Contents 1 MODsense Overview ............................................................................................... 3 2 MODsense Dashboard ............................................................................................ 4 2.1 Account Setup.................................................................................................... 4 2.2 Initial Setup......................................................................................................... 6 2.
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.
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: You have received an email invitation to access the MODsense system.
. Click Confirm 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.
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 Configuration tab.
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.
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.
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. 3. Enter the email address of the person you want to invite. 4. Click Add User. Result: The persons you have invited automatically receive an email with a link they can click to set up their account.
2.2.3. Set up Shipment Profiles 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.
2.2.4. Define 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.
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).
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.
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.
2.3.2. Shipments 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. Shipment List 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.
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.
2.3.2.1. Shipment Statuses A shipment can have any of the following statuses: • Compliant All the parameters defined in the shipment profile were adhered to or the status has been changed by the user. • Non-Compliant 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.
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.
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.
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: • Smoothed 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. • Raw Data This view shows all of the recorded temperature readings.
2.3.3. Configuration The Configuration area of the dashboard allows administrators to change the system setup. Shipment Profiles The Shipment Profiles 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.
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.
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.
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.
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 (2 minutes) (10 seconds) Status Meaning 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.
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.
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 Note: 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.
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.
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.
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.
been entered successfully. The desktop app checks the logger’s 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 logger’s 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.
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.
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.
4.1.3. History Click in the navigation left on History to show the latest activities.
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 carrier’s track and trace number. Click on one or several formats to activate the validation. The activated formats will be highlighted blue.
4.2.3. Preconfigure 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.
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.
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.
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.
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 profile’s QR code. Tap Activate logger.
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 logger’s expiry date will not be exceeded. The logger’s activation progress is displayed.
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.
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.
2. Tap the Receive button in the navigation bar on the bottom. 3. Scan either the shipment ID on the package or the logger’s QR code after removing it from the package.
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.
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.
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 item’s shipment page.
5.4. Offline 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.
Offline 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.
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.
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.
6. Error Handling & Support Error Handling For information about error handling, please visit the “Documentation & Manuals” section of our Help Center at https://support.modum.io. Support 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.
7. Technical Data 7.1. Device Specifications Dimensions L x W x H 95 x 43 x 10 mm Weight 22 g Casing ABS / MABS, tamper-evident Protection Class IP 65, IP 67 Measured Parameters Temperature in °C Measurement Accuracy ±0.
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.
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.
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.
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.
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.io’s recycling program and collection, visit https://modum.io/compliance/recycling.
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