FCC ID: 2A277TOLOGG33 B Medical System

TOLOGG-3.3-GL User Manual Revision 3.6 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 2 Contents Overview ............................................................................................................................................................. 3 1. Presentation .................................................................................................................................................. 4 1.1. Logger ..................................................................................................................................................... 4 1.2. Accessories ............................................................................................................................................ 5 1.3. Power supply cable ............................................................................................................................ 6 1.4. Temperature sensors ........................................................................................................................ 6 1.5. Door sensor ........................................................................................................................................... 9 1.6. SIM card holder ................................................................................................................................ 11 1.7. Mounting holder .............................................................................................................................. 12 1.8. Dust cover ........................................................................................................................................... 14 2. Getting started .......................................................................................................................................... 15 2.1. Turning on the logger .................................................................................................................... 15 2.2. Turning off the logger .................................................................................................................... 15 2.3. Led indications ................................................................................................................................. 15 2.4. Diagnostic mode .............................................................................................................................. 16 3. Technical characteristic ......................................................................................................................... 18 3.1. Power supply ..................................................................................................................................... 18 3.2. RF characteristics ............................................................................................................................ 18 3.3. Mechanical characteristics ........................................................................................................... 19 3.4. Environment ...................................................................................................................................... 19 3.5. Temperature sensors characteristics...................................................................................... 19 4. Product identification label ................................................................................................................. 20 5. Transport restrictions ............................................................................................................................ 21 6. B Medical Temperature Monitoring System .................................................................................. 22 7. Troubleshooting ....................................................................................................................................... 23 8. Certification................................................................................................................................................ 24 9. Safety recommendations ...................................................................................................................... 25 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 3 Overview TOLOGG-3.3-GL is a configurable electronic logger for monitoring storage condition in vaccine refrigerators. It is a small GSM/UMTS and GPS logger with two temperature sensors (internal and external) and a door sensor. It measures and transmits the collected data online to a web server called Temperature Monitoring System. With TOLOGG-3.3-GL the user can monitor their refrigerators or freezers and increase the efficiency of storage management. Main features:

two temperature sensors one open door sensor minimum 7 day operation of the battery 60 days of data storage wide power supply range 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 4 1. Presentation 1.1. Logger Logger connectors are shown in Figure 1 and described below. Button ON/Standby The color of the markers corresponds to the color of the cables. A B C D Figure 1 Connectors description A Internal temperature sensor connector B External temperature sensor connector C Door sensor connector D Power supply connector The button is used to turn on a device and switch to standby mode In mode standby the device is charging the battery, the charge status is indicated by the PWR LED (see chapter 2.3. Led indications). It is possible to switch from standby mode to on mode remotely using the service application. There are four markers on the bottom of each logger panel which help to connect the appropriate cable:

Blue internal temperature sensor 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 5 White external temperature sensor Gray door sensor Black power cable NOTE: At the end of logger installation, dust covers should be applied to unused connectors, see paragraph 1.8. Dust cover 1.2. Accessories 1A 1B 1C 3 4 5 7 Figure 2. Logger accessories The accessories include:

1. Power cable, two possible variants of termination and cable with fuse 2. External temperature sensor 3. Internal temperature sensor 4. Internal temperature sensor up to -80C 5. Door open sensor 2 6 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 6 6. Dust cover 7. Mounting holder 1.3. Power supply cable The power supply cable needs to be screwed to the logger connector (black marker). Connect the power supply cable to the internal power supply of the monitored refrigerator. Figure 3. Power supply cables Figure 4. Power supply cable with fuse 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 7 1.4. Temperature sensors The figures below present two temperature sensors. The blue sensor is intended to measure the temperature inside cooling devices. The white sensor measures the temperature outside cooling devices. Figure 5. Internal temperature sensor Figure 6. Internal temperature sensor up to -80C 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 8 Figure 7. External temperature sensor The external sensor needs to be fixed to the holder as described in paragraph 1.7. Mounting holder. The inner sensor needs to be installed into the cooling device as specified by the refrigerator manufacturer. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 9 1.5. Door sensor The door sensor consist of two parts. Sensor (Figure 8 part 2) needs to be fixed to the holder as described in paragraph 1.7. Mounting holder. Magnet (Figure 8 part 1) must be screwed to the refrigerator door. 1 2 Figure 8. Door sensor 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 10 The correct and incorrect positions of the magnet are shown below. When the door is closed, the gap between the magnet and the sensor should not be greater than 3 mm. Figure 9. Correct installation of door sensor. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 11 1.6. SIM card holder Logger has an external SIM holder located at the back of device. To insert the SIM card, unscrew the both screws as shown in the Figure 10. Make sure that the cover seal is properly placed as shown in the Figure 11. Insert the SIM card as shown in the Figure 12, place the cover back on the back of the logger and fix it by using both screws. Figure 10. SIM holder Figure 11. Opened SIM holder correct position of the seal 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 12 Figure 12. Opened SIM holder correct position of the SIM card 1.7. Mounting holder The mounting holder (Figure 13) is used to hold the logger outside the cooling device. The holder should be screwed to the wall of the monitored object, and then slide the recorder into the holder. Installation of the handle and the door sensor should be made with tools and screws, adapted to the appropriate material from which the surface to which the handle and the door sensor are mounted. The holder contains a fixing mechanism for the door sensor and temperature sensor. Figure 14 shows how to fix a temperature sensor, Figure 15 shows how to fix a door sensor. Figure 13. Mounting holder 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 13 Figure 14. Fixing an outside temperature sensor. Figure 15. Fixing a door sensor. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 14 1.8. Dust cover Any unused connectors should be protected by dust covers as shown in Figure 16. Figure 16. Dust covers installation. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 15

2. Getting started 2.1. Turning on the logger To turn on the logger, please press and hold the button until MEAS and ACT LEDs will both light up, then release the on/off button. After that the LED ACT will flash quickly, until the initial procedure ends. For GPS location, the first activation has to be done outside the building. Please turn on the logger and leave it outside for at least 20 minutes. 2.2. Turning off the logger To turn off the logger, please press and hold the button until MEAS and ACT LEDs will both light up, then release the on/off button. After that the LED ACT will flash quickly and the MEAS will stay on, until all measurements are sent to the server. 2.3. Led indications The logger has LED indicators as described in Table 1 and Table 2. Table 1. LED descriptions Name ACT ERR PWR MEAS Color Green Red Yellow Green Description Indicates logger activity Indicates the alarm temperature level in the fridge Indicates the connection of an external power source Indicates the correct temperature level in the fridge Table 2. LEDs indications descriptions LEDs ERR

PWR

MEAS

Normal operation. Description ACT Flashes every 3 sec Flashes every 0.5 sec

Flashes every 1 sec Flashes two times every 1 second

On Off Flashes every 3 sec Off

Communication with the server. Internal temperature sensor is in normal range Internal temperature sensor is not connected Alarm state due to internal sensor temperature below the normal range Alarm state due to internal sensor temperature above the normal range External power is connected. External power is disconnected. 820.9506.89

TOLOGG-3.3-GL User Manual Revision: 3.6 Page 16 Flashes 1 time every 3 seconds Flashes two times every 3 seconds Flashes one time every 1 second

Battery level > 50%

Battery level < 50%

Alarm state due to low battery level 2.4. Diagnostic mode In diagnostic mode it is possible to check a status of:

GPS position battery charge connection to server To enter into diagnostic mode, please press the button 5 times within 3 seconds. The LEDs will show the diagnostic status as follow:

ACT LED will light green if the logger has found a valid GPS position. ERR LED will light red if the logger has not found a valid GPS position yet. Table 3. ACT and ERR LEDs description during diagnostic mode LED ACT ERR Behavior Light green Light red Description Logger received the correct GPS position Logger not found a GPS position yet MEAS LED will be flashing as described in a table below. Table 4. Description of the MEAS LED indication MEAS LED behavior No flash Description Diagnostic information not available. 1 flash No connection. 2 flashes Lights up for 4 seconds Successful sent of data. Data sent by SMS. Possible reason There is no valid connection yet. Functionality is available from firmware version 2.4.2017092001. SIM not inserted. SIM card with PIN. Fail during read of SIM. No GSM coverage. SIM chip deactivated. No credit. Weak GSM coverage. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 17 PWR LED will be flashing as described in a table below. Table 5. Description of the PWR LED indication PWR LED behavior Description 1 flash 2 flashes 3 flashes 4 flashes Battery discharged Battery needs to be charged Sufficient battery charge Battery fully charged Range

< 20%

20% - 50%

50 % - 100%

100%

820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 18 3. Technical characteristic 3.1. Power supply The power characteristics are shown in the following table:

Table 6. Power supply Parameter Value Power supply range 5 to 47 V DC Max. power Max. current consumption 2.5 W 400 mA Internal battery Lithium polymer Capacity: 980 mAh Logger without external power supply will operate on battery power for at least 7 days. Logger is charging the internal battery at temperatures from 0 to 43C. 3.2. RF characteristics TOLOGG-3.3-GL supports the frequencies described in a table below. Please make sure that the logger can be used in your country and for your network provider. Table 7. Operating frequencies Network technology Operating frequencies UMTS GSM 800/850/900/1900/2100 MHz 850/900/1800/1900 MHz 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 19 Environmental characteristics of the TOLOGG-3.3-GL logger are shown in the table below:

3.3. Mechanical characteristics Mechanical characteristics are shown in the table below:

Table 8. Mechanical characteristics Parameter Description Max. dimensions 68 x 95 x 25 mm (without connectors) Weight IP rating 105 g IP65 3.4. Environment Table 9. Environmental requirements Parameter Minimum Maximum Operating temperature range

-30C 60C Storage temperature

-40C

+85C Humidity 0%

95%

3.5. Temperature sensors characteristics Table 10. Temperature sensor characteristics Parameter Value Measuring range

-30 to +60C Accuracy Resolution 0.4 C 0.1 C Characteristics of both the temperature sensors are shown in the below table:

820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 20 4. Product identification label Product identification labels are on the logger and on the box of the product. They include the following information:

manufacturer name and address QR code WEEE directive symbol (crossed out wheelie bin) the CE marking FCC ID Serial number (IMEI) Product number Logger model Input voltage range and power consumption Figure 17. Logger label 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 21 5. Transport restrictions 1. During transport by air, loggers must be turn off. 2. There is no additional restriction, if you want to transport by air no more than two loggers in one package. follow:

3. If you want to transport by air more than two loggers in one package, you have to

- maximal number of loggers in one package cannot be bigger than 250

- package has to be labeled with sign: UN3481 4. Logger contains Lithium-polymer accumulator. Therefore please contact your courier company for additional requirements. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 22 6. B Medical Temperature Monitoring System The Temperature Monitoring System is described in a separate document B Medical Temperature Monitoring System manual. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 23 7. Troubleshooting 1. No data in the Temperature Monitoring System or no SMS received:

Logger battery is too low please connect the power cable and the external power supply to the cable The Logger is turned OFF please press and hold the button to turn on the logger. GSM/UMTS signal out of range move the logger to an area with sufficient GSM/UMTS signal strength. 2. No logger position on the map in the Temperature Monitoring System:

No GPS signal reception move logger to an area with sufficient GPS signal (outside the building), turn it OFF and turn it ON again. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 24 8. Certification FCC Information This device complies with Part 15 of the FCC Results. Operation is subject to the following two conditions:

(1) This Device may not cause harmful interface, and

(2)This Device must accept any interference received, including interference that may cause undesired operation. Note : This equipment has been tested and found to comply with the limits for CLASS B digital device, pursuant to Part 15 FCC Rules. These limits are designed to provide reason-

able protection against harmful interference when the equipment is operated in a com-

mercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harm-

ful 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 correct the interference by one or more of the following measures:

1.1. Reorient or relocate the receiving antenna. 1.2. Increase the separation between the equipment and receiver. 1.3. Connect the equipment into an outlet on a circuit different from that to which receiver is connected. 1.4. Consult the dealer or experienced radio/TV technician for help. WARNING Changes or modifications not expressly approved by the manufacturer could void the users authority to operate the equipment. 820.9506.89 TOLOGG-3.3-GL User Manual Revision: 3.6 Page 25 9. Safety recommendations READ CAREFULLY 1. Be sure the use of this product is allowed in your country and that you have appro-

priate environmental conditions. The use of this product may be dangerous and has to be avoided in the following areas:

where it can interfere with other electronic devices in environments such as, aircrafts, etc. where there is a risk of explosion such as petrol stations, oil refineries, etc. 2. It is the responsibility of the user to enforce the countrys regulation and the spe-

cific environmental regulations. 3. Do not disassemble the product. Any sign of tampering will compromise the valid-

ity of the warranty. product. 4. Follow the instructions of the hardware user guides for the correct wiring of the 5. The product has to be supplied with a stable voltage source and the wiring has to conform to the security and fire prevention regulations. 6. The system integrator is responsible for the functioning of the final product. Should there be any doubt, please refer to the technical documentation and the regulations in force. 7. Do not dispose of the logger in a fire, as it may cause an explosion. 8. Installation should be made with tools and screws, suitable to the material, to which they will be fixed. 9. RF EXPOSURE WARNING: When the logger is on, keep the distance of 20cm between the device and the body. 820.9506.89

Made by Elproma Elektronika Sp. z 0.0. ul. Duriska 2A =

05-152 Czosn6w POLAND Oo}

for B Medical Systems FCC ID: 2A277TOLOGG33 Contains FCCID: XMR201508UG96 IMEI: 867688038672576 296.9777.70 Model: TOLOGG-3.3-GL Input voltage: === 5- 47V max 0,4A ne

, CT ut nO 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1 10 11 12 13 14 15

Elproma Elektronika Sp. z o.o. Duska 2A 05-152 Czosnw Request for Confidentiality Date: 20.09.2021 Subject: Confidentiality Request regarding application for certification of FCC ID: 2A277TOLOGG33 Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:

Exhibit Type Block diagrams Internal photos Operation description Parts list/BOM Schematics User manual Layout Type of Confidentiality Requested Permanent Short-term Permanent Permanent Permanent Short-term Permanent The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

Pursuant to DA04-1705 June 15, 2004 of the Commissions public notice, we also request temporary confidential treatment of information accompanying this application as outlined below for an initial period of 180 days. Sincerely, Magorzata Polak-nigurowicz (Czosnw, POLAND)

Elproma Elektronika Sp. z o.o. Sep. 23, 2021 Timco Engineering, Inc. 849 N.W. State Road 45 P.O. Box 370a Newberry, Florida 32669 USA Letter of Authorization We, the undersigned, hereby authorize Yeong Hwan Hong of ICR Co.,Ltd. to act on our behalf in all manners relating to application for equipment authorization for FCC ID: 2A277TOLOGG33 including signing of all documents relating to these matters. Any and all acts carried out by Yeong Hwan Hong of ICR Co.,Ltd. on our behalf shall have the same affect as acts of our own. This authorization is valid until further written notice from Elproma Elektronika Sp. z o.o. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Sincerely, Malgorzata / Authorized representative