Addendum
41 Pages
Preview
Page 1
SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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: Warnings and Safety Precautions, Proper Use of the Pump, Basic Infusion Safety Information Update: 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. 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.
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 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: 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 1: 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's official approved list of materials (published at www.qcore.com) Changes to Chapter 3: Maintenance and Storage; Section: Preventative Maintenance, Alarm Testing Update: New instructions regarding Sapphire Epidural pumps
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 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). These Testing Protocols can be found on Q Core FTP site (https://qcore.smartfile.com/). For information regarding the FTP site, refer to the FTP site on page 28 of the Service Manual. 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, please contact [email protected] or the local Hospira 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.
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
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 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 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.
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 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
Station status
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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, 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. 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 will be displayed on the Kit Selection screen The battery information will include:
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. A new tool tip was added with this information. 15025-048-0057-SM-12
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 event
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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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-12
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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
Q Core Medical Proprietary
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, 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 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. Changes to Chapter 6: Replacing the Battery Update 1: Instructions on how to report on battery replacement on the Q core 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 Service Portal: 15025-048-0057-SM-12
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 1. 2. 3. 4.
Go to https://service.qcore.com/ Login using your credentials In the Service Portal Home Page click Battery Replacement 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 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 Service Portal.
Update 3: New battery cover The new battery cover includes an over-mold seal instead of the previous O-ring seal. For pumps with the O-ring seal on the battery cover, verify that the O-ring cannot be seen after closing the battery cover. For pumps with the over-mold seal on the battery cover, verify that the over-mold is not pinched and not seen after closing the battery cover. Current Battery Cover
New Battery Cover
Current and New Battery Covers
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Changes to Chapter 7: Sapphire & SapphireH100; Section: Configuring Basic Pump Settings, Managing Alarm Settings Update 1: The Occlusion pressure option was updated in SapphireH100, software 13.22.3 The Occlusion pressure option name was changed to Occlusion Alarm. The Occlusion Alarm option is described in the table below: Option
Descriptions/Notes
Occlusion Alarm
The minimum downstream pressure that triggers an Occlusion alarm. Acceptable ranges are 1.5 to17.4 PSI, 0.1 to 1.2 BAR or 75 to 900 mmHg. An alarm sounds when the downstream pressure reaches the set value ± the sensor sensitivity level. During infusion, the current downstream pressure is displayed on the Pressure display screen (for more information refer to the SapphireH100 User Manual) and on the screen saver. Update 2: Infusion near end alarm description changed
To Modify Parameter (from the Alarms screen) Select Occlusion Alarm. Then, using the keypad, enter the desired value and press OK.
In the option Infusion near end, the note in the Descriptions/Notes column was removed. Changes to Chapter 7: Sapphire & SapphireH100; Section: Configuring Basic Pump Settings, Configuring General Settings Note: All updates in chapter 7 are relevant for Sapphire only (and not for SapphireH100) unless stated otherwise Update 1: A new menu under Pump Configuration named Audio settings was added The Audio settings menu includes the following settings: Setting
Description
Default Value
Keys Volume
Sets the speaker volume for the auditory signal generated when the user selects functions and presses keys on the pump.
High
Alarm Volume
Sets the speaker volume for the auditory alarm signal. Options are Maximum or Minimum. When the option is set to Minimum, messages are provided with a visual signal only. Alarm
Maximum
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Setting
Description
Default Value
levels 1, 2 and 3, and the “Infusion Complete” message are provided with a visual signal and the lowest auditory signal permitted according to IEC 60601-1-8. Maximum alarm volume is 70 dB. Minimum alarm volume is 56 dB. Note: Auditory alarm signal sound levels which are less than ambient levels can impede operator recognition of alarm conditions. Bolus Handle
Sets the Bolus auditory signal generated when the bolus handle is pressed. When the option is set to Always On, an auditory signal is generated each time the bolus handle is pressed. When set to When Bolusing, an auditory signal is generated upon pressing of the bolus handle only when bolus is available.
On
Update 2: The General settings menu was updated The General settings menu includes the following settings. To save changes press Next and then OK. Setting
Description
To Modify Parameter (from the General settings screen)
Current CCA
Used to select the CCA to which the pump should be set. Appears only when a Drug Library is loaded.
Start Up Config.
Set the configuration of the Start Up screen. Includes Repeat Last Infusion and PreProgram options. When the Repeat Last Infusion option is enabled, the Repeat Last Infusion frame appears on the Start Up screen. Sets the authorization lock level of the pump.
Select Current CCA. Choose the appropriate CCA; then, from the Attention screen press OK. See the User Manual
Authorization level
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Select Authorization level. Then, enter a Page 19 of 41
SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 13 Updated to Sapphire SW 13.21.1 and SW 13.22.1, SapphireH100 SW 13.22.3, SapphirePlus SW 14.00.0 Setting
Allow delayed start
Set Prime Volume
Backlight
Prime Reminder
Advanced Bolus
Bolus Reminder
Auto. P. Lockout
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Description
Enables/disables programming of infusions that begin after a predefined period of time (or after standby). When the option is enabled, the Set Delay frame appears on the Start screen. The amount of fluid used to prime the administration set when automatic priming is performed. The acceptable range is 2 to 25 mL. If a value outside the permitted range is entered during programming, the OK function key is disabled. Sets the degree of screen dimming while the pump is running. The Off and Partial options of this feature save power and promote longer battery life. Enables a reminder for the user to prime the administration set before starting an infusion. Allows users to program a bolus by entering rate, amount and time. When this option is disabled, the bolus is programmed by amount only, and the rate is the default bolus rate. The option is available only when Allow Bolus is enabled (under Technician options). Applicable only for the Continuous delivery mode. Enables a reminder for the user to connect the bolus handle before starting a PCA, PCEA or PIEB infusion that includes patient boluses. The reminder: • Instructs to connect the bolus handle directly to the pump. • Checks functionality – bolus press is recognized by the pump. Enables/disables Patient Lockout, a safety feature that requires password entry to make any parameter changes. When Q Core Medical Proprietary
To Modify Parameter (from the General settings screen) password and select Low, Medium, High or Tech. Select the Allow delayed start row, to toggle the option between On and Off. Select Set prime volume. Then, using the keypad, enter the desired value and press OK.
Select Backlight. Then, select On, Off or Partial.
Select the Prime Reminder row, to toggle the option between On and Off. Select the Advanced Bolus row, to toggle the option between On and Off.
Select the Bolus Reminder row, to toggle the option between On and Off.
Select the Auto P. Lockout row, to toggle the option between On Page 20 of 41