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Contents 1 MODsense Overview ............................................................................................... 3 2 MODsense Dashboard ............................................................................................ 4 2.1 Account Setup.................................................................................................... 4 2.2 Initial Setup......................................................................................................... 6 2.3 Shipment Monitoring .......................................................................................... 14 2.4 Account Settings ................................................................................................ 23 3 MODsense T Logger................................................................................................ 24 3.1 LED Patterns ...................................................................................................... 24 4 MODsense Desktop App......................................................................................... 27 4.1 Send and Receive Shipments ............................................................................ 27 4.2 App Settings....................................................................................................... 35 5 MODsense Mobile App............................................................................................ 38 5.1 Send Shipment................................................................................................... 38 5.2 Receive Shipment .............................................................................................. 43 5.3 Shipment History................................................................................................ 47 5.4 Offline Case ........................................................................................................ 48 5.5 Changing Environments ..................................................................................... 51 6 Error Handling & Support........................................................................................ 52 7 Technical Data.......................................................................................................... 53 7.1 Device Specifications ......................................................................................... 53 7.2 Operating Conditions ......................................................................................... 54 7.3 Measuring Parameters & Settings, Customizable for Each Shipment ............... 54 8 Important Instructions............................................................................................. 55 1. MODsense Overview MODsense helps you monitor the temperature of your goods while they are in transit. Adverse environmental conditions can damage pharmaceutical (and other) products if they are exposed to temperatures that are too high or too low. This exposure may make them become ineffective. Here is where we can help. Monitoring begins in the MODsense dashboard, where you can set up your shipment profiles and specify your monitoring criteria. Here you can also configure automatic alarms that are sent to users by email or by text message. When your goods are ready to be packed, you can start the MODsense T data logger using an NFC pad or the MODsense mobile application. The logger is then packed with the goods and it starts recording the temperatures using the settings from your shipment profile. When the shipment is received, the data can be read from the logger simply by scanning the shipment ID on the package, meaning that there is no need to open the package. The data from the logger is now available on the MODsense dashboard, where you can evaluate it to see whether the temperature conditions have been met. With the help of blockchain technology, your data is secure and available for regulatory reporting. Related information:
MODsense Dashboard (Page 4) MODsense T Logger (Page 24) MODsense Desktop App (Page 27) MODsense Mobile App (Page 38) Page 3 of 59 2. MODsense Dashboard The temperature-monitoring process starts in the MODsense dashboard. If you are the administrator at your company and you are setting up MODsense for the first time, you need to set up your account and then proceed with the initial setup. Otherwise, you can simply set up your account and get started with MODsense. 2.1. Account Setup Prerequisites:
About this task:
You have received an email invitation to access the MODsense system. Before you can work with the MODsense dashboard, desktop app, or mobile app, you need to set up your account so that you can log into the applications. All of the applications (dashboard, mobile app, and desktop app) use the same login credentials. Proceed as follows:
1. Click the link in your email invitation to go to the MODsense account setup screen. 2. Enter your first and last name. 3. Enter and confirm your password. 4. Accept the End User License Agreement and Privacy Declaration by clicking the checkbox. Page 4 of 59 5. Click Conrm to setup your account. 6. Enter your email and password on the next page to log in to the dashboard. Note:
If you enter your mobile phone number, you can receive alarms via text message. You can add or change your phone number in your user settings at any time. Page 5 of 59 2.2. Initial Setup About this task:
As an administrator, you first configure the system. Proceed as follows:
1. Assign Roles and Permissions Page (Page 7). 2. Invite Users to MODsense (Page 9). 3. Set up Shipment Profiles (Page 10). 4. Define Alarm Recipients (Page 11). Result:
After you have configured these settings, you can change them at any time on the Conguration tab. Page 6 of 59 2.2.1. Assign Roles and Permissions Page About this task:
Access to the functions of the MODsense dashboard, desktop app, and mobile app is controlled by a set of roles and permissions. By default, there are four roles available in the system:
Administrators have full access to all of the functions and features offered by MODsense. Operators are generally responsible for sending and receiving shipments. They are authorized to start and read the loggers. Qualied persons review the recorded data on the MODsense dashboard and decide whether a shipment can be accepted. Viewers can display and export shipments in various data formats. Each role is associated with a number of permissions, which govern the activities that users with the assigned role can perform. You can add or remove permissions from a role as required, or even create a new role. Proceed as follows:
1. Click Manage Role. 2. To add a role:
a. Enter a name for your new role. b. Click Add. Page 7 of 59 c. Click Add and close the Manage Roles window. d. Set the checkmarks for each permission that you want to assign to a role. 3. To delete a role, click the trash can next to the name of the role. Note:
The admin role cannot be changed or deleted. You cannot delete a role if it is assigned to a user. The permissions are predefined by the system. You cannot create your own permissions. Page 8 of 59 2.2.2. Invite Users to MODsense About this task:
Everybody who uses the MODsense dashboard, desktop app, or mobile app needs an account. You add users by sending them an account invite. Proceed as follows:
1. Click Add User. 2. Choose a User Role. 4. Click Add User. 3. Enter the email address of the person you want to invite. Result:
The persons you have invited automatically receive an email with a link they can click to set up their account. As soon as a user has set up an account, the user status changes from Pending invite to Active. Page 9 of 59 2.2.3. Set up Shipment Proles About this task:
Shipment profiles contain the parameters, alarm criteria, and other settings that can be applied to a shipment. They are usually defined by the qualified persons responsible for ensuring that the temperature range is maintained during transit. When the logger is started, the operator or picker assigns the shipment profile to the logger and to the package that is to be shipped. Proceed as follows:
1. Shipment Profile Name: Enter a unique name for the shipment profile. 2. Temperature Range: Specify the upper and lower limits of the temperature range. 3. Recording Interval: Specify how many times per minute the temperature should be 4. Expected Maximum Transport Duration: Specify the expected maximum transport recorded. duration of the shipment. 5. Define advanced settings:
Deviation alarms: Set the values for permissible deviations Measurement Characteristics: Initial recording delay and outlier smoothing 6. Temperature Deviation Indication: Specify whether the alarm is displayed on the logger, and/or in the mobile app after the data has been read (see LED Patterns
(Page 24)). 7. Save your settings. Result:
Once you have set up a shipment profile, it is listed under Shipment Proles on the Conguration tab. The shipment profile is then also available in the desktop and mobile app for sending shipments. There you will also find the associated QR code, which you can print out and use when sending shipments with the MODsense desktop app (see Send and Receive Shipments (Page 27)). Page 10 of 59 2.2.4. Dene Alarm Recipients About this task:
If a shipment deviation occurred, you can arrange for appointed users to be notified. The users are notified by email or text message. All active shipment profiles are listed. Alarm recipients and alarm types can be assigned to each shipment profile. Proceed as follows:
1. Click the configuration symbol of the shipment profile to which you want to add one or more alarm recipients. 2. Find the user you want to activate as an alarm recipient. Page 11 of 59 3. By clicking the respective alarm type symbol, you can determine whether this user will be notified by text message and/or email. The selected alarm types will be highlighted blue. Note:
The text message alarm symbol will be inactive and grayed out if no mobile phone number was entered in the user profile. More information can be found at User Accounts (Page 21). Page 12 of 59 4. If desired, add more alarm recipients. 5. Click Close. Result:
Click the arrow symbol to review the current configuration. Note:
The system only sends notifications to active user profiles. Users with pending invitations do not receive alarms. Deactivated alarms increase the risk of undetected shipment deviations. Page 13 of 59 2.3. Shipment Monitoring The MODsense dashboard helps you to keep track of your shipments. You can use it to monitor the shipments in your company, and it enables you to investigate shipments for which a temperature deviation has been recorded. 2.3.1. Deviations Deviations are defined as shipments whose recorded temperatures are outside the temperature range specified in the shipment profile in addition to shipments with erroneous data or exceeded transport duration. At the top of the Deviations tab, all of the deviations are shown. These are grouped according to the following criteria:
Shipments with temperature deviation Erroneous shipments Shipments with missing data You can click on any of these areas to access the shipments list filtered according to these criteria. In addition, you can see your personal alarms at the bottom of the page and click on any alarm to see the corresponding shipment details page. Page 14 of 59 2.3.2. Shipments Shipment List Shipment details provide you with a range of in-depth data on shipments that are in progress or that have been completed. They can be used for information purposes or as a basis for taking corrective or follow-up action. The Shipments area of the dashboard lists all of the shipments for your company. Here, you can view the most important data such as the shipment status, ID, dispatch and receipt dates, and the shipment profile that was applied. You can also filter this list by date, shipment status, and shipment profile, or you can search for a specific shipment ID in the Find Shipments box. It is also possible to search the shipment list by the loggerss MAC address. Page 15 of 59 Shipment Details You can access the shipment details in any of the following ways:
Click Deviations and, under My Alarms, click the entry for which you require more details. Note:
You can see only the alarms you have been notified about. Click Deviations and one of the options under Company Overview to access the list of shipments. Then click Show to view the details of the shipment in which you are interested. Click Shipments to access an unfiltered list of shipments, and then click Show for the shipment you are interested in. The information on the Shipment Details screen depends on the status of the shipment and on your user role. Page 16 of 59 2.3.2.1. Shipment Statuses A shipment can have any of the following statuses:
Compliant Non-Compliant In Transit All the parameters defined in the shipment profile were adhered to or the status has been changed by the user. Certain parameters defined in the shipment profile were violated. The violated parameters are indicated in the Shipment Deviations section. This status can be set by the user only. While a shipment is in transit, the temperature curve is not displayed, and no data is shown in either the shipment deviations or the shipment statistics. Examination Required Missing Data Due to a temperature deviation while the shipment was being transported, you are required to set the shipment status to Compliant or Non-Compliant. The expected shipment duration has exceeded but the logger data has not been read. You can change the shipment status to Missing Data Acknowledged. Missing Data Acknowledged Shipment data is unavailable. This status can only be set by the user. If the shipment data arrives at a later point in time, the status will be updated automatically. Erroneous Error Acknowledged A problem with the logger has occurred, which requires the attention of customer support. You can change the shipment status to Error Acknowledged. Shipment data is unavailable. This status can only be set by the user. Page 17 of 59 2.3.2.2. Shipment Deviation Handling Shipment deviations need to be manually reviewed in the MODsense dashboard. All shipments with deviations are shown in the Deviations page. An orange banner with a corresponding deviation message is displayed on the shipment details page. Shipments with temperature deviations Shipments with temperature deviations display a status of Examination Required. These shipments have to be investigated and declared compliant or non-compliant. The shipment compliance can be declared using the buttons in the orange banner on the shipment details page. After declaring the compliance, the orange banner disappears and the shipment is no longer displayed on the Deviations page. Proceed as follows:
1. Click the corresponding button in the orange banner. 2. Enter the reason for your selection and if your company requires additional verification for this step, then you will need to enter in your individual pin as well. 3. Click the button to confirm your entry. Note:
The indication of conformity relates to the defined parameters in the shipment profile. Page 18 of 59 Shipments with temperature deviations Shipments with missing shipment data will have a status of Missing Data. These shipment deviations can be confirmed in the orange banner on the shipment details page. After confirming the missing shipment data, the shipment is no longer displayed on the Deviations page. If the shipment data arrives in the system at a later time, the shipment status is automatically updated. Shipments with erroneous data Shipments with erroneous shipment data are set to a status of Erroneous. This status is a fallback scenario and should never occur. Please contact us at support@modum.io if this case occurs. The shipment is no longer displayed on the Deviations page after acknowledging the erroneous shipment data. 2.3.2.3. Temperature Curve The temperature curve is a graphical representation of the temperature variations that occur during a shipment. If the temperature remains within the defined temperature range, the curve is green. As soon as the defined temperature range is violated, the curve turns red. It turns green Page 19 of 59 again if the temperature returns to within the defined temperature range. If the Outlier Smoothing option has been activated in the shipment profile, you can choose between the views Smoothed Data and Raw Data:
Alarm criteria are based on a moving average of the specified number of readings. This has the effect that single outliers have a reduced impact on the assessment of deviations. This view shows all of the recorded temperature readings. Smoothed Data Raw Data Note:
For shipments sent by Swiss Post, the temperature curve and events from the Track consignments online service are shown in the graph. The events are also listed in the change & comments log. 2.3.2.4. Change & Comments Log If your user role contains the permission Add Comments, you can enter comments on a given shipment in the Change & Comments Log. The log also shows shipment status updates that are generated automatically by the system. The entries in the Change & Comments Log cannot be edited or deleted. Note:
2.3.2.5. Reports If you want to generate a report (for example, for regulatory reporting), you can do so by clicking Generate Report on the Shipment Details screen. The report contains all of the information from the shipment, and you can choose whether to include entries from the Change & Comments Log. You can generate reports in PDF, CSV, or Microsoft Excel format. Page 20 of 59 2.3.3. Conguration Shipment Proles The Conguration area of the dashboard allows administrators to change the system setup. The Shipment Proles tab lists all of the shipment profiles that are available in the system. From here, you can add, edit or delete profiles, view the details of each profile, and print the QR code to use with the desktop app (see Send and Receive Shipments
(Page 27)). Note:
You cannot reinstate a shipment profile after having deleted it. You can delete a shipment profile at any time. All shipment profile names must be unique regardless of whether they are active or have been deleted. For this reason, you cannot reuse the name of a deleted shipment profile. On the Alarm Recipients tab, you can specify which users receive an alarm if the parameters in a shipment profile are violated. Users can receive an alarm by email, and if they have entered a mobile phone number in their user profiles, they can also receive an alarm by text message. Alarm Recipients User Accounts The User Accounts area allows you to manage the users data in your organization. For example, you can change a users role, name, or email address. You can also delete and reactivate users or revoke passwords from here. The overview page shows the status of each user: active users have accepted their email invitation, whereas pending invite users have received the invitation but did not set up their account yet. Roles and Permissions The Roles and Permissions tab allows you to manage the roles and permissions that are available in your system. For more information, see Assign Roles and Permissions Page
(Page 7). Page 21 of 59 Custom Fields The Custom Fields area allows you to manage the custom fields in your organization. You can add new or change existing fields. Custom fields are shown as Additional Information on all shipment details pages and in shipment reports. Users with List All Shipments and List Received Shipments permission can add data to the custom fields on shipment details pages. 2.3.4. Audit Trail All actions and events are listed in the audit trail. Each entry is displayed with a unique identification number, time stamp, event, category, and changed data. As an administrator, you can view the audit trail and generate a report in CSV format. Page 22 of 59 2.4. Account Settings You can access your account settings by clicking the profile icon at the top right of the screen. In your account settings, you can change your first name, last name, and mobile phone number. You can also select your preferred language and change your password. Page 23 of 59 3. MODsense T Logger The MODsense T logger consists of four main areas:
1. Three LED lights indicate the operating status, conformity with set conditions, and the logger status. For more information about the meaning of each LED, see LED Patterns (Page 24). 2. Wake-up button 3. QR code used when sending a shipment via the mobile app. For more information, see Send Shipment (Page 38). 4. Data about the logger itself, such as its unique ID and expiry date. Related information:
LED Patterns (Page 24) Technical Data (Page 53) Compliance Statements (Page 57) 3.1. LED Patterns Under normal circumstances, the LEDs on the logger are switched off. When the logger has been activated or when you press the wake-up button, the following LED patterns can be shown on the logger. Page 24 of 59 Note:
If you press the wake-up button, all three LEDs flash briefly. If this is not the case, please return the logger to Modum. Pattern Status Meaning
(2 minutes) Ready for synchronization If the logger is in standby and you press the wake-up button, the middle LED flashes green for two minutes. During this time the logger is waiting to be activated via Bluetooth. If it is not activated, the logger returns to standby. Logger successfully activated All three LEDs flash for 10 seconds. The logger has been successfully activated and will start recording after the defined delay. Temperature logging
(10 seconds)
(5 seconds)
(5 seconds)
(5 seconds)
(5 seconds)
(5 seconds) Temperature deviation Error or low battery Temperature deviation and error Power saving If you press the wake-up button and the middle LED lights up green for 5 seconds, the logger is recording the temperature. Either no temperature deviation has been detected or the temperature deviation alarm has been disabled. If you press the wake-up button and the left and middle LEDs light up red and green respectively for five seconds, temperature deviations have been recorded. If you press the wake-up button and the middle and right LEDs light up green and red respectively for five seconds, there is an error with the logger. For example, the memory may be full or the battery may be low. If you press the wake-up button and all LEDs light up for five seconds, temperature deviations have been detected and there is an error with the logger. If you press the wake-up button and the right LED lights up red for five seconds, the logger has switched to power-saving mode. It does so whenever the temperature drops below freezing. Page 25 of 59 Return logger If you press the wake-up button and none of the three LEDs flashes or lights up, the battery is empty. Please return the logger to Modum. Note:
The logger LEDs are indicative only. They should not be used as the basis for your process decisions. Page 26 of 59 4. MODsense Desktop App You can send and receive shipments and see latest activities using the MODsense desktop app, which is available from the modum Help Center at https://support.modum.io If you are a Swiss Post customer, you will only need to take care of starting the loggers (4.1.1). The Swiss Post will read out the loggers for you when the shipment arrives at the final destination. 4.1. Send and Receive Shipments Prerequisites:
You have downloaded the MODsense desktop app from the modum Help Center at https://support.modum.io You have a suitable NFC pad. You have turned on bluetooth. You have a suitable barcode scanner. (optional) You have printed out the QR code for the shipment profile. (optional) Your MODsense desktop app is connected to the internet. Note:
Note:
Please do not leave loggers on the NFC pad after usage as it will shorten battery live. Page 27 of 59 Proceed as follows:
1. Log on to the MODsense desktop app. 2. Click on Send, Receive or History in the navigation on the left side. Page 28 of 59 4.1.1. Send 1. Place the logger on the NFC pad. 2. Scan the shipment ID on the package or enter it manually. (The shipment ID on the package contains the barcode with the tracking number of the logistics provider.) Scan shipment ID:
Page 29 of 59 Enter manually:
The left side of the screen turns green indicating that the shipment ID was scanned or entered successfully. 3. Scan the QR code of the shipment profile or choose the shipment profile from the list. The right side of the screen turns green indicating that the shipment profile has Page 30 of 59 been entered successfully. The desktop app checks the loggers battery level and its expiry date before the logger is activated. This ensures that the battery power is sufficient for the planned shipment duration and that the loggers expiry date will not exceed. In case the battery is too low, an error message is displayed. The logger activation starts automatically after your confirmation. 4. The logger is now activated and can be packed. Page 31 of 59 4.1.2. Receive 1. Place the logger on the NFC pad and confirm with Receive. 2. Wait until the logger has been completely read out. Page 32 of 59 3. The logger has been read and can be reused. Click on View Details Online to get more information about the recorded data. Note:
If an error occurs while generating or receiving a shipment, follow the instructions on the screen. For further support, visit our Help Center at https://support.modum.io. Page 33 of 59 4.1.3. History Click in the navigation left on History to show the latest activities. Page 34 of 59 4.2. App Settings You can access your app settings by clicking settings at the bottom left of the screen. In your app settings, you can activate shipment ID format validation and set a default shipment profile. 4.2.1. Shipment ID Format Validation You can restrict the MODsense desktop application to only accept barcodes that look like your carriers track and trace number. Click on one or several formats to activate the validation. The activated formats will be highlighted blue. If you dont select anything, every shipment ID will be accepted. 4.2.2. Default Shipment Prole You can set a default shipment profile for the specific desktop application station to simplify the commissioning process. Click on the profile you want to set as a default. The selected profile will be highlighted blue. Page 35 of 59 4.2.3. Precongure Loggers You can prepare loggers with default shipment profiles and shipment IDs to simplify the commissioning process. Note:
The app settings are local settings and apply only for the specific desktop application station. They are not linked to the currently logged in user account. Page 36 of 59 4.2.4. Changing Environments On the login page there is the possibility to change the system environment. Click on Change environment to show the environments. The Trial environment can only be used to get to know and test new features before they are available in production. The environments are not linked and there is no exchange of shipment data and no sharing of user accounts. Note:
Use the trial environment for evaluation and to get to know our system. Please use the production environment for your quality controlled shipments. Page 37 of 59 5. MODsense Mobile App You can use the mobile app to send and receive shipments. The app can be downloaded from the Google Play Store or from the Apple App Store. Note:
If you are a Swiss Post customer, you will only need to take care of starting the loggers (5.1). The Swiss Post will read out the loggers for you when the shipment arrives at the final destination. 5.1. Send Shipment 1. Open the mobile app and log in. Page 38 of 59 2. Tap the Send shipment in the navigation bar at the bottom. 3. Press the wake up button on the logger. 4. Scan the QR code on the logger or enter it manually. Page 39 of 59 5. Scan the shipment ID or enter it manually. This contains the barcode with the tracking number of the logistics provider. 6. Select a shipment profile or scan the shipment profiles QR code. Tap Activate logger. Page 40 of 59 The app connects to the logger and checks the battery level and expiry date before the logger is activated. This ensures that the battery power is sufficient for the planned shipment duration and that the loggers expiry date will not be exceeded. The loggers activation progress is displayed. Page 41 of 59 7. The app then shows the shipment status. You can now send another shipment or view the details of your shipment online. Note:
If an error occurs while generating a shipment, please follow the instructions on the screen. For further support, please visit our Help Center at https://support.modum.io. Page 42 of 59 5.2. Receive Shipment You can use the mobile app to receive shipments and read the data. 1. Open the mobile app and log in. Page 43 of 59 2. Tap the Receive button in the navigation bar on the bottom. 3. Scan either the shipment ID on the package or the loggers QR code after removing it from the package. Page 44 of 59 The app then connects to the logger and shows the progress of the data being read. 4. A readout summary is shown. You can receive another shipment or view the details of your shipment online. Page 45 of 59 In case of a temperature deviation, a message is displayed provided that the notification of temperature deviations has not been deactivated in the shipment profile. Note:
If an error occurs while reading out a shipment, please follow the instructions on the screen. For further support, please visit our Help Center at https://support.modum.io. Page 46 of 59 5.3. Shipment History You can view the most recent sent and received items here. Tap any item and it will be expanded to display more information. To view even more details, click the More details link and you will be redirected to the MODsense dashboard items shipment page. Page 47 of 59 5.4. Oine Case You can activate or read logger data with the MODsense app without an internet connection. The shipment data is stored on the mobile phone but is not forwarded to the MODsense system until your internet connection is restored. Because of this, it is therefore not visible in the MODsense dashboard. To alleviate the temporary missing data, the MODsense mobile app should be connected to the internet whenever possible. Oine Logger Activation The shipment status page displays a warning if a logger has been activated without an internet connection. The shipment data is stored on the phone and queued. Page 48 of 59 Oine Logger Data Read The readout overview page displays a warning if a logger has been read without an internet connection. The shipment data is stored on the phone and queued. Page 49 of 59 Queued Shipment Data The number of shipments in the queue is displayed in the settings page. The shipment data is automatically uploaded as soon as the app is reconnected to the internet. The data is then immediately visible in the dashboard. Note:
Do not logout of the MODsense mobile app if you still have shipment data in the queue. If you do so, the pending shipment data will be lost when logging out of the app. Page 50 of 59 5.5. Changing Environments On the login page there is the possibility to change the system environment. Click on Change environment to show the environment switch. The trial environment can only be used to get to know and test new features before they are available in production. The two environments are not linked and there is no exchange of shipment data nor sharing of user accounts. Note:
The trial environment should only be used for evaluation kits and to get to know our system. It should not be used in a production environment. Page 51 of 59 6. Error Handling & Support Error Handling Support Releases For information about error handling, please visit the Documentation & Manuals section of our Help Center at https://support.modum.io. If you require further support, please contact us at support@modum.io. You will need to quote your authentication code, which you can find in your account settings. Comprehensive information about releases and known issues is available in the Documentation & Manuals section of our Help Center at https:/support.modum.io. Page 52 of 59 7. Technical Data 7.1. Device Specications Dimensions L x W x H 95 x 43 x 10 mm Weight Casing 22 g ABS / MABS, tamper-evident Protection Class IP 65, IP 67 Measured Parameters Temperature in C Measurement Accuracy 0.5 C within operating measurement range Maximum Storable Measurements 45,000 measurements Battery Type Li/MnO2 Coin Cell Communications Interface Bluetooth Low Energy (BLE) User Interface Repeatable Use Device Traceability Data Traceability Compliance Markings Near Field Communication (NFC) 3 LEDs: operating state, conformity with set conditions, and logger state 1 button: wake-up Unlimited within operating conditions Unique logger ID, QR tag on device Device-specific signature for data authenticity from logger to blockchain RED, RoHS, WEEE, EN 12830:2018, RTCA DO-160G CE, FCC 7.2. Operating Conditions Operating Measurement Range
-20 C to +60 C Storage Conditions
+5 C to +30 C Typical Battery Lifetime 6-12 months, depending on use case Sensor Calibration Validity (from production date) 18 months Logger Expiration Date Set and written on device 7.3. Measuring Parameters & Settings, Customiz-
able for Each Shipment Measurement Start Delay Measuring Interval Range Data Export Formats Alarm Settings 0 to 60 minutes 1 to 30 minutes PDF, CSV, Excel Multi-level, Cumulated temperature, Shipment delay Notifications Email, Text Message, Smart Contract API 8. Important Instructions For Your Safety Please note the following guidelines. Use the MODsense system exclusively for the purpose indicated in the product specifications and only under the conditions specified in this user manual. The manufacturer shall not be liable for any damages that resulted from unauthorized or incorrect utilization of the system. Battery The battery is not replaceable and must not be changed by the user. By opening the casing, the liability claim shall lapse. Process-relevant Instructions Wireless Interference Although our temperature loggers were designed, tested and manufactured according to the requirements for radio frequency emissions, all wireless devices can be exposed to performance-disturbing disruptions if they are used in proximity of strong electromagnetic forces such as power cables or overly dense wireless network connections. Spare Loggers The MODsense desktop app and the MODsense mobile app check the loggers battery level and expiry date before the logger is activated. This ensures the loggers usability for the planned shipment. Spare loggers must always be available at the commissioning location in case a logger should prove unusable. Measurement Accuracy Each temperature sensor is factory calibrated across the full operational range. Temperature measurement accuracy is validated by ISO 17025 accredited laboratories. Relevant technical documentation and specifications with test reports are available to our customers upon request. Commissioning Process If a logger is not located in the package assigned by the logistics system, the temperature data can be assigned to a wrong shipment. Therefore, the commissioning process should be designed in a way that avoids the loggers getting confused. Logger Data Read The logger data should be read from the shipment number barcode instead of the logger QR code, whenever possible. The risk of an accidental logger confusion can thereby be minimized. Safety in Air Transport As damaged loggers may pose a safety risk to the transporting aircraft, it is crucial that the loggers are in a safe condition when sent by air freight. Operating Instructions Every logger must be thoroughly inspected for physical damage before it is included in a shipment sent by air freight or affixed to a shipment sent by air freight. Loggers with visible damage such as dents, indentations, cracks or severe scratches; as well as deformed, discolored or ruptured devices must be separated and must NOT be sent by air freight. Regulatory and System Requirements Regulatory Requirements For information about regulatory requirements, please visit the Documentation &
Manuals section of our Help Center at https://support.modum.io System Requirements For information about system requirements, please visit the Documentation & Manuals section of our Help Center at https://support.modum.io. Legal Information The End User License Agreement and Privacy Declaration for the Software-as-a-Service Solution is available for download in the Legal Information section of our Help Center at https://support.modum.io. Compliance Statements Hereby, modum.io AG declares that the radio equipment type MODsense T Temperature recorder (generation 1) is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://modum.io/compliance. FCC ID: 2AU2P-T202011 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 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 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 receiver. for help. Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This statement reflects the requierements of 15.105 and 15.21. Disposal and Recycling This symbol indicates that this product and/or battery should not be disposed of with household waste. Products must be taken for separate collection at the end of their working life. For information about modum.ios recycling program and collection, visit https://modum.io/compliance/recycling. Copyright 2020 modum.io AG. All rights deserved. No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of modum.io AG. The information contained herein may be changed without prior notice. These materials are provided by modum.io AG for informational purposes only, without representation or warranty of any kind, and modum.io AG shall not be liable for errors or omissions with respect to the materials. Nothing herein should be construed as constituting warranty. modum.io AG and modum.io AG products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of modum.io AG in Switzerland. All other product and service names mentioned are the trademarks of their respective companies. Version User Manual Version 1.14
1 | LabelSmpl-Loc | ID Label/Location Info | 398.02 KiB | December 21 2020 |
REMARKS:
- all fonts are Roboto Regular
- if no position dimensions are given, approximate according to drawing EN 12830:2018 FCC ID: 2AU2P-T202011 MODsense T T 0,5 III -20 C to 60 C EXP: 2018-06-01 modum.io AG Poststrasse 5-7 8001 Zurich Switzerland 4 5.10 centered within circular cavities 31.00 8.70 18.00 elements centered on logger mid axis ID: 12:ab:34:c4:78:0f SN: V10744200052 3 font size = 8.5 pt (3 mm), 19.85 4.40 4.40 10.90 acutal visual impression of inverted QR code
(laser engraved areas appear white) Massstab 2:1 A3 Front: laser engraved, back: permanent sticker DRAFT 2018-03-26 MUT modum.io Poststrasse 5-7 CH-8001 Zrich MODsense T Logger -
Labeling Drawing - Version 3 16.00001.02 15 Version 3
1 | AutLet | Cover Letter(s) | 123.88 KiB | December 21 2020 |
4 modum Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 11/13/20 To whom it may concern:
We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: 2AU2P-T202011 including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Andreas Gawlowski Head of Quality & Compliance modum.io AG modum.io AG, Poststrasse 5-7, CH-8001 Zurich | http://modum.io 4
1 | ConReq | Cover Letter(s) | 90.71 KiB | December 21 2020 |
modum.io AG Poststrasse 5-7 8001 Zurich Switzerland modum.io info@modum.io Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 12/15/20 Request for Permanent Confidentiality Company name: modum.io AG FCC ID: 2AU2P-T202011 FCC Part 15 Certification Gentlemen, In accordance with CFR 47 0.457 and CFR 47 0.459 modum.io AG hereby requests confidentiality of following attachments:
(1) schematic diagrams,
(2) detailed block diagrams,
(3) detailed operational descriptions,
(4) parts lists These documents contain detailed system and equipment description and related information about the product which modum.io AG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, modum.io AG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Signature Andreas Gawlowski Head of Quality modum.io AG Poststrasse 5-7 8001 Zurich, Switzerland
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-12-21 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2020-12-21
|
||||
1 | Applicant's complete, legal business name |
Modum.io AG
|
||||
1 | FCC Registration Number (FRN) |
0028954949
|
||||
1 | Physical Address |
Technoparkstrasse 1
|
||||
1 |
Zurich, N/A
|
|||||
1 |
Switzerland
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
j******@eurofins.de
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AU2P
|
||||
1 | Equipment Product Code |
T202011
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
A****** G****
|
||||
1 | Title |
Head of Quality & Compliance
|
||||
1 | Telephone Number |
+4178********
|
||||
1 | Fax Number |
n.a.********
|
||||
1 |
a******@modum.io
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
modum.io AG
|
||||
1 | Name |
T**** M****
|
||||
1 | Physical Address |
Poststrasse 5-7
|
||||
1 |
Zurich, 8004
|
|||||
1 |
Switzerland
|
|||||
1 | Telephone Number |
+41 4********
|
||||
1 |
t******@modum.io
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
modum.io AG
|
||||
1 | Name |
A******** G********
|
||||
1 | Physical Address |
Poststrasse 5-7
|
||||
1 |
Zurich
|
|||||
1 |
Switzerland
|
|||||
1 | Telephone Number |
+41 4********
|
||||
1 |
a******@modum.io
|
|||||
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?: | No | ||||
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 | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | MODsense TXX | ||||
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 | Grant Comments | Output power listed is conducted. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 5 mm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. | ||||
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 |
Eurofins Electric & Electronic Product Testing AG
|
||||
1 | Name |
J******** B****
|
||||
1 | Telephone Number |
41 58********
|
||||
1 |
J******@eurofins.ch
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0017500 |
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