Service Manual Addendum
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Page 1
SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 1: Introduction; Section: Manual Outline and Conventions Update 1: Clarification regarding the Service Manual and its Addendum Q Core Medical is not responsible for any action performed by users that is not described in the Service Manual or in its Addendum. Changes to Chapter 1: Introduction; Section: Compliance and Classification Update: An additional standard was added to the Compliance and Classification section IEC 60601-1-12 - Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. Changes to Chapter 1: Introduction; Section: Warnings and Safety Precautions, General Warnings and Precautions, Electromagnetic Compatibility Update: the Electromagnetic Compatibility sub-clause has been rephrased The Sapphire pump is designed to conform with electromagnetic compatibility (EMC) standard IEC 60601-1-2 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard. To avoid electromagnetic interference that may affect the operation of the pump, do not use the pump near sources of strong electric and magnetic interference (EMI), such as MRI, CT, diathermy (deep heat treatment), electromagnetic security systems (e.g metal detectors) and large electric motors. Portable and mobile RF communications equipment, such as RF emitters, cellular telephones, 2-way radios, Bluetooth™ devices, microwave ovens in close proximity to this device may affect wireless communications with the Infusion pump and/or the operation of the Infusion pump. Some of these EMI sources (mostly RF emitters) may not be visible and the device can potentially be exposed to fields from these EMI sources without the user’s awareness. Special precautions need to be exercised regarding EMC. These include: •Maintaining a minimum separation distance of 2 ½ ft (¾ m) between the Infusion pump system and portable/mobile RF communications equipment • Manage the electromagnetic environment to permit the device to perform as intended without disturbing other equipment.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 • Separate the device from all other electronic equipment. If the device must be used near other electrical equipment, monitor the equipment to ensure there is no electromagnetic interference. • Devices should not be used adjacent to or stacked with other equipment. If the device must be used adjacent to or stacked with other equipment, monitor the device to verify normal operation. • If you identify or suspect external RF sources or other equipment are influencing device operation (from known or unknown source), try to (as applicable) increase the pump’s distance from the EMI source, re-orient the device, relocate the device, connecting device to different outlet, contact the biomedical engineering department for additional guidelines concerning electromagnetic immunity or decrease emitting device output power (to 30 dBm). • Contact the biomedical engineering department for additional information in the service manual concerning operating devices near RF sources. The EMC limits for the Medical Device Directive 93/42/EEC (EN301489-1/-17 IEC/EN 60601-1-2:2007) are designed to provide reasonable protection against harmful interference in a typical medical installation. The 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 other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference with other devices, 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 device • Increase the distance separating between the equipment parts • Connect the equipment to an outlet on a circuit different from that to which the other device(s) is connected • Consult the manufacturer or field service technician for help
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 1: Introduction; Section: Warnings and Safety Precautions, Proper Use of the Pump, Basic Infusion Safety Information Update 1: New instruction for clamping the administration set The first two paragraphs were replaced with the following: To obtain maximum accuracy of the pump when used in a hospital or clinical environment, verify that the infusion container is positioned at a height of 50 cm above the pump. There is no restriction on the location of the infusion container in relation to the patient’s heart. Alarm conditions automatically stop the infusion and require immediate attention before the infusion can be restarted. When clamping the administration set, ensure the clamp is at least 20 cm (8 in) away from the pump, when possible. Note that if the dose rate is beyond the pump resolution of 0.1mL/h increments, the pump will increase or decrease the rate by up to 0.05mL/h. This flow rate (mL/h) is presented on the running screen during infusion.
Update 2: four bullets were added to the Administering Infusions: General Safety Precautions warning note Air detection (Sapphire software 13.22.2): o Air detection is an important safety feature of the Sapphire pump. If the air detection is disabled (Off), use a set with an air-eliminating filter to prevent injury to the patient due to an air embolus. o Air detection serves as a safety component. Disabling the air detection hinders the pump's ability to alert on hazardous situations. o Always ensure that the administration set is primed before starting an infusion. o The air detector working range when delivering fatty acids is 2%-20% lipids.
Changes to Chapter 1: Introduction; Section: Warnings and Safety Precautions, Default Configuration Settings of the Sapphire Pump Update 1: Continuous Bolus Rate Default value was changed to 125 ml/h Update 2: PCA/PCEA Max Bolus per feature name was changed to Limit Period
The feature is accessible to High authorization level and above. The feature is available only on PCA/PCEA/Epi. Int Options menu.
Changes to Chapter 2: Managing Authorization Levels; Section: Overview Update: Note regarding the pump passwords was added The following note was added at the end of the section: 15025-048-0057-SM-13
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 It is recommended to change the authorization level passwords from the factory defaults, to avoid unauthorized users from accessing the pump. To change a password see page 139 in the Service Manual. Changes to Chapter 3: Maintenance and Storage; Section: Cleaning and Disinfection: Safety Precautions Update: Additional bullet was added to the list of safety precaution guidelines Do not clean the pump with bleach (8.25% concentration, mixed at 1 part bleach in 10 parts water), as deterioration may occur. Changes to Chapter 3: Maintenance and Storage; Section: Cleaning and Disinfecting Procedure Update: One cleaning agent was added to the table Cleaning/Disinfecting Solution
Manufacturer
Virox® AHP 5 RTU
Diversey
Changes to Chapter 3: Maintenance and Storage; Section: Cleaning and Disinfecting Procedure Update: The caution note was replaced The caution note was replaced with the following caution note: Before using materials other than the products listed above for cleaning and disinfecting the Sapphire Infusion pump, make sure they are listed in Q Core Medical’s official approved list of materials (published at www.qcore.com ) Changes to Chapter 3: Maintenance and Storage; Section: Preventative Maintenance, Alarm Testing Update 1: New instructions regarding Sapphire Epidural pumps To perform the manual testing of the Air in Line alarm and Occlusion alarm in Sapphire Epidural pumps refer to the 'Field Air Detector Test for Sapphire, SapphireH100 and SapphirePlus Infusion Pumps' (P/N 15025-042-0057) and 'Field Occlusion Test for Sapphire SapphireH100 and SapphirePlus Infusion Pumps' (P/N 15020-042-0006). The Testing Protocols can be found on the Q Core Medical Service Portal, https://service.qcore.com/ 15025-048-0057-SM-13
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Update 2: A note was added to the Air in Line test Note – in Sapphire software 13.22.2, to test the Air in Line alarm, ensure the air detection is enabled (On) in the technician options. If the air detection disabled (Off) icon is displayed and a warning message stating the air detection is disabled (Off) appears when programing an infusion, the Air in Line alarm will not be triggered. Changes to Chapter 3: Maintenance and Storage; Section: Preventative Maintenance, Built-in Test Update: Updated instructions regarding failure resolution The table on page 49 of the Service Manual is outdated and should no longer be used. For any failure in the built-in test, contact Q Core Medical via the Service Portal or contact the local distributor service center. Changes to Chapter 3: Maintenance and Storage; Section: Battery Care Information Update: Clarification regarding pump operation on battery power The paragraph preceding the table was replaced with the following: The Sapphire pump can operate on battery power, enabling operation of the pump during an electrical power failure, during patient transport or during ambulatory care. When working on battery power (disconnected from main power supply) the battery charge level icon, at the upper right corner of the indicators bar, indicates remaining battery capacity. Check the status of the battery charge level icon regularly.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 4, Performing the Annual Certification Test; section: Certification due date counting Update: Certification due date counting method for Sapphire was updated The certification due date counting method for Sapphire was updated. The certification due date counting method in software revision 13.2 is the same as in SapphirePlus software: The condition for determining the start date when counting the certification due date is the shorter of the two following options: 10 working hours 2 years from the date of the pump shipment from Q Core Medical’s warehouse When either of the above conditions is met, the next certification date is a dynamic value that will be calculated according to calibration days left from current date (calibration days = certification date + 380 – current date): 10 hours condition: Certification date is set to the date the 10 working hours were completed 2 years condition: Certification date is set to the original certification date + 2 years Before the above conditions are met, the calibration days will be calculated as follows: Certification date + 2 years + 380 days – current date. The next certification date in the View System menu will be calculated according to the calibration days that were left from the current date. After preforming the certification process, the next certification due date is set to the date of the computer that performed the test. The tolerance is +-7 days. The counting method of the due date for certification of SapphireH100 has not been changed.
Changes to Chapter 4, Performing the Annual Certification Test; Section: Annual Certification Software, Requirements Update 1: Required Operating System: Windows 7 / Windows 8 / Windows XP Update 2: New software requirement: .Net framework 4.0 Update 3: The ACK setup file is a “.msi” file; installation is required 15025-048-0057-SM-13
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 ACK software installation process: 1. Download the setup file ACK Setup (.msi file) from the Q Core Medical FTP site to a directory of your choice. 2. Double-click the ACK Setup file to start the installation process and click Next. 3. Review the license agreement details and check the relevant checkbox to accept. 4. To create a shortcut to the ACK software check/uncheck the relevant checkbox, as desired. 5. Click Install. 6. After the installation is completed click Finish.
Changes to Chapter 4, Performing the Annual Certification Test; Section: Annual Certification Software, Working with the Station Pane Update: An indication – Connected – was added to a station’s status Each station in the navigation pane corresponds to a pump (see figure below).
Stations that are not configured are disabled and appear in gray
Stations that are configured but have no pump connected to them appear in blue
Stations that are configured and have a pump connected to them appear in blue with the icon “Connected” next to them
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Station status
Changes to Chapter 4, Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Getting Started, To perform the Setup Sequence Update: The setup sequence was updated Perform the following setup: Set pump authorization level to High. Select Options->Pump configuration-> General settings->Authorization level and select High. Press Next and then OK. For Sapphire pumps, software version 13.22.2 only:
If the Air Detection disabled icon, , appears on the indicators bar, enable the Air Detection (On). Select: Options->Technician options->Pump settings->Set air detector->Air Detection. Toggle the setting to On and press OK.
Set pump authorization level to High.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
No other steps are required as part of the setup. After clicking a station to start the test, if the pump is not set to High Authorization level a message stating to set the pump to High Authorization level will appear on screen. (In case the Drug Library needs to be removed it will be indicated on the screen; see next section) Changes to Chapter 4: Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Getting Started, To perform the Preliminary Inspections Update 1: Bolus Handle test was added to the Preliminary Inspections. Sapphire Plus devices do not have the option for Patient Bolus, therefore, if a bolus handle is not available for this test, mark Pass and proceed. Update 2: Bolus handle test When using an SC bolus handle (bolus handle with a grey button), test the bolus handle prior to connecting the pump to the computer. Update 3: Drug Library removal process for pumps with software revision 11 was added The following flow is relevant only for pumps with software revision 11 and installed Drug Library: 1. Select a connected station to start the ACK process 2. For pumps with software revision 11 and installed Drug Library, a message prompted on the computer screen requiring the removal of the Drug Library will appear at the beginning of the Preliminary Inspections stage (see figure below). The message will appear after the Synchronizing message has disappeared. The prompted message is not associated with a specific station.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Drug Library removal message - 1
Press Next to approve the removal of the Drug Library and continue the ACK process. If Cancel is selected the ACK process is aborted. 3. Perform the preliminary inspections and press Next. 4. A message with details about the process will be prompted (see figure below).
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Drug Library removal message - 2
Press Next to proceed or Cancel to abort the process. The Drug Library will be temporarily removed from the pump and may be reinstalled after the ACK is completed. 5. The Drug Library removal screen will appear (see figure below). Do not use the pump before the Drug Library removal is completed and the pump has restarted. The Drug Library installation option will be available on the pump screen once the certification is completed. Note: Do not use the pump before the Drug Library removal is completed and the pump has restarted.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Remove Drug Library Screen
6. Press Next to proceed to the Kit Selection screen. Proceed according to the regular ACK flow, as described in chapter 4 of the Service Manual. 7. In the final screen (the results screen) press Close. A message regarding Drug Library upload will be prompted on the pump screen. Select the desired option.
Changes to Chapter 4: Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Getting Started, To perform the Kit Selection Update: Battery information is displayed on the Kit Selection screen The battery information includes:
Battery expiry date Charge cycles displayed as “x / 500”
One charging cycle is defined as the cycle of the battery charging from depletion to full charge. Partial cycle is defined as the fraction of a full cycle.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Battery information on the Kit selection screen
Changes to Chapter 4: Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Performing the Occlusion Sensor Test Update: Step 5 was updated Step 5 in the Occlusion Sensor test was replaced with the following: Attach the extension set to the administration set, with the check valve at the free end (Figure 4.2 on page 72 of the Service Manual); then, fill the syringe with air, and connect it to the check valve at the free end of the extension set.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 4: Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Performing the Air Detector Test Update: Steps 1 and 2 in the Air Detector Test were updated Step 1 in the Air Detector Test was replaced with the following: Remove the syringe from the extension set and then remove the extension set from the administration set. Step 2 in the Air Detector Test was replaced with the following: Connect the syringe to the Y-connector (Figure 4.1 on page 72). Using the syringe, insert 1 mL of air into the administration set, via the Y-connector and disconnect the syringe. Then, on the pump, press Start. Infusion of fluid starts, and then (when the air is recognized) stops. Changes to Chapter 4, Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, Viewing Results Update 1: The certification provided at the end of the ACK test was updated The certification includes the following information:
The field Device SW version displays the pump software version
The Occlusion sensor test and Accuracy test results are displayed on scales
The Occlusion sensor test result is displayed on a scale in Bar units. An arrow and a number below it indicate the result. Any result within the limits is defined as “Pass” (see figure below).
The Accuracy test result is displayed on a scale in percentage. An arrow and a number below it indicate the result. Any result within the limits is defined as “Pass” (see figure below).
The certification can be printed or saved on the computer in soft copy (see icons on the top right corner in the figure below). When pressing the save icon, wait for the dialog box to appear and select the desired destination of the saved file.
Note: the Next certification date in the pump’s View system menu will be updated after the pump has been operated for one second (i.e one second of treatment or of priming). 15025-048-0057-SM-13
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
Results screen
Update 2: If the ACK test fails, the reason for failure will appear on the computer screen In case of failure in the Preliminary Inspections, the reason(s) for the failure will be either one (or both) of the following (see figure below):
Visual inspection Functional inspection
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
ACK failed in the Preliminary Inspections
In case of failure in the calibration verification tests, the reason(s) for the failure will be one (or more) of the following (see figure below):
Occlusion Sensor Air Detector Flow Accuracy
Only the results of failed tests will be displayed. If the Occlusion sensor test or the Accuracy test fails, the arrow and the number below it will be displayed outside the scale, on the relevant side of it (see figure below).
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0
ACK failed in the calibration verification
Changes to Chapter 4, Performing the Annual Certification Test; Section: Performing the Annual Certification Tests, After the Test Update: The last paragraph was updated You are not required to set the pump to factory defaults after completion of the ACT. Pump configuration settings are maintained following the completion of the ACT. In case the ACT has terminated unexpectedly, the following pump parameters may change:
KVO in Continuous delivery mode Set Prime Volume Accumulated Air detector
In the event that the ACT terminates unexpectedly, we recommend that you set the pump to factory defaults.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 4, Performing the Annual Certification Test; Section: Troubleshooting Certification Testing Update 1: Three new troubleshooting cases were added Problem
Solution
During the ACK installation the following message is prompted: “This application requires .NET Framework 4.0 full, please install the .NET Framework and then run the installer again.”
o o o o o
During the ACK installation the following message is prompted: “This application is supported on Windows XP, Windows 7 and higher." The next certification due date, as it appears in the certification provided at the end of the ACK, is different than the next certification due date in the View system menu on the pump.
o
o o
o
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Click OK to cancel the installation On the computer: Go to Start->All Programs >Windows Update Select Optional Updates and then select .NET Framework 4.0. Follow the online instructions to complete the update Double-click the ACK Setup file to start the installation again Use a computer with the appropriate operating system
The next certification due date as it appears in the certification is correct The next certification due date in the View system menu will be updated with the date as it appears in the certification, after the pump has operated for one second There may be a difference of one day between the next certification due date in the certification and in the View system menu
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Update 2: Two new messages were added The ACK will prompt a message in the following cases: Case
Message Displayed
Solution
Unauthorized pump software version
The software version installed on this pump is obsolete! Please update the software to an authorized version before proceeding with the process. Authorized software versions are available for download from Q Core FTP site at https://qcore.smartfile.com/. A valid username and password is required to access the website.
Update the pump software to an approved version before proceeding. Approved pump software versions are available for download on the Q Core Medical FTP site at https://qcore.smartfile.com/. Valid username and password are required in order to access the website.
Obsolete ACK software version
The ACK software version you are using is out of date. A new version of the ACK software is available for download from Q Core FTP site at https://qcore.smartfile.com/. A valid username and password is required to access the website.
Install the most updated ACK software
Changes to Chapter 5: Downloading Event Log Update: Chapter removed The chapter Downloading Event Log has been removed. The Events Viewer software and its DFU (Directions for Use, 16008-003-0001) can be obtained from Q Core Medical FTP site (https://qcore.smartfile.com/). The DFU includes the list of all pump events.
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SERVICE MANUAL LEVEL 1 – ADDENDUM 14 Updated to Sapphire SW 13.21.1, SW 13.22.1, SW 13.22.2 SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 6: Replacing the Battery Update 1: Instructions on how to report on battery replacement on the Q core Medical Service Portal were added, the Caution note on page 120 was updated. The Caution note was replaced with the following: Reporting on battery replacement in the Q Core Medical Service Portal: 1. Go to https://service.qcore.com/ 2. Login using your credentials 3. In the Service Portal Home Page click Battery Replacement 4. Fill in the details of the device and the replaced battery. Proceed to the Battery Replacement Report and Checkout. For more information on the Q Core Medical Service Portal refer to Service Portal Work Instructions, 16019-049-0001-SRV. Update 2: Step 5 in the battery replacement flow was updated Updated step 5: Set the old battery aside, record the new battery’s serial number prior to installing it in the device. Record the battery’s serial number in the Q Core Medical Service Portal.
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