Service Manual Addendum
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 1: Introduction, 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 at PCA/PCEA/Epi. Int Options menu.
Changes in Chapter 4: Annual Certification Overview, 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 for Sapphire with software revision 13.2 is as for SapphirePlus: The starting condition for counting the certification date is the shorter of the two options: 10 working hours 2 years from pump’s shipment day from Q Core Medical’s warehouse (set in the EEPROM as the certification date during Q Core Medical’s FTP lab process) After 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 in the EEPROM is set to the date of the PC that performed the test. The tolerance is +-7 days. The certification due date counting method for SapphireH100 hasn’t changed. 15025-048-0057-SM-01
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 4: Performing the Annual Certification Tests, Getting started Update: Clarification regarding the treatment needed to be programmed prior to performing the ACT Program a treatment prior to performing the ACT according to the following table. The described below substitutes step 3 in the section To Perform the Setup Sequence, as it appears on pages 8284 of the Service Manual. Note: Steps 1 and 2 in the section To perform the Setup Sequence on page 82 of the Service Manual haven’t changed. Pump Type Sapphire Multi-Therapy
Software Revision Revision 9
With/Without Drug Library Not applicable
Remove Drug Library prior to ACT Not applicable
Revision 11
With
No
Without
Not applicable
With
No
Without
Not applicable
Revision 13
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Treatment to Program a. Select Continuous delivery mode b. Configure treatment: Rate=100ml/h, VTBI=100ml c. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure a treatment with Drug Name=”General” c. Configure treatment: Rate=100ml/h, VTBI=100ml d. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure treatment: Rate=100ml/h, VTBI=100ml c. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure a treatment with Drug Name=”General” c. Configure treatment: Rate=100ml/h, VTBI=100ml d. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure treatment: Rate=100ml/h, VTBI=100ml c. Proceed to steps 1-4 described on page 4 below Page 2 of 14
SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Pump Type
Software Revision
With/Without Drug Library
Remove Drug Library prior to ACT
Sapphire Epidural
Revision 9
Not applicable
Not applicable
Revision 11
With
Yes
Without
Not applicable
With
No
Without
Not applicable
Revision 13
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Treatment to Program a. Select PCEA delivery mode b. Configure treatment: VTBI=100 ml, Continuous Rate=10 ml/h, Demand bolus=0mL, No loading Dose c. Proceed to steps 1-4 described on page 4 below a. Select PCEA delivery mode b. Configure treatment: VTBI=100 ml, Continuous Rate=10 ml/h, Demand bolus=0mL, No loading Dose c. Proceed to steps 1-4 described on page 4 below a. Select PCEA delivery mode b. Configure treatment: VTBI=100 ml, Continuous Rate=10 ml/h, Demand bolus=0mL, No loading Dose c. Proceed to steps 1-4 described on page 4 below a. Select PCEA delivery mode b. Configure a treatment with Drug Name=”General” c. Configure treatment: VTBI=100 ml, Continuous Rate=10 ml/h, Demand bolus=0mL, No loading Dose d. Proceed to steps 1-4 described on page 4 below a. Select PCEA delivery mode b. Configure treatment: VTBI=100 ml, Continuous Rate=10 ml/h, Demand bolus=0mL, No loading Dose c. Proceed to steps 1-4 described on page 4 below
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Pump Type
Software Revision
With/Without Drug Library
Remove Drug Library prior to ACT
SapphireH100
All
With
No
Without
Not applicable
With
No
Without
Not applicable
SapphirePlus
All
Treatment to Program
a. Select Continuous delivery mode b. Configure a treatment with Drug Name=”General” c. Configure treatment: Rate=100ml/h, VTBI=100ml d. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure treatment: Rate=100ml/h, VTBI=100ml c. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure a treatment with Drug Name=”General” c. Configure treatment: Rate=100ml/h, VTBI=100ml d. Proceed to steps 1-4 described on page 4 below a. Select Continuous delivery mode b. Configure treatment: Rate=100ml/h, VTBI=100ml c. Proceed to steps 1-4 described on page 4 below
1.
In the Confirm screen confirm treatment by pressing OK.
2.
In the Start screen exit the treatment by pressing Exit.
3.
Verify that the option Repeat Last Infusion is available (don’t select it). If not, repeat steps 1-3.
4.
Proceed to the section To Perform the Preliminary Inspections on page 85 of the Service Manual.
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 5: Downloading Event Log; -----------------------------------------------------------------------------------------------------------------------------Note: The Event Log SW was upgraded. The Upgraded SW and the DFU (Directions of Use) can be obtained from Q Core FTP site (https://qcore.smartfile.com). For the updated Event Log Viewer DFU (Directions of Use) please refer to: Using the Event Viewer software to download Event Log from the Sapphire Infusion Pump 16008003-0001 Rev.01 -----------------------------------------------------------------------------------------------------------------------------Update: New events/ text changes Event Code
Text on Screen
Comments
97
Number of Boluses per x h(s) set to: xxx (x = 1 or 4) Limit Period set to: x h(s) (x = 1 or 4) Pump unattended during paused state Bolus Reminder set to On/Off Dose Limit Type set to: xxxxxx (xxxxxx= Total Dose/Number of Boluses/Max Allowed) Total Dose per x h(s) set to: xxx [units] (x = 1 or 4) Bolus Handle sound set to: X X = Always On, When Bolusing Intermittent Dose Complete. Volume infused: XX.X <units> Dose Time set to: xxx Pump stopped with immediate taper down Preset Programs were removed Medium Authorization level titration set to On/Off Catheter bucket changed from XX to YY PIEB set to: On/Off External Batteries connected External Batteries disconnected or depleted Catheter hysteresis conditions found: XX A/D Catheter check conditions found: XX A/D Drug Library was removed Loading Dose complete. Volume infused: XX.X mL Loading Dose quit prematurely. Volume infused: XX.X mL Loading Dose paused Loading Dose started Time set to: XX:XX h:min
Text changed
135 171 211 213 214 216 217 218 221 232 233 234 235 238 239 240 241 243 261 262 263 264 266 15025-048-0057-SM-01
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Text changed New events New events New events New event Text changed New event New event New event New event New event New event New event New event New event New event New event New event New event New event New event New event New event Page 5 of 14
SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Event Code
Text on Screen
Comments
267
Secondary Time set to: XX:XX h:min
268 269 270
Repeat Last Infusion Set to On/Off Allow Bolus set to On/Off Excessive environmental light
This event replaces event 170 New event New event New event
Changes in Chapter 7: Sapphire & SapphireH100; Section: Configuring General Settings Note: All updates in chapter 7 are relevant for Sapphire only (and not for SapphireH100). Update 1: A new menu under Pump Configuration named Audio settings Setting
Description
Default Value
Keys Volume
Sets the speaker volume for the auditory signal generated when users select functions and press 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 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 606011-8. 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.
Maximum
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, when the bolus handle is pressed and bolus is available.
On
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Update 2: The General settings menu was updated Setting
Description
Default Value
Current CCA
Used to select the CCA to which the pump should be set. Appears only when a Drug Library is loaded. 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.
NA
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.
Off
Start Up Config.
Authorization level Allow delayed start
Set Prime Volume
Backlight
Prime Reminder Advanced Bolus
Bolus Reminder
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Repeat Last Infusion- On PreProgram- Off
NA
20mL
On
Off Off
Off
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Setting
Description
Auto. P. Lockout
Enables/disables Patient Lockout, a safety feature that requires password entry to make any parameter changes. When the option is enabled, Patient Lockout is activated automatically when an infusion begins. Screen Saver Enables/disables a far-view display of the main infusion parameters during a running infusion. These include drug information, delivery mode (color indication), infusion rate, and the phase (dose, continuous rate etc.). The screen saver appears 30 seconds after the infusion program has started, and the pump has not been touched. The screen saver will not appear in the following cases: Delayed start, end of infusion KVO, or during a Bolus delivery. The screen saver will disappear in the following cases: • Alarm – screen will revert to the alarm screen • Touching the screen – screen will revert to the Running screen • Infusion is paused – screen will revert to the Paused screen. To save changes press Next and then OK.
Default Value Off
Off
Changes in Chapter 7: Sapphire & SapphireH100; Section: Defining Regional Parameters Update: The US format option was moved to the Regional menu The US format option was moved from the menu: Technician options->Pump settings->General to the menu: Pump configuration->Regional. Select the US format row to toggle the option between On and Off.
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 7: Sapphire & SapphireH100; Section: Managing Pump settings, Setting hard limits Update 1: The hard limits table of TPN and Intermittent delivery modes was updated Delivery Mode
VTBI
TPN
V
Intermittent
V
Max Dose Time
Int. Dose
V
V
Update 2: The hard limits table of PCA, PCEA and Epidural Intermittent delivery modes was updated Delivery Mode
VTBI
PCA
Int. Dose
Continuous Rate
Demand Bolus*
Loading Dose
Bolus Rate
Min Bolus Max Bolus Lockout Lockout
V
V
V
V
V
V
V
PCEA
V
V
V
V
V
V
Epi. Int
V
V**
V**
V
V**
* Changing the hard limits of the Demand Bolus parameter also applies to the Clinician Bolus parameter. ** This option’s hard limits can be changed only when PIEB is set to On (in the Epi. Int. menu). Changes in Chapter 7: Sapphire & SapphireH100; Section: Managing Pump settings, Resetting the System Update: The Reset system menu was updated The Reset System option is used to: 1. 2. 3. 4.
Revert all pump parameters and features to the factory default settings Define new security passwords Remove the Drug Library Remove the PrePrograms
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Factory defaults
Select Factory defaults. The Attention screen appears To confirm the reset press OK
Changes are saved in the system and the Start Up screen appears. Passwords
Select Passwords Select authorization level or PreProgram password to change In PreProgram enter a 4-digit password in the specified range [1000 - 9999]. In an authorization level enter a 4-digit password in the specified range [1000 - 7000]
Note: Passwords for each security level must be unique and in the specified range. The OK button will be disabled when entering the same password for more than one security level. The PreProgram password can be identical to an authorization level password, yet there isn’t any connection between the options the authorization level enables and the PreProgram option. Press OK to save the changes.
Remove Drug Library The Drug Library can be removed by Technician authorization level users only. This option will be hidden if there is no Drug Library on the pump. When the user removes the Drug Library all parameters are set to factory defaults.
Select Remove Drug Library Press OK to confirm. The Start Up screen will appear
Remove PrePrograms Enables to remove all preset programs installed on the pump (in all delivery modes).
Select Remove PrePrograms Press OK to confirm. The Start Up screen will appear
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 7: Sapphire & SapphireH100; Section: Managing Pump settings, Configuring General Settings Update: The menu General under Pump settings (under Tech. options) was updated Setting
Description
Default Value
Delivery Mode
Determines the available delivery modes. Each mode can be turned off separately. Allows users to associate an infusion with patient identification parameters, and reset the Accumulated VI (accumulated volume infused). Enables the pump to automatically restart an infusion, up to 5 times an hour, if a downstream occlusion was detected and cleared within 40 seconds. Determines if the user enters final concentration or Drug Amount and Diluent Volume. Enables the user to use units other than mL/h. If this option is disabled, programming will automatically default to mL/h. This feature is available in the absence of a Drug Library on the pump. Allows users with medium authorization level to change rate during a running infusion.
On
New patient
Occ. Auto-restart
Calculate Concentration mL/h only
Med. Titration
Off
On
Off Off
Off
The following settings appear only when the pump is in Continuous delivery mode: Setting
Description
Set Secondary (Piggyback) Allow Bolus
Allows users to program a Secondary infusion. Allows users to program a bolus during a Continuous infusion. When this feature is enabled, the Bolus button appears in the toolbar during the running infusion. Bolus Rate Specifies the rate of delivery of a fast dose, for rapid volume infusion. Sec. Bolus Rate Specifies the rate of delivery of a fast dose for a Secondary (Piggyback) infusion. To save changes press Next and then OK.
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Default Value Off Off
125 mL/h 125 mL/h
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Update: The table at page 142 was updated The following settings appear only in PCA, PCEA and Epi. int Options menu (relevant for Sapphire only). Setting
Description
Default Value
Limit Period
Specifies the time period to which the dose limit type is applied (during the selected time, the delivered boluses will be limited by either maximum number, or by maximum volume). Options are 1 hour or 4 hours.
1 h(s)
Changes in Chapter 7: Sapphire & SapphireH100; Section: Alarms and Troubleshooting, Level 2 Alarms Update: The alarm titled Battery Fault regarding battery tampered was canceled Changes in Chapter 7: Sapphire & SapphireH100; Section: Alarms and Troubleshooting, Level 3 Alarms Update: Alarms added to the Level 3 Alarms table Alarm Title
Displayed Text
Air in Line
Please prime administration set. If problem reoccurs, remove and reinsert the cassette Possible excessive environmental light. Please reduce exposure and check if priming is required.
Air in Line
Changes in Chapter 7: Sapphire & SapphireH100; Section: Alarms and Troubleshooting, Messages Update: New message A new message was added: Key stuck. Please release the key.
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 7: Sapphire & SapphireH100; Section: Alarms and Troubleshooting, Guidance in Problem Solving, Alarms Description List Update: New type of Air in Line alarm Alarm Title
Description
Solution
Air in Line
Excessive environmental light, in addition to the regular Air in Line conditions, was detected
Normal course of operation. Not a pump malfunction
Changes in Chapter 7: Sapphire & SapphireH100; Section: Upgrading Software Version Update 1: Instructions to perform when upgrading from software revision 11 to software revision 13.2 After verifying the software was uploaded successfully, change the mL/h only setting - if it is set to On change it to Off; If it is set to Off change it to On:
Enter the menu: Options->Technician options->Pump settings->General. Press Next Toggle the mL/h only setting
Update 2: Two troubleshooting cases were added to the troubleshooting table Problem
Solution
Prime button on Start Up screen is disabled Move to another screen or restart the pump. after SW upload The Prime button will be enabled. After upgrading from revision 11 to revision o Enter the menu: Options->Technician 13.2, the Dose calculation option doesn’t appear options->Pump settings->General. Press in the Dosing method window, even though it Next was available in revision 11 before the software o Verify that the mL/h only setting is set upgrade to Off
Changes in Chapter 8: SapphirePlus; Section: Using Technician Options, Configuring General Settings Update: There is no default value for the WiFi option
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SERVICE MANUAL LEVEL 1 Rev 01 – ADDENDUM 2 15025-048-0027-SM Rev 01, updated to Sapphire SW Rev13 Changes in Chapter 8: SapphirePlus; Section: Alarms and Troubleshooting, Level 2 Alarms Update: The alarm titled Battery Fault regarding battery tampered was canceled Changes in Chapter 8: SapphirePlus; Section: Alarms and Troubleshooting, Level 3 Alarms Update: Alarm added to the Level 3 Alarms table Alarm Title
Displayed Text
Air in Line
Please prime administration set. If problem reoccurs, remove and reinsert the cassette
Changes in Chapter 8: SapphirePlus; Section: Upgrading Software Version Update: To view the current SW version select: Options->View->View system. Press Next
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