Hospira
Sapphire Infusion Pumps
Sapphire Multi-Therapy and Dedicated Infusion Pumps Addendum 3 for sw 13.22.1 Rev13 Ver 01 Dec 2018
User Manual Addendum
9 Pages
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Change to Page 2: Clause 'Warning' Update: The following sentences were added to the end of the first paragraph: Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document. Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system, may result in operation that is not within the constraints and parameters of the device. Note: The use of Administration sets manufactured by ICU Medical is approved for sale through March, 2023. Changes to Chapter 1: Introduction; Clause 'Proper Use of the Pump’; Sub-clause Administration Sets Update: The warning was replaced with the following: Use Q Core standard administration sets listed here or in Q Core's approved list of products: http://www.qcore.com/. Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document. Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system, may result in operation that is not within the constraints and parameters of the device. Severe injury or death may result from using sets other than those indicated in Q Core's approved list of products. For more information refer to Administration Sets on page 63. Note: The use of Administration sets manufactured by ICU Medical is approved for sale through March, 2023. Changes to Chapter 1: Introduction; Clause 'Basic Infusion Safety Information' Update: The following sentences were added to the first paragraph: When clamping the administration set, ensure the clamp is at least 20 cm (8 in) away from the pump, when possible.
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
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; Clause 'Proper Use of the Pump'; Sub-clause 'Administering Infusions: General Safety Precautions' Update: A bullet was added to the warnings list: Air detection o The air detector working range when delivering fatty acids is 2%-20% lipids. Changes to Chapter 2: Components, Accessories, and Administration Sets; Clause ‘Using Pump Accessories’; Sub-clause ‘Administration sets’ Update: the following information was added to the first paragraph, after the first sentence: o
Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document. Note: The use of Administration sets manufactured by ICU Medical is approved for sale through March, 2023. Changes to Chapter 2: Components, Accessories, and Administration Sets; Clause ‘Using Pump Accessories’; Sub-clause ‘Q Core Approved Administration sets’ Update: The warning was replaced with the following: Use Q Core standard administration sets listed here or in Q Core's approved list of products: http://www.qcore.com/. Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document. Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system, may result in operation that is not within the constraints and parameters of the device. Note: The use of Administration sets manufactured by ICU Medical is approved for sale through March, 2023.
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Update: The following information was added below the approved Q Core administration sets table: All filters used in Q Core approved administration sets are air eliminating filters. Changes to Chapter 3: Fundamental Concepts and Operations; Clause 'Working with the Main Display'; Sub-clause 'Alphanumeric keypad' Update: The first paragraph was updated: In some instances, for example, defining a new PreSet program or entering a drug name, the keypad displays letters and symbols in addition to numbers. Changes to Chapter 3: Fundamental Concepts and Operations; Clause 'Enabling Special Features'; Sub-clause 'A technician authorization code is required to enable/disable the following additional features' Update: The following replaces the New Patient feature in the table: Feature Delivery Mode(s) Description/Notes New Patient All Allow users to associate an infusion with a patient and reset the Accumulated VI (accumulated volume infused) Changes to Chapter 4: Getting Started; Clause 'Connecting the Infusion Container to the Administration Set' Update: The '> To connect the container to the administration set:' workflow was updated: 1. Open the sterilized administration set package. 2. Close the clamps and the AFFV to block the administration set. Ensure the clamp is located at least 20 cm (8 in) from the pump, when possible. 3. Spike the administration set into the container. Changes to Chapter 5: Using the Infusion Modes; Clause 'PCA Mode'; Sub-clause 'Infusion Parameters: PCA Mode' Update: The following replaces the Boluses per 1 h or Total dose per 1h in the table: Parameter Description Bolus per 1h (or The maximum number of boluses OR the maximum dose that can be delivered 4hrs) OR Total during a 1 hour (or 4 hours) period. (User with high authorization codes can set dose per 1hr (or the 1 hour or 4 hours parameters). The Total dose limit takes into account 4hrs) medication delivered via continuous rate, Demand bolus, Loading dose and clinician bolus. When the Total dose limit is reached, the patient is locked out from activating additional boluses. Changes to Chapter 5: Using the Infusion Modes; Clause 'PCA Mode'; Sub-clause 'PCA Mode: Midinfusion actions' Updates: P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
o o
The term Viewing Bolus History is replaced with the term Viewing Delivery History The following replaces the text in ‘To update parameters using the View/edit function key’ section, third bullet in step #5: Delivery History: Displays summary of medication delivery events. For more information, refer to Viewing Delivery History section.
Changes to Chapter 5: Using the Infusion Modes; Clause 'Epidural Mode'; Sub-clause 'Infusion Parameters: PCEA Mode' Update: The following replaces the Boluses per 1 h or Total dose per 1h in the table: Parameter Description Bolus per 1h (or The maximum number of boluses OR the maximum dose that can be delivered 4hrs) OR Total during a 1 hour (or 4 hours) period. (User with high authorization codes can set dose per 1hr (or the 1 hour or 4 hours parameters). The Total dose limit takes into account 4hrs) medication delivered via continuous rate and Demand bolus. When the Total dose limit is reached, the patient is locked out from activating additional boluses. Changes to Chapter 5: Using the Infusion Modes; Clause 'PCEA Mode'; Sub-clause 'PCEA Mode: Midinfusion actions' Updates: o o
The term Viewing Bolus History is replaced with the term Viewing Delivery History The following replaces the text in ‘To update parameters using the View/edit function key’ section, third bullet in step #5: Delivery History: Displays summary of medication delivery events. For more information, refer to Viewing Delivery History section.
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Changes to Chapter 5: Using the Infusion Modes; Clause 'Epidural Mode'; Sub-clause 'Infusion Parameters: Epidural Intermittent Mode' Update: The following replaces the Boluses per 1 h or Total dose per 1h in the table: Parameter Description Bolus per 1h (or The maximum number of boluses OR the maximum dose that can be delivered 4hrs) OR Total during a 1 hour (or 4 hours) period. (User with high authorization codes can set dose per 1hr (or the 1 hour or 4 hours parameters). The Total dose limit takes into account 4hrs)* medication delivered via continuous rate, intermittent doses and Demand bolus. When the Total dose limit is reached, the patient is locked out from activating additional boluses. Changes to Chapter 5: Using the Infusion Modes; Clause 'Epidural Mode'; Sub-clause 'Epidural Intermittent Mode: Mid-infusion Actions' Updates: The term Viewing Bolus History is replaced with the term Viewing Delivery History The following replaces the text in ‘To update parameters using the View/edit function key’ section, third bullet in step #5: Delivery History: Displays summary of medication delivery events. For more information, refer to Viewing Delivery History section. o The following replaces the first paragraph in ‘Administering a Clinician Bolus’ section A bolus of any amount (within the predefined range) can be delivered by clinicians who have a High authorization level code. A clinician bolus can be given only while the infusion is running. The lockout time is reset after delivering a clinician bolus. Clinician bolus is applicable only when programming Epidural Intermittent with PCEA.
o o
Changes to Chapter 6: Basic Infusion Operations; Clause Starting New Infusions: Shortcuts; Subclause: Repeating last infusion Updates: o
The first note was replaced with the following note: When using Repeat Last Infusion option, the Delivery History, Accumulated VI parameter and the remaining Lockout Time are not cleared; instead, they continue counting from the previous infusion. For more information about Accumulated VI and Delivery History, refer to Using the New Patient feature chapter.
Changes to Chapter 6: Basic Infusion Operations; Clause 'Resuming Infusions After Pump Shutdown' Update: 'To resume the infusion' section was updated To resume the infusion: o On the Attention screen, press OK. o The Paused infusion screen appears, press Request continue to resume the infusion. P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
o On the attention screen press OK to confirm. o The running screen appears. Changes to Chapter 7: Options Menu: Configuring, Viewing and Testing ; Clause 'Main Options: Overview' Update: The last sentence in the overview was replaced with the following sentence: The screen also provides access to testing components and viewing pump (as opposed to infusion) parameters (e.g. System parameters, Event logs, and Delivery History). Changes to Chapter 7: Options Menu: Configuring, Viewing and Testing; Clause 'Managing Configuration Settings'; Sub-clause 'View Menu' Update: The bolus history category in the table was replaced with the following: Category Description/Notes Delivery History (PCA, Provides a view of the boluses and the total amount of medication PCEA and Epidural delivered during PCA, PCEA or PIEB infusion. The Delivery History is intermittent delivery associated with a patient. For more information, refer to Viewing modes only) Delivery History section. Changes to Chapter 7: Options Menu: Configuring, Viewing and Testing; Clause 'Managing Configuration settings'; Sub-clause 'Managing Alarm Settings' Update: In the description of ‘Infusion near end’ option the note has been removed. Changes to Chapter 7: Options Menu: Configuring, Viewing and Testing; Clause 'Viewing Bolus History' Update: Title and first paragraph were replaced with the following: Viewing Delivery History This screen, which appears only in PCA, PCEA and PIEB delivery modes, provides a summary of all bolus-related events that occurred during a specified time frame and the total amount of medication delivered throughout the treatment. Note: To access the Delivery History during PCA, PIEB or PCEA infusions: From the toolbar select View/edit, then, select Edit PCEA --> Delivery History. When the pump is locked, the Delivery History can be accessed from the toolbar without unlocking the pump. Delivery History information includes:
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
Page 6 of 9
USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Update: The Bolus History information table was updated: 1. Total Dose given parameter was added 2. History period parameter was replaced with the text below Name of Value Description/Notes Total Dose given The total amount of drug delivered to the patient during a treatment through Boluses, Loading dose, Continuous rate, KVO if applied and Intermittent doses. When using Repeat Last Infusion, this value accumulates from the previous infusion/s. Bolus History Period The number of hours over which the displayed boluses occurred. The default history period is 1 hour, and it can be set from 1 hour up to the number of hours that the infusion has been running. The setting can be modified by pressing >, entering a value using the keypad, and then pressing OK. 3. The note below the table was replaced with the following note When using the Repeat Last Infusion option (for the same patient), the Delivery History, accumulated VI and lockout time are not cleared, they continue counting from the previous infusion. Changes to Chapter 8: Using Advanced Features; Clause 'Using the New Patient Feature' Update: The entire clause was replaced with the following: When the New Patient feature is enabled, and either a New Infusion or a PreSet program is selected, the pump will prompt you to indicate whether the infusion to be programmed is for a new patient or not. When selecting Repeat Last Infusion the New Patient screen will not appear, and the pump will indicate that the infusion to be repeated will be used for the last patient selected. Note: The New Patient feature can be enabled/ disabled by technicians only. When a New Patient is selected, entries associated with the patient can be tracked in the Event Log (Viewing the Event Log section). In addition, when Repeat Last Infusion is used the pump calculates the accumulated volume infused (Accumulated VI) for all infusions associated with the patient, and the Delivery History. When a new patient is selected, the Accumulated VI and Delivery History are automatically cleared (for more information, refer to Monitoring the Accumulated Volume Infused (Shift's Total) section). The current accumulated Delivery history can be viewed via the Options menu. When an infusion is running, the Delivery History can be accessed via the View/Edit soft key in the toolbar (for more information, refer to the Viewing Delivery History section). To select a new patient: 1. From the startup screen, select New Infusion or PreSet Programs 2. On the New Patient screen, select Yes.
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
Page 7 of 9
USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Changes to Chapter 10: Alarms and Troubleshooting; Clause 'Level 3 Alarms' Update: Additional Alarms were added to the table. Alarm Title Displayed Text Potential Air in Line Press OK to test for air Pump Stopped Please quit and then restart the infusion Changes to Chapter 11: Maintenance and Storage; Clause 'Preventive Maintenance'; Sub-clause 'Cleaning and Disinfecting the Pump' Update: Cleaning and Disinfection: Safety Precautions
A safety precaution was added to the list: Do not clean the pump with Bleach (8.25% concentration, mixed at 1 part bleach in 10 parts water), as deterioration may occur. The precaution note was replaced with the following precaution 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).
Update: Cleaning and Disinfection Procedure - one cleaning agent was added to the table: Cleaning/Disinfecting Solution Virox® AHP 5 RTU
Manufacturer Diversey
Changes to Chapter 11: Maintenance and Storage; Clause: ‘Preventive Maintenance’; Sub-clause: Alarm Testing’ Update: The first paragraph was replaced with the following: It is recommended to perform manual testing of the following alarms at least once a year. Alarm testing can be conducted as part of the yearly certification. For the Sapphire Epidural pump manual alarm testing, refer to the testing protocols available for authorized technicians (for more information refer to the service manual). Changes to Chapter 11: Maintenance and Storage; Clause 'Preventive Maintenance'; Sub-clause 'Battery Care Information' Update: The first 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, on the upper right corner of the indicators bar, indicates remaining battery capacity. Check the status of the battery charge level icon regularly: P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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USER MANUAL SAPPHIRE MULTI-THERAPY AND DEDICATED INFUSION PUMPS - ADDENDUM 3 15025-048-0044 * (Rev 13 Ver01), Update to Sapphire SW 13.22.1 and clarification regarding administration sets of different manufacturers *P/N 15025-048-0044 refers to User Manual for Sapphire Rev 13 Ver01 – English
Changes to Chapter 13: Limited Warranty; Clause 'Service Information' Update: The following sentence was added to the paragraph: The Sapphire pump service life is 7 years from the date of manufacture.
P/N 15025-048-0072-UM-02/12.2018
Q Core Medical Proprietary
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