PROOF OF CONCEPT — NOT FOR CLINICAL USE — internal testing only

Kiosk Only — Installation Qualification

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Installation Details

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Kiosk Installation Qualification Checklist

General

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Are there sufficient emergency power outlets (electrical mains) in the location? There are sufficient emergency power outlets.
2 Compliant electrical specifications. The Kiosk requires 120-240v power at the fridge location and must be designed to work with a single-phase power system having a grounded neutral conductor. Power supply is sufficient.

Kiosks – Hardware Requirements

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Must not be near heat sources or air conditioning sources. The installation location is not near a heat source or an air conditioning system.
2 Must not be in direct sunlight. The Kiosk is not installed in direct sunlight.
3 Must be in a dust-free environment. The environment is substantially dust-free.

Parts Required for Installation

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Kiosk. Kiosk is present and suitable.
2 Manufacturer supplied power cable. Power cable is present, suitable, and securely connected.
3 USB cable for printer—ensure the cable is long enough to reach the Kiosk. USB cable is present and suitable if required for a printer.
4 Uninterruptible Power Supply (UPS) (if required). 575VA/345W or better capacity.
5 Ethernet network connection for the Kiosk to communicate with the BloodTrack Server. An Ethernet network port is available and suitable near the installation location.
6 Printer (if required). Printer is present.
7 External lock(s), relay cable(s) and relay port adaptor (if applicable) External lock(s), relay cable(s) and relay port adaptor are present. Document the external lock in the Comments
8 Serial cable(s), serial port adapter (if applicable) Serial cable(s), and serial port adapter are present.

Kiosks – Hardware Installation

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Ensure that the wall or desktop surface will safely support at least four times the combined weight of all attached equipment and hardware. Kiosk V5: Kiosk Only: 9.9 lbs. / 4.5 kg With shelf: 10.8 lbs. / 4.9 kg With stand: 20.5 lbs. / 9.3 kg Kiosk V6: 13.67lbs. / 6.2 kg For Kiosk V5: Wall supports 84 lbs. / 38 kg For Kiosk V6: Wall supports 56 lbs / 25kg
2 Is the Kiosk mounted to wall or table properly? Kiosk is firmly mounted to wall/table.
3 Are cables secured appropriately? Cables are secured by ties or trunking.
4 If UPS is planned to be used, is the UPS connected properly and the Kiosk attached to the battery-protected supply? UPS is plugged into the emergency power supply, connected and powering Kiosk.
5 Does the scanner have the correct configuration to scan the user ID barcodes? User ID barcodes can be scanned.
6 Does the scanner have the correct configuration to scan the hospital blood bags? Blood bag barcodes can be scanned.
7 Does the Kiosk have the correct Regional Settings? Regional Settings are correct.
8 Are the Keyboard Settings correct for the configured Region? Keyboard Settings are correct.
9 Is the external lock set properly fitted (if applicable)? Locks firmly fixed to storage location (where applicable).
10 Storage device lock test passed in the Storage device Installation Qualification? Storage device lock test passed.

General

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 To install the BloodTrack Courier® Software, sufficient local administrative rights must be provided to the Haemonetics installer. These can be provided locally, as part of a workgroup or domain. If adding to domain, and the Hospital IT department has disabled the standard local accounts, the Hospital IT department must provide the login details. Sufficient rights have been obtained.

Third-Party Software Requirements – Kiosks

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Installation media checked with an anti-virus tool to ensure it is virus-free. Installation media is virus-free.
2 Necessary users are created or configured. (List user names in the Comments field.) Local administrator is created or configured. Local user is created or configured (if necessary).
3 The local user accounts are set so that the passwords never expire. The account passwords will never expire.
4 The local Courier auto-log-in user account is set to be able to change regional/date and time settings. The user account must have the group policy assigned to “Change the system time”. This user has these rights.
5 The group policy for the local Courier auto-log-in user account does not include a pre-logon message. Group policy for this user does not include a pre-logon message.
6 The local user account has read/write access to the Neoteric folder(s) and all sub-folders. This user has these rights.
7 The local user account is set to be able to browse the network. This user has these rights.
8 Local user account is added to domain or appropriate workgroup. Local user account added to domain/workgroup.
9 If added to domain, ensure the Kiosk is assigned to an Active Directory (AD) Organizational Unit (OU) such that it does not receive automatic software installations as a regular computer may, and also does not require CTRL+ALT+DEL to login, etc. Kiosk assigned to an AD OU, and does not receive software updates for end user workstations.
10 If added to domain, domain users are added to local administrators group as is necessary. Domain users added to local administrators group.
11 (Applicable to Kiosk V5 only) The touch screen is calibrated properly with the touch-screen utility. Touch-screen correctly calibrated.
12 If an antivirus software is supplied and installed by customer. The antivirus must be configured to bypass the following paths: C:\Program Files (x86)\Neoteric and its subfolders C:\ProgramData\Neoteric and its subfolders Note: It is the responsibility of the hospital IT Department to ensure that the antivirus is set to automatically update properly. Antivirus package installed by customer and configured appropriately.
13 If UltraVNC is used, the antivirus rules must allow UltraVNC UltraVNC is allowed in the antivirus rules.
14 Windows updates are configured as agreed with customer IT department and the Blood Bank Manager. Windows updates configured as noted.
15 Set the Host Name of the Kiosk based on the Installation Details section.. Kiosk Host Name is set per the Installation Details section
16 The printer is installed correctly (if required) using the appropriate printer driver. Printer is installed and connected to the Kiosk.  Printer is successfully added to Printers & Faxes/ Devices and Printers on the Kiosk with the correct driver.
17 Printer is connected to power and USB. Printer turns on. Enable printer’s auto-on feature if available. Printer is connected to USB and powered on. Printer’s auto-on feature is enabled if available.
18 The Keyboard layout in Microsoft Windows is set to one of the supported layouts The keyboard layout is set to one of the following layouts: English – US English – UK French – France German – Germany Italian – Italy Spanish - Spain
19 Onscreen keyboard runs. Settings changed to appropriate keyboard layout (for example, 102 key layout). Keyboard layout is configured.
20 Configure Timezone. Timezone is configured.
21 Confirm Auto start is configured. Auto start is working, i.e. kiosk powers on when power is supplied without having to turn on a kiosk power switch.
22 Windows Firewall Service is configured to allow client-server communication properly. (List configuration properties in Comments field.) Windows Firewall is configured and Kiosk can communicate with the BloodTrack server.
23 Add the following shortcuts to Quick Launch toolbar/taskbar: Command prompt shortcut Onscreen keyboard shortcut File Explorer shortcut Command prompt shortcut, onscreen keyboard shortcut and File Explorer shortcut are added to Quick Launch toolbar/taskbar.
24 Windows Folder options configured appropriately. Windows folder options are set to: show hidden files and folders, extensions and protected operations system files.
25 Remote support application is installed appropriately for support of client devices. (List applications in Comments field.) Application is installed and configured to connect to clients and to allow internal remote connections from Haemonetics.
26 In the Kiosk Control Center, ensure custom shell is disabled for standard users. Custom shell is disabled for standard users.
27 In the Kiosk Control Center, ensure “Do Nothing” is selected as the “Default action when monitored application exits” “Do Nothing” is selected as the “Default action when monitored application exits” in the Kiosk Control Center.
28 In the Kiosk Control Center, setup and enable Auto Logon. Auto Logon is configured in the Kiosk Control Center.
29 (Kiosk V6 Only) In the Kiosk Control Center, ensure Crash Log Reporting consent is not checked in Crash Log Reporting checkbox is not checked in the Kiosk Control Center.
30 Kiosk Monitor is configured to always remain active, and does not enter standby, hibernation, or any power-saving mode. Kiosk Monitor is configured to always remain active.
31 Auto-mute on Kiosk start-up is disabled. Auto-mute is disabled.

Installing the BloodTrack Software

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Install BloodTrack Courier Software . BloodTrack Courier Software is installed with correct server IP address and port.
2 Verify that the application installed to %PROGRAMFILES%\Neoteric\BloodTrack Courier. Applications are installed properly.
3 Ensure that the ksn.txt file containing the Kiosk inventory number is created and placed in the root directory; for example, C:\ksn.txt. The ksn.txt file is in the root directory.
4 Verify that the BloodTrack Courier Configuration Profile is configured for the Kiosk and the storage location is configured within both the ASK Manager system and the BloodTrack Manager® Software in the Blood Bank. The Kiosk and the storage location are configured.
5 Launch the BloodTrack Courier Software. Confirm that the ‘Scan Your Identification’ screen displays. Touch the top left corner of the screen. Confirm it is the correct version. The client software is the correct version.
6 Verify that the BloodTrack Server IP address set during installation matches the IP Address value or DNS name configured in the Courier.ini file. The IP address is correct.
7 The BloodTrack Courier Software is configured with correct printer and label templates (if required). The BloodTrack Courier Software is configured with correct printer and label templates and successfully prints test printouts.
8 Open the local configuration screen. Test that the door lock operation is working correctly. Door locks locking and unlocking appropriately.
9 Exit the BloodTrack Courier Software using the configured exit password. Confirm the Kiosk displays the Windows desktop. The password worked correctly and the Kiosk displays the Windows desktop.

Password Management

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Default password for the Windows local user accounts (haemonetics and generic) are not to be shared. If the customer needs access to the local administrative user account, the password must be changed to a uniquely generated password. The new password must be recorded in Haemonetics password vault system. *The password for the default local administrative user must not be shared with the customer, it is for Haemonetics use only. Password for the Windows local administrative user account is updated and stored in the password vault system.
2 If customer does not have an administrative user account through Active Directory, an additional local administrative user account must be created, the initial password must be uniquely generated. This password must be recorded in Haemonetics password vault system and shared with the customer. Password for the new Windows local administrative user account is created and stored in the password vault system in the customer file, and shared with the customer.
3 The default password for UltraVNC must be changed to a uniquely generated password. The new password must be recorded in Haemonetics password vault system. Password for UltraVNC is changed and stored in the password vault system in the customer file. The new password is shared with the customer if applicable.
Installer Comments
Incident Report Reference(s), if installation failed
Attachment ReferenceDescriptionNumber of Pages
Overall Result

Customer Acceptance (Declaration of Conformity)

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