4. Careful consideration and observation are essential when stacking or 37 collocating Cognito products and when routing cables and accessories. 5. Check if there is any damage to the power adapters power cord and plug head. 4.5 Disposal 1. The purchaser or user is responsible for rendering the device unusable if it is no longer to be applied (prevention of misuse). 2. The waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. 3. Please contact the distributor of the manufacturer for information concerning the decommissioning of your equipment. 38 Ch.5 Troubleshooting The control box provides several notifications if technical abnormalities were detected. Any other problem, please contact the distributor or the manufacturer for further assistance. Problem Troubleshooting Control box is unresponsive. Please refer to chapter 3; observe the power indicator and ensure that the power adapter is connected. Ensure the plug is plugged into the power outlet. Ensure the power adapter is plugged into the control box. 39 Please refer to chapter 3; observe the power indicator and ensure that the power adapter is connected. Make sure the sensor pad is connected and is not damaged. Patient left the bed, but the Out-of-Bed notification was not Please flatten the sensor pad and triggered. Control box has no sound. Control box has no light. remove any weight on top of the sensor pad. Lie on the sensor pad and get out of bed to check if Out of Bed notification is sent out. If out-of-bed notification were still not working, please contact the manufacturer or the distributor. Please ensure the control box is responsive. Follow 2.2 Operating Instructions to adjust the volume. Please ensure the control box is responsive. Follow 2.2 Operating Instructions to adjust the brightness. 40 Control box falls off from the hanger of the wall mount plate. Button on the control box in unresponsive. Follow 2.1 Installation Instructions to reinstall the control box. Please contact the manufacturer or the distributor if extra accessories were needed. Ensure the power adapter is plugged into the power outlet. Ensure the power adapter is plugged into the control box. If the button were still not working, please contact the manufacturer or the distributor. 41 Error Messages Possible Causes Solutions Sensor pad does not work right, or the sensor cable is damaged. Replace Sensor 1. Reconnect the sensor pad to the sensor port of the control box. 2. Reconnect the sensor cable part A and part B. 3. Replace the sensor pad. 4. If the problem is remaining, please contact the distributor or manufacturer for further assistance. NOTE: Sensor cable part B is in the package of the sensor pad (P7FD-21). 42 1.Reconnect the sensor cable to the sensor port of the control box. 2. Make sure the sensor cable cannot be loosened easily. 3. Replace the sensor pad. 4. If the problem is remaining, please contact the distributor or manufacturer for further assistance. 1. Control box may return to normal within 1 minute. If not, replug the power adapter to the control box. 2. If the error message is remaining, please contact distributor or manufacturer for further assistance. Sensor cable is not connected to the control box or not connected Sensor Disconnected tightly. Box Error Control box does not work right due to internal software abnormality. 43 Ch.6 Specifications Control Box (BA6E-31/BA6E-32) Dimension Weight Power Length Width Height Input Voltage BA6E-31 BA6E-32 5.12 inch (130 mm) 5.12 inch (130 mm) 1.38 inch (35 mm) 1 lb (450 g) 12V DC Adapter Model MDS-030AAC12 (DELTA) Adapter Input AC 100-240V, 0.6-0.4A, 50-60Hz Adapter Output DC 12V, 2A (Max) Interface Sensor Cable (ZNA0-A1) Mini DIN 7.87 inch (20 cm) to Cognito Dashboard Ethernet 10/100 Mbps IEEE 802.11 a/b/g/n/ac IP Code LTE for 4G SIM card*
IP22 SIM Card (4G) Supported*
Yes No Environment Atmospheric pressure 700 hPa to 1060 hPa Operating Temp. 41F to 104F (5C to 40C) Storage and Transportation Temp.
-13F to 158F (-25C to 70C) Operating Humidity Storage and Transportation Humidity Expected Service Life 15% to 90% RH 15% to 90% RH 5 Years 44 Accessories Model Name ZAC0-A1 Wall Mount Plate Glue Tape ZDB0-A1 Dimension Length 3.35 inch (85 mm) 3.78 inch (96 mm) Width 4.33 inch (110 mm) 3.31 inch (84 mm) Height 0.40 inch (10.25 mm) 0.04 inch (1 mm) Compatible Screw 6#
N/A VESA Wall Mount VESA Box Mount Model Name ZCB0-A1 Dimension Length 3.35 inch (85 mm) 4.33 inch (110 mm) Width 3.35 inch (85 mm) 4.33 inch (110 mm) Height 0.19 inch (4.7 mm) 0.26 inch (6.5 mm) Compatible Screw 6#
M3 45 Ch.7 EMC Description Manufacturers declaration - electromagnetic emissions The BA6E-31/ BA6E-32 is intended for use in the electromagnetic environment (for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) specified below. The customer or the user of the BA6E-31/ BA6E-32 should assure that it is used in such an environment. Electromagnetic environment-guidance
(for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) The BA6E-31/ BA6E-32 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 BA6E-31/ BA6E-32 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Emission test Compliance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Class B AC 120 V/60 Hz:
Not applicable AC 230 /50Hz:
Class A Voltage fluctuations AC 120 V/60 Hz:
Not applicable
/flicker emissions IEC 61000-3-3 AC 230 /50Hz:
Compliance 46 Manufacturers declaration-electromagnetic immunity The BA6E-31/ BA6E-32 is intended for use in the electromagnetic environment (for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) specified below. The customer or the user of the BA6E-31/ BA6E-32 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electrostatic discharge
(ESD) IEC 61000-4-2 Contact:8 kV Contact:8 kV Air2 kV,4 kV,8 kV,15 kV Air2 kV,4 kV,8 kV,15 kV Electrical fast transient/burst IEC 61000-4-4
+ 2kV for power supply lines
+ 1kV for input/
output lines
+ 2kV for power supply lines Not applicable Surge IEC 61000-4-5
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV,+ 2kV line(s) to earth
+ 0.5kV, +1kV,+ 2kV line(s) to earth Electromagnetic environment-guidance
(for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) 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 professional healthcare environment or HOME HEALTHCARE ENVIRONMENT. Mains power quality should be that of a typical professional healthcare environment or HOME HEALTHCARE ENVIRONMENT. 47 Voltage dips:
0 % UT; 0,5 cycle 0 % UT; 1 cycle|
70 % UT; 25/30 cycles Voltage interruptions:
0 % UT; 250/300 cycle Voltage dips:
0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/ 30 cycles Voltage interruptions:
0 % UT; 250/ 300 cycle 30 A/m 30 A/m 50 Hz or 60 Hz 50 Hz or 60 Hz Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50, 60 Hz) magnetic field IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. Mains power quality should be that of a typical professional healthcare environment or HOME HEALTHCARE ENVIRONMENT. If the user of the BA6E-
31/ BA6E-32 requires continued operation during power mains interruptions, it is recommended that the BA6E-31/ BA6E-32 be powered from an uninterruptible power supply or a battery. The BA6E-31/ BA6E-
32 power frequency magnetic fields should be at levels characteristic of a typical location in a typical professional healthcare environment or HOME HEALTHCARE ENVIRONMENT. 48 Manufacturers declaration-electromagnetic immunity The BA6E-31/ BA6E-32 is intended for use in the electromagnetic environment for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) specified below. The customer or the user of the BA6E-31/ BA6E-32 should assure that it is used in such and environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-
guidance
(for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) 49 Conducted RF IEC 61000-4-6 3 Vrms:
0,15 MHz 80 MHz 3 Vrms:
0,15 MHz 80 MHz 6 Vrms:
in ISM bands between 0,15 MHz and 80 MHz 6 Vrms:
in ISM bands between 0,15 MHz and 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the BA6E-31/ BA6E-
32 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:
80 % AM at 1 kHz 80 % AM at 1 kHz d = 1,2 d = 1,2 80MHz to 800 MHz d = 2,3 800MHz to 2,7 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). Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3 10 V/m 3 V/m 80 MHz 2,7 GHz 80 MHz 2,7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 50 Recommended separation distance between portable and mobile RF communications equipment and the BA6E-31/ BA6E-32 The BA6E-31/ BA6E-32 is intended for use in an electromagnetic environment (for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) in which radiated RF disturbances are controlled. The customer or the user of the BA6E-31/ BA6E-32 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BA6E-31/ BA6E-32 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d =1,2.... 80 MHz to 800 MHz d =1,2.... 800 MHz to 2,7 GHz d =2,3.... 0,01 0,1 1 10 100 0,12 0,38 1,2 3,8 12 0,12 0,38 1,2 3,8 12 0,23 0,73 2,3 7,3 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. NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 51 Manufacturers declaration-electromagnetic immunity Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment The BA6E-31/ BA6E-32 is intended for use in the electromagnetic environment (for the professional healthcare facility environment and HOME HEALTHCARE ENVIRONMENT) specified below. The customer or the user of the BA6E-31/ BA6E-32 should assure that it is used in such an environment. Compliance LEVEL
(V/m)
(for professional healthcare and HOME HEALTHCARE ENVIRONMENT) 27 28 9 Test frequency
(MHz) Band a)
(MHz) Service a) Modulation b) Maximum power
(W) Distance
(m) IMMUNITY TEST LEVEL
(V/m) 385 380 390 TETRA 400 450 430 470 GMRS 460, FRS 460 Pulse modulation b) 18 Hz FM c) 1,8 0,3 5 kHz deviation 2 0,3 1 kHz sine 27 28 704 787 LTE Band 13, Pulse modulation b) 17 217 Hz 0,2 0,3 9 710 745 780 810 930 1 720 1 845 1 970 870 800 960 GSM 800/900, TETRA 800, Pulse modulation b) 18 Hz iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
2 0,3 28 28 1 700 1 990 GSM 1900;
Pulse modulation b) DECT; LTE 217 Hz Band 1, 3, 4, 25; UMTS 2 0,3 28 28 52 2 400 2 450 2 570 Bluetooth, WLAN, 802.11 b/
g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0,3 28 28 5 240 5 500 5 785 5 100 5 800 WLAN Pulse modulation b) 802.11 a/n 217 Hz 0,2 0,3 9 9 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 53 Information of Manufacturer and Contact Please note that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Manufacturer / Asia Contact Cognito Health Inc. (former MedicusTek Inc.)
+886-2-2655-8672 No. 3 Yuanqu St., 9F.-1, Nangang Dist, Taipei 11503, Taiwan www.cognitohealth.com US Local Contact Cognito Health Corporation (former MedicusTek USA Corp.)
+1-623-224-6400 1300 S. Litchfield Road Suite 110-G Goodyear, Arizona 85338 USA info@cognitohealth.com 54 UK Responsible Person Medstrom Healthcare Ltd.
+44-845-371-1717 Unit 2 Cygnus Court Beverley Road, East Midlands Airport, Castle Donington, Derby, Derbyshire, DE74 2SA United Kingdom EU Authorised Representative Joerns Healthcare B.V.
+31-88-208-0200 Zeilschip 26 3991 CT HOUTEN Nederland 55 Distributor 56 THE WARRANTY IS VOID IF THE PRODUCT HAS BEEN OPENED, SUBMERGED, OR MISUSED (E.G., USED CONTRARY TO THE INSTRUCTIONS OR TO THE INTENDED USES OF THE PRODUCTS). THE COMPONENTS OF THE PRODUCTS ARE SUBJECT TO THE LIMITED WARRANTY PERIOD(S) AS SET FORTH IN THE PRODUCT AGREEMENT BETWEEN MANUFACTURER AND PARTNER. COPYRIGHT 2022 BY COGNITO HEALTH INC. ALL RIGHTS RESERVED. NO PART OF THIS PUBLICATION MAY BE REPRODUCED, DISTRIBUTED, OR TRANSMITTED IN ANY FORM OR BY ANY MEANS, INCLUDING PHOTOCOPYING, RECORDING, OR OTHER ELECTRONIC OR MECHANICAL METHODS, WITHOUT THE PRIOR WRITTEN PERMISSION OF THE PUBLISHER, EXCEPT IN THE CASE OF BRIEF QUOTATIONS EMBODIED IN CRITICAL REVIEWS AND CERTAIN OTHER NONCOMMERCIAL USES PERMITTED BY COPYRIGHT LAW. FOR PERMISSION REQUESTS, WRITE TO THE PUBLISHER, ADDRESSED ATTENTION: PERMISSIONS COORDINATOR, AT THE ADDRESS SHOWN IN THIS PUBLICATION. MANL-B003-EN-V1.30 Apr., 2022
1 | ID Label/Location Info | ID Label/Location Info | 151.30 KiB | April 26 2022 |
Cognito Health Inc. www.cognitohealth.com BA6E-32 Control Box S/N :1B0001 P/N :0100405 MFD: 2022-09-24 Contains FCC ID: TX2-RTL8822CE FCC ID: 2ASHF-BA6EN Adapter: MDS-030AAC12(DELTA) Input: AC 100-240V, 0.6-0.4A, 50-60Hz2 Output: DC 12V, 2A (Max) 1B0001 Made in Taiwan Cognito Health Inc. www.cognitohealth.com BAG6E-31 Control Box S/N :1A0001 P/N :0100400 MFD: 2022-09-24 Contains FCC IDs: TX2-RTL8822CE, 2AJYU-8PYA007 FCC ID: 2ASHF-BA6EN Adapter: MDS-030AAC12(DELTA) Input: AC 100-240V, 0.6-0.4A, 50-60Hz2 Output: DC 12V, 2A (Max) 1A0001 Made in Taiwan
1 | Declaration of authorization | Cover Letter(s) | 118.80 KiB | April 26 2022 |
CoG NiTO RF_160, Issue 04 HEALTH Declaration of Authorization We Name: <Cognito Health Inc.>
Address: 9F. -1, No.3 Yuanqu St. Nangang Dist. Taipei City City: Taipei City Country: Taiwan Declare that:
Name Representative of agent: Jim Chang Agent Company name: SGS Taiwan Ltd. Address: 134, Wu Kung Road, Wu ku Industrial Zone TW- New Taipei City 24803 City: New Taipei City Country: Taiwan is authorized to apply for Certification of the following product(s):
Product description: Control Box Type designation: BA6E-31/ BA6E-32 Trademark: Cognito Health Validity/ expiry date:
on our behalf, including signing of all documents relating to these matters. Date: March 29, 2022 City: Taipei City Name: Kylie Chang Function: Regulatory Affairs Specialist Signature: Ayo Chg
1 | Test Setup Photos Part 1 | Test Setup Photos | 3.59 MiB | April 26 2022 / October 24 2022 | delayed release |
1 | Test Setup Photos Part 2 | Test Setup Photos | 3.35 MiB | April 26 2022 / October 24 2022 | delayed release |
1 | confidentiality | Cover Letter(s) | 195.59 KiB | April 26 2022 |
FCC, Request for non-disclosure Date: 16-Jul-10 RF_501, Issue 6 Page 1 of 1 Company Name: Cognito Health Inc. Address: 9F.-1, No.3 Yuanqu St. Nangang Dist. Taipei City City: Taipei City Country: Taiwan To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: 2ASHF-BA6EN Reference number: #HHHH Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application:
C1 Bill(s) of Material &] Block Diagrams X] Operational Description [X] Schematic Diagrams (0 Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (note 1):
X] Internal Photos User's Manual &X] Test Set-up Photos External Photos Planned Release Date STC: 180 days (notes 2, 3, 4, 5) Date:29/03/2022 Name and signature of applicant: Kylie Chang las ions Notes:
1) A document or type of document can only have ONE type of confidentiality!
2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)!
3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this!
5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-04-26 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-04-26
|
||||
1 | Applicant's complete, legal business name |
Cognito Health Inc.
|
||||
1 | FCC Registration Number (FRN) |
0032060519
|
||||
1 | Physical Address |
9F.-1, No.3 Yuanqu St. Nangang Dist. Taipei City
|
||||
1 |
115
|
|||||
1 |
Taipei, N/A
|
|||||
1 |
Taiwan
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@telefication.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2A5HF
|
||||
1 | Equipment Product Code |
BA6EN
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K******** C******
|
||||
1 | Telephone Number |
886-2********
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
k******@cognitohealth.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS Taiwan Ltd
|
||||
1 | Name |
J****** C****
|
||||
1 | Physical Address |
134, Wu Kung Road, WuKu Industrial Zone
|
||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
+8862********
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
j******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
SGS Taiwan Ltd
|
||||
1 | Name |
J**** C******
|
||||
1 | Physical Address |
134, Wu Kung Road, WuKu Industrial Zone
|
||||
1 |
Taiwan
|
|||||
1 | Telephone Number |
+8862********
|
||||
1 | Fax Number |
886-2********
|
||||
1 |
j******@sgs.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/24/2022 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Control Box | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS Taiwan Ltd. Central RF Lab
|
||||
1 | Name |
R**** W******
|
||||
1 | Telephone Number |
+886-******** Extension:
|
||||
1 |
r******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC