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

HaemoBank 20 (Rev5 Kiosk) — Installation Qualification

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Installation Details

Installer Signature

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Testing Equipment

HaemoBank 20 Device Installation Qualification Checklist (v16)

Location Requirements

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Ensure location will accommodate the HaemoBank 20 device dimensions: External dimensions (W x D x H): 29.33 in. x 34.37 in. x 31.78 in. (744 mm x 874 mm x 808 mm) For counter-top installations, ensure the counter-top can safely support a minimum of 425 lbs. (193 kg) and has a minimum of 30 in. (763 mm) depth. For under-counter installations, ensure there is a clearance 30.25 in. (width) x 34.25 in. (height) (768 mm x 870 mm). Location will accommodate the HaemoBank device.
2 Ensure the location will accommodate the BloodTrack® Kiosk V5 dimensions—refer to the BloodTrack Kiosk Installation Qualification Checklist. Location will accommodate the BloodTrack Kiosk V5.
3 Must be kept clear of direct sunlight, high temperature heat sources, heating vents and air conditioning vents. The installation location is not near direct sunlight, heat source or an air conditioning vent.
4 Must be in a dust-free environment. The environment is substantially dust-free.
5 For a stacked configuration, ensure that both devices have leveling feet, back brace bars and front stabilizing brackets are installed. Stacked HaemoBank devices have leveling feet, back brace bars and front stabilizing brackets installed.
6 Must be sufficient space for cleaning and maintenance. The HaemoBank device has space around it for cleaning/ maintenance.
7 Must not be positioned in narrow areas that disrupt airflow. The HaemoBank device is in a well-ventilated area.
8 Ensure the ambient temperature is between 15 °C to 32 °C and relative humidity is 80% (for Temperature up to 31 °C) decreasing linearly to 50% (at 40 °C). The ambient temperature and relative humidity is within specified range.
9 Must be on a level surface. The HaemoBank device is located on a level surface.

Electrical Requirements

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 It is strongly recommended that the HaemoBank device be connected to the emergency power system. The HaemoBank device is connected to the emergency power system.
2 The HaemoBank device must be within 3 feet (1 metre) of an electrical outlet. The HaemoBank device must not be installed with a permanent electrical supply feed that cannot be disconnected. The HaemoBank device is the appropriate distance from an electrical outlet.
3 Ensure that the voltage and frequency of the power source matches the voltage and frequency inscribed on the HaemoBank device electrical rating label: EU: 230V / 50 Hz NA: 115V / 60 Hz 230V / 60 Hz Power voltage and frequency match HaemoBank device electrical rating label.
4 Do not use extension cords or adapters to connect the HaemoBank device to the main power supply. The HaemoBank device is safely connected to the main power supply.

Setting up the HaemoBank device

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Transportation within the location must be arranged (for example, pallet truck, forklift, etc.). Suitable transportation is available.
2 Consider the weight of the HaemoBank device before moving it. Net weight device: 307 lbs. (139.26 kg) Net weight device with shipping carton: 610 lbs. (276.7 kg) Transport method can safely transport the specified weights.
3 The HaemoBank device should never be in any position except the upright position. Ensure the HaemoBank device has been in an upright position for at least 24 hours following shipping. Stored appropriately.
4 Use extreme caution when using heavy machinery (for example, forklift, pallet jack, etc.) to move the HaemoBank device. HaemoBank device moved safely.
5 Move the HaemoBank device slowly. HaemoBank device moved appropriately.
6 Before un-crating the HaemoBank device, check that it has not been damaged during transport. HaemoBank device appears undamaged prior to un-crating.
7 Un-crate the HaemoBank device. Remove tape and all packaging material. HaemoBank device un-crated appropriately.
8 Remove the accessory package from the device and store all materials from the package in a secure location. Accessory package and material removed and stored securely.
9 Keep the doors closed and unlock all casters (if installed). HaemoBank device is able to roll on the casters.
10 Move the HaemoBank device to the final location. HaemoBank device moved to final location.
11 Ensure the HaemoBank device is level, side-to-side and front-to-back and is solid on all casters (if applicable). Lock the casters to prevent movement. HaemoBank device is level and the casters are locked.
12 Check the temperature probe container for integrity and add approximately 4 oz. (1 mL) of product simulation solution (solution is 10:1 ratio water to glycerine) to the bottle (refer to the Helmer Compartmental Access Refrigerator – iBX020 Operation Manual, Chapter 8—Temperature Probes). Temperature probe container checked and filled with appropriate solution.
13 Refer to the Helmer Compartmental Access System – iBX020 Maintenance & Service Manual, Chapter 6, for instructions to Connect External Monitoring Devices (optional). External Monitoring devices connected.
14 Connect the AC Power Cord to the HaemoBank device and the Ethernet Cable to the BloodTrack Kiosk (refer to the Helmer Compartmental Access Refrigerator – iBX020 Maintenance & Service Manual, Chapter 6.4—Connect AC Power Cord and Ethernet Cable for Kiosk). AC power cord and Ethernet cable connected.
15 Power up the HaemoBank device (refer to the Helmer Compartmental Access Refrigerator – iBX020 Operation Manual, Chapter 10—Operation). HaemoBank device is on.
16 Ensure the i.C3® control and monitoring system powers on and calibrate the touchscreen. (Refer to the Helmer Compartmental Access Refrigerator – iBX020 Operation Manual, Chapter 10—Operation.) Home screen is displayed on the i.C3 control and monitoring system.
17 Ensure compressor turns on. Compressor on.
18 Configure password on the i.C3. (Refer to the Helmer i.C3 User Guide for Compartmental Access Refrigerators, Chapter 5—Settings—Users and Passwords.) Password related setting on i.C3 is configured.

Temperature Configuration

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Obtain the following HaemoBank device temperature related set points from customer; Temperature set point (desired temperature, e.g., 4° C) Primary Probe high temp – alarm set point (high, e.g., 6° C) Primary Probe low temp – alarm set point (low, e.g., 2° C) (Note the temperature values in the Comments field.) HaemoBank device temperature related set points obtained from customer.
2 Set the Temperature set point on HaemoBank device (refer to the Helmer Compartmental Access Refrigerator – iBX020 Operation Manual, Chapter 10.4—Change Temperature Set Point). Temperature set point on HaemoBank device configured.
3 Set the Alarm Parameters; Primary Probe High Temp Primary Probe Low Temp (Refer to the Helmer i.C3 User Guide for Compartmental Access Refrigerators, Chapter 5—Settings—Alarm Settings.) If temperature monitoring is enabled, the BloodTrack Software will automatically set the Primary Probe High Temperature and Primary Probe Low Temperature to the High and Low Alarm values as configured in the BloodTrack Software. Alarm parameters on HaemoBank device configured.
4 Perform Temperature Alarm Test (refer to the Helmer i.C3 User Guide for Compartmental Access Refrigerators, Chapter 7—Temperature Alarm Test). Temperature Alarm Test passed.
5 Allow the HaemoBank device to return to operational temperature. HaemoBank device returns to operational temperature.

Attach BloodTrack Kiosk

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Attach a standalone BloodTrack Kiosk to the Helmer iBX020 refrigerator using the BloodTrack Kiosk Installation Qualification Checklist. BloodTrack Kiosk is attached and HaemoBank 20 device is ready for software-related qualification steps (see the Software section on page 8).

Software Installation and Configuration

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Within the ASK Manager Software, add and configure the appropriate Site Group (if required), Site, Location, ‘HaemoBank® Blood Storage’ device using a friendly name and the ‘BloodTrack® Kiosk’ device using the BloodTrack Kiosk name. Enter names in Comment fields. Refer to the BloodTrack Kiosk Service Manual for BloodTrack Kiosk setup information. Items created and configured within the ASK Manager Software.
2 Within BloodTrack Manager® | Configuration | Courier®, ensure a BloodTrack Courier HaemoBank Configuration Profile exists or create a new one. The correct HaemoBank Configuration Profile selected.
3 Within BloodTrack Manager | Configuration | Courier | Products, configure the HaemoBank Storage Location with appropriate blood product(s). Blood Product(s) configured for the HaemoBank Storage Location.
4 Within BloodTrack Manager | Configuration | Courier | Products, configure the HaemoBank Storage Location with appropriate Emergency Blood product(s) for each Emergency Blood Group. Emergency Blood Group(s) configured for the HaemoBank Storage Location.
5 Within BloodTrack Manager | Configuration | Courier | Kiosks, ensure a BloodTrack Courier Kiosks Profile exists or create a new one to associate the HaemoBank Kiosk to the HaemoBank Storage Location. Select the appropriate HaemoBank Door Lock Profile (HaemoBank 20), and enter the HaemoBank and BloodTrack URLs for Compartment Access and Control Access. BloodTrack Courier Kiosk Profile configured.
6 Create a BloodTrack Courier Configuration Profile Assignment for the BloodTrack Kiosk associated with the HaemoBank 20 device. BloodTrack Courier Configuration Profile assigned to the appropriate BloodTrack Kiosk.
7 Within BloodTrack Manager | Configuration | Courier | Temperature, associate the HaemoBank Temperature Probe with the HaemoBank Courier Kiosk and the HaemoBank Storage Location. HaemoBank device Temperature Monitoring set up and configured.
8 Copy or choose the appropriate label template file (with extension .PRN) to the BloodTrack Courier\Labels folder for the labels the printer will print. Appropriate PRN file selected.
9 Create the necessary Microsoft Windows users on the HaemoBank kiosk. (List user names in the Comments field.) Local administrator is created or configured. Local user is created or configured (if necessary).
10 Start the BloodTrack Courier Software on the attached BloodTrack Kiosk. The BloodTrack Courier Software starts.
11 Ensure that the profile loads correctly for the HaemoBank device, the door locks engage properly and the normal ‘Scan your Identification’ screen appears on the attached BloodTrack Kiosk. The correct HaemoBank device profile loads correctly and the ‘Scan your Identification’ screen appears with no error messages.
12 Access the BloodTrack Courier configuration screen using configuration password. The Configuration screen displays.
13 Open the Door Lock Test dialog. Press ‘Test All’ and select the ‘Tray’ test. The user is walked through opening and closing each of the trays. The blue light in each tray is lit, the user can open and close the tray and the tool moves onto the next tray until the test completes.
14 The user is prompted to test the barcode scanner. The user presses the ‘Print Barcodes’ button to print the barcodes to be scanned. On barcode scanner test, touch Cancel The barcodes are printed.
15 Exit the Door Lock Test dialog. Door Lock Test exits and the ‘Scan your Identification’ screen displays.

Login Variations

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Manual Login: Unknown User ID. User is not known to the system, access not granted.
2 Manual Login: Valid User ID. User logs in properly, access granted, software moves to the next step.
3 Barcode User ID Login: Unknown User ID. User is not known to the system, access not granted.
4 Barcode User ID Login: Valid User ID. User logs in properly, access granted, software moves to the next step.
5 User ID with password: Invalid password. Invalid password. Access not granted, user prompted to try again.
6 User ID with password: Valid password. User logs in properly, access granted, software moves to the next step.
7 Login Without ID Login. Login Without ID red icon message displays, continues to normal system functionality.
8 Emergency Access Login. Emergency Access red icon message displays, continues to 'Emergency Blood' screen.
9 Inactivity Timeout. The BloodTrack Courier Software moves to main screen, logging the user out, after the maximum inactivity time is reached.

Unit Movement—Taking Out

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Pickup Slip scan. ‘Unlocking’, ‘Remove Unit' and 'Scan Unit Number' screens display with patient demographics shown on the left. Crossmatched units may be moved out with 'GOOD' message on unit scan.
2 Search 'By Patient Number'. Confirm Patient Details' screen with appropriate details displays. Choosing 'Yes' moves to ‘Select a Product’. After selecting the product: ‘Unlocking’, 'Remove Unit' screens display. Once that the unit is removed the 'Scan Unit Number' screen displays. Crossmatched units may be moved out with 'GOOD' message on unit scan.
3 Search 'By Last Name'. Confirm Patient Details' screen with appropriate details displays. Choosing 'Yes' moves to ‘Select a Product’. After selecting the product: ‘Unlocking’, 'Remove Unit' screens display. After removing the unit the 'Scan Unit Number' screen displays. Crossmatched units may be moved out with 'GOOD' message on unit scan.
4 Visual Patient Confirmation displays all patient demographics properly. All demographic details including Hospital Number, NHS number if present, Last Name, First Name, Date of Birth and Gender are displayed properly.
5 Prompt for transportation method. Transport method appears and appropriate method is reported when chosen.
6 Autologous, directed donation and volunteer unit. Appropriate unit type is chosen.
7 Transport Method 'Cooler'—Scan cooler box ID barcode—Unknown ID. Scan is discarded and the ‘Scan Cooler Barcode’ screen persists.
8 Transport Method 'Cooler'—Scan cooler box ID barcode—Known ID. Cooler box barcode is accepted, BloodTrack moves to next step properly.
9 Transport Method 'Cooler'—Scan cooler box ID barcode—No cooler barcode. ‘Touch Here if No barcode' button pressed, BloodTrack moves to next step properly.
10 Visual Product Inspection—'Yes' Chosen. Visual product inspection Yes/No message box appears. Choosing Yes moves to next step properly.
11 Visual Product Inspection—'No' Chosen. Visual product inspection Yes/No message box appears. Choosing No stops the transaction from proceeding.
12 Batch product. Batch product may be chosen properly form the list of suitable products available for the test patient, the unit number barcode on the batch product scans properly and the green 'GOOD' message displays when the unit number is scanned properly.
13 Crossmatched unit not available. Yellow icon message appears to state units are not available, door does not unlock.
14 Expired unit. Red icon message appears.
15 Unknown unit. Red icon message appears.
16 Unit that is already out—Same transaction. Yellow icon message appears to state the unit has already been scanned.
17 Unit that is already out—New transaction. Red icon message appears.
18 Retrieve another unit? Option 'No'. User is logged out, 'Scan Your Identification' screen displays, door is locked.
19 Retrieve another unit? Option 'Yes', more units available. If another unit available: After opening the door: After removing the unit and closing the door: Prompt to scan the unit appears. Unlocking screen displays. The ‘Remove Unit’ screen displays. The ‘Scan Unit Number’ screen displays.
20 Retrieve another unit? Option 'Yes', no units available. Yellow icon message appears to state units are not available.
21 Compartment empty. The BloodTrack Software will locate another unit. A ‘Lost track of unit’ alert will be generated.

BloodTrack OnDemand —Remote Allocation

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Patient eligible for Remote Allocation for a unit available in the storage location. Choosing 'Taking Out', identifying the correct patient and scanning the available unit results in a successful transaction: transfusion tag is printed, the green icon message displays when both the transfusion tag and the unit are scanned after removing the unit.
2 Unit removed is not for the intended patient. Choosing 'Taking Out', identifying the correct patient and scanning a unit for another patient results in a red icon message stating the ‘The unit that you scanned should not have been in the compartment that it was removed from.’
3 Hazard Mitigation—Return the unit to the storage location. User is prompted to store the unit.
4 Remote Allocation—Scan wrong transfusion tag. Choosing 'Taking Out', identifying the correct patient and scanning the available unit prompts the print of the transfusion tag. The user is then prompted to scan the unit, followed by the transfusion tag. Scanning an incorrect transfusion tag results in a red icon message stating the transfusion tag is not the correct transfusion tag.
5 Hazard Mitigation—Return the unit to the storage location. User is prompted to store the unit.
6 Hazard Mitigation—Unit is stored. Warning is displayed. Red icon message appears stating the transaction did not complete properly and to call Blood Bank.
7 Unit passed its dereservation date. Units with the dereservation date that has passed cannot be removed unless their condition is updated. Choosing 'Taking Out', identifying the correct patient that is eligible for remote allocation; Yellow icon message stating there is no blood available displays.
8 Patient eligible for Remote Allocation for a unit available in the storage location, scan the correct unit. After the transfusion tag printed and when prompted to scan the unit, wrong unit scanned. Red icon message appears stating that the wrong unit was scanned.
9 Hazard Mitigation—User is prompted to scan correct unit. Red icon message appears stating that the wrong unit was scanned and to scan the correct unit.
10 Patient eligible for Remote Allocation but no unit available in the storage location. Yellow icon message appears stating the patient is eligible, but there are no suitable units at this storage location. The door does not unlock.
11 Patient not eligible for Remote Allocation, no other units available for patient. Yellow icon message appears stating the patient is not eligible and no units are available.
12 Update label count. Label count is updated as entered.
13 Maximum transport time exceeded. Red icon message appears, user prompted to put the unit in the storage location.
14 Hazard Mitigation—User is prompted to put the unit in the storage location. User is prompted to store the unit.

Unit Movement—Putting In

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Unit past its dereservation date. User prompted to put the unit in the storage location, red icon message appears.
2 Expired unit. User prompted to put the unit in the storage location, red icon message appears.
3 Known available crossmatched units. The BloodTrack Courier Software unlocks storage location and prompts for the next unit to be put in, green icon message appears
4 Units on the same donation with different product code. The BloodTrack Software requests the user scan the product code on the unit, unlocks the storage location and then displays the green icon message.
5 Unknown unit. Red icon message appears, storage location remains locked.
6 Room temperature product moved into refrigerated storage. Red icon message appears, storage location remains locked.
7 Batch product. The BloodTrack Software unlocks storage location, after storing the unit green icon message appears and then prompts for the next unit to be put in.
8 Verify transport method—Incorrect method. User prompted to put the unit in the storage location, red icon message appears.
9 Verify transport method—Correct method. The BloodTrack Software unlocks storage location, prompts for the next unit to be put in, green icon message appears.
10 After 30 minutes—Maximum transport time exceeded? User prompted to put the unit in the storage location, red icon message appears.
11 Compartment not empty. Compartment contains a unit that should not be in the HaemoBank device. A ‘Compartment Not Empty’ alert is generated.

Emergency Blood

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Emergency Blood available—Correct unit. Storage location unlocks. When user scans unit the green icon message screen appears.
2 Emergency Blood available—Incorrect unit. Storage location unlocks. When user scans incorrect unit the red icon message appears and the BloodTrack Software asks the user to return the unit to the storage location.
3 Emergency Blood available—No unit scanned. Storage location unlocks. After removing the blood and the timeout period has lapsed, the BloodTrack Software generates a ‘Removed without scanning ' alert.
4 No Emergency Blood available. Yellow icon message appears stating no units are available at this location. The storage location does not unlock.
5 Emergency Blood available—more blood—unallocated units still available The BloodTrack Software asks if another unit is required, user selects ‘Yes” and another unit is issued.

Inventory Management

Test Description Expected Result P-Pass / F-Fail / N/A Initials Actual Result (Comments)
1 Update Unit—Inside. The storage location unlocks and prompts the user to scan the unit. On scanning the unit, the details of the unit are displayed. When the unit is updated, the user is prompted to store the unit (if State is ‘In’) then the green icon message appears and the workflow moves to ask the user to scan the next unit.
2 Update Unit—Outside. The storage location does not unlock, but prompts the user to scan the unit. On scanning the unit, the details of the unit are displayed. When the unit is updated to ‘Out’ and ‘Available’, the green icon message appears and the workflow moves to ask the user to scan the next unit.
3 Bulk Move—Known available unit. On unit scan, a green icon message screen appears. The user is not to enter in or verify any patient details regarding this unit.
4 Bulk Move—Problem unit. On unit scan, a red icon message appears to notify the user there is a problem with this unit. Workflow continues as normal.
5 Bulk Move—Unknown unit. On unit and product code scan, a red icon message appears to notify the user there is a problem with this unit. Workflow continues as normal.
6 Return To Stock—Inside. The storage location unlocks and prompts the user to scan the unit. On scanning the unit, the green icon message is displayed. Workflow returns to asking the user to scan the next unit.
7 Return To Stock—Inside—Expired unit. The storage location unlocks and prompts the user to scan the unit. On scanning the unit, the red icon message is displayed. Workflow returns to asking the user to scan the next unit.
8 Return To Stock—Unit already Returned To Stock. The storage location unlocks and prompts the user to scan the unit. On scanning the unit, if the unit was returned to stock in the same transaction, the yellow icon message is displayed, informing the user the unit has already been scanned. In a separate transaction, a red icon message screen displays, informing the user the unit has already been returned to stock. Workflow returns to asking the user to scan the next unit.
9 Return To Stock—Outside—Unknown unit. The storage location does not unlock but prompts the user to scan the unit. On scanning the unit, he BloodTrack Software asks for a product code scan. On scanning the product code, the red icon message is displayed. Workflow returns to the ‘Taking Out’ screen.
10 Return To Stock—Unit that is outside. The storage location does not unlock but prompts the user to scan the unit. On scanning the unit, the green icon message is displayed. Workflow returns to the ‘Taking Out’ screen.
11 Return To Stock—Inside—Batch product—Select From List (or Compartment Number) The storage location unlocks and prompts the user to scan the unit. On scanning the unit, the green icon message is displayed. Workflow returns to the ‘Taking Out’ screen.
12 Fate Unit—Transfused. The storage location does not unlock but prompts the user to scan the unit. On scanning the unit, the green icon message is displayed. Workflow returns to asking the user to scan the next unit.
13 Fate Unit—Transfused retrospectively (at BloodTrack Manager Software PC). The user scans the unit, selects 'Transfused' and chooses the retrospective date. On completion of the last field, the green icon message is displayed. Workflow returns to the 'End Transfusion' screen.
14 Fate Unit—Unit already fated. The storage location does not unlock, but prompts the user to scan the unit. On scanning the unit, if the unit was fated in the same transaction, the yellow icon message is displayed, informing the user the unit has already been scanned. In a separate transaction, a red icon message screen displays, informing the user the unit has already been fated. Workflow returns to asking the user to scan the next unit.
15 Fate Unit—Unknown unit. The storage location does not unlock but prompts the user to scan the unit. On scanning the unit, the BloodTrack Software asks for a product code scan. On scanning the product code, the red icon message is displayed. Workflow returns to asking the user to scan the next unit.

Temperature Readings

TestDescriptionP-Pass/F-FailInitialsReadings
1 Primary Probe Temperature:
2 Temperature Set Point
3 Primary Probe High Temp
4 Primary Probe Low Temp
Installer Comments
Incident Report Reference(s), if installation failed
Attachment ReferenceDescriptionNumber of Pages
Overall Result

Customer Acceptance (Declaration of Conformity)

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