Hospira
Sapphire Infusion Pumps
Sapphire R15 Infusion Pump Manual Configuration Settings Technician Options sw rev R15 June 2019
Manual Configuration Settings
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Manual Configuration Settings
SAPPHIRE™ INFUSION PUMP Software revision R15
Please set the authorization level to: "Technician" Note: Prior to configuring the pump, the authorized technician must read the Sapphire™ Infusion Pump Service Manual. Mode Specific settings will only be visible when in that selected mode. The pump configuration is set by the drug library, but local changes on the pump can be temporarily made. Note: This advisory document does not replace the official Instructions for Use . Read the User Manual and any instructions accompanying disposables or accessories before operating the Sapphire device.
CONFIGURATION SETTINGS Pump Configuration | Alarms
ALARMS MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
All
Occlusion Units
BAR, PSI, mmHg
BAR
The format of occlusion units.
All
Occlusion Pressure
0.4-1.2 (BAR) 5.8-17.4 (PSI) 300-900 (mmHg)
0.4 (BAR)
The minimum downstream pressure that triggers an Occlusion alarm.
Pump Unattended
2 min, 5 min, 10 min
10 min
The number of consecutive minutes of no interaction with the pump after which a “Pump Unattended” alarm is triggered. Note: A “Pump Unattended” alarm is not triggered when the pump is in Delayed start or Standby.
Infusion Near End
1 min, 3 min, 5 min, 10 min, Off
10 min
The number of minutes before completion of an infusion at which an “Infusion Near End” alarm is generated. Note: The “Infusion Near End” alarm is triggered once each treatment.
Maximum
Sets the speaker volume for the auditory alarm signal. 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. Refer to the User Manual for Level 1, 2, 3 alarm details.
All
All
All
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Alarm Volume
Maximum, Minimum
FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS Pump Configuration | Audio Settings
AUDIO SETTINGS MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
All
Keys Volume
Low, High, Off
High
Sets the speaker volume for the auditory signal generated when users select functions and press keys on the pump.
Maximum
Sets the speaker volume for the auditory alarm signal. 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. Refer to the User Manual for Level 1, 2, 3 alarm details.
Always On
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.
All
Alarm Volume
Maximum, Minimum
PCA PCEA Intermittent
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Bolus Handle
Always On, When Bolusing
FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS Pump Configuration | General Settings
GENERAL SETTINGS MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
FACILITY SETTING
PARAMETER DESCRIPTION
All
Start Up Configuration: Repeat Last Infusion
On, Off
On
Allows the user to start infusions, using the same infusion parameters for the same patient. When the option is enabled, the Repeat Last Infusion button appears on the pump Start screen.
All
Start Up Configuration: PreProgram
On, Off
Off
Allows the user to start an infusion using predefined in parameters. When the option is enabled, the PreSet Programs button appears on the pump Start Up screen.
All
Authorization Level
Low, Medium, High, Technician
NA
Sets the authorization lock level of the pump.
All
Allow Delayed Start
On, Off
Off
Enables users to start an infusion at a later time. The user may either define a specific delay period, or set the pump to Standby.
All
Set Prime Volume
2-25 mL
20 mL
The amount of fluid used to prime the administration set when automatic priming is performed.
All
Backlight
On, Off, Partial
On
Allows the user to set the degree of screen brightness for a running infusion. Backlight can also be modified during a running infusion. The Off and Partial options of this feature save power and promote longer battery life.
All
Prime Reminder
On, Off
Off
Enables a reminder for the user to prime the administration set before starting an infusion.
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CONFIGURATION SETTINGS Pump Configuration | General Settings
GENERAL SETTINGS (CONT.) MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
Continuous
Advanced Bolus
On, Off
Off
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.
Off
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
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 as the infusion begins, and automatically re-activated throughout the infusion.
Off
Enables/disables a far-view display of the main infusion parameters during a running infusion. The screen saver appears 30 seconds after the infusion program has started, and the pump has not been touched.
PCA PCEA
Bolus Reminder
On, Off
Intermittent
All
All
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Auto Patient Lockout
Screen Saver
On, Off
On, Off
FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS Pump Configuration | Regional
REGIONAL MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
All
Date
dd/mm/yr mm/dd/yr*
mm/dd/yr
All
Time
Current Time
12 hour clock
FACILITY SETTING
PARAMETER DESCRIPTION
The Regional menu controls date, time, language and US format settings. All
Language
English
English
All
US Format
On, Off
On
*When US format is enabled.
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CONFIGURATION SETTINGS Mode Specific Options | PCA Options
PCA OPTIONS MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
FACILITY SETTING
PARAMETER DESCRIPTION
Bolus Rate
1 - 600 mL/h
125 mL/h
The rate at which a bolus (patient bolus, clinician bolus and loading dose) is delivered.
Allow Loading Dose
On, Off
On
Enables the user to program a loading dose (starting the infusion with a clinician bolus).
Infusion Type
Bolus Only, Continuous Only, Continuous + Bolus
Continuous + Bolus
Defines the PCA infusion type that is available for the user.
Limit Period
4 hours 1 hour
1 hr(s)
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 maximum volume).
PCA
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CONFIGURATION SETTINGS Mode Specific Options | PCEA Options
EPIDURAL PCEA OPTIONS MODES
PCEA
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PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
FACILITY SETTING
PARAMETER DESCRIPTION
Bolus Rate
125 mL/h 200 mL/h
125 mL/h
The rate at which a bolus (patient bolus, clinician bolus and loading dose) is delivered.
Password Request
No, Yes
No
Enables a safety feature that requires a high authorization level password entry for programming and editing actions.
Allow Loading Dose
On, Off
On
Enables the user to program a loading dose (starting the infusion with a clinician bolus).
Infusion Type
Bolus Only, Continuous Only, Continuous + Bolus
Continuous + Bolus
Defines the PCEA infusion type that is available for the user.
Limit Period
4 hours 1 hour
1 h(s)
Specifies the time period to which the dose limit type is applied (during the selected time, the delivered boluses are limited by either maximum number or by maximum volume).
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CONFIGURATION SETTINGS
Mode Specific Options | Epidural intermittent (Epi. Int) Options
EPIDURAL INTERMITTENT OPTIONS MODES
Epidural
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
Dose Rate
125 mL/h 200 mL/h
125 mL/h
The rate at which an intermittent dose is delivered.
Password Request
No, Yes
No
Enables a safety feature that requires a high authorization level password entry for programming and editing actions.
Limit Period
4 hours 1 hour
1 h(s)
Specifies the time period to which the dose limit type is applied (during the selected time, the delivered boluses are limited by either maximum number or by maximum volume).
PIEB*
On, Off
Off
Enables the user to program a PIEB infusion
Intermittent
FACILITY SETTING
PARAMETER DESCRIPTION
*PIEB - Programmed Intermittent Epidural Bolus
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set Hard Limits
SET HARD LIMITS: MODE SPECIFIC MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
Primary VTBI
1-9999 mL
9999 mL
The total amount of fluid to be infused in a primary infusion.
Primary Rate
0.1-999 mL/h
999 mL/h
The speed at which the fluid is infused in a primary infusion.
Secondary VTBI
1-9999 mL
9999 mL
The total amount of fluid to be infused in a secondary infusion. In order to configure: Set Secondary must be turned On in the General Menu.
Secondary Rate
0.1-500 mL/h
500 mL/h
The speed at which the fluid is infused in a secondary infusion. In order to configure: Set Secondary must be turned On in the General Menu.
VTBI
1-9999 mL
9999 mL
The total amout of fluid to be infused.
Maximum Dose Time
00:01-96:00 h:min
96:00 h:min
The maximum period of time over which the intermittent dose is delivered.
Intermittent Dose
0.1 - 999 mL/h
999 mL/h
The amount of each intermittent dose.
Continuous
Intermittent
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FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set Hard Limits
SET HARD LIMITS: MODE SPECIFIC (CONT.) MODES
Multi-step
PCA
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PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
FACILITY SETTING
PARAMETER DESCRIPTION
VTBI
1-9999 mL
9999 mL
The total amout of fluid to be infused.
Rate
0.1-999 mL/h
999 mL/h
The speed at which the fluid is infused.
Time
00:01-24:00 h:min
24:00 h:min
The period of time over which the fluid is infused. The acceptable range for time values vary according to the VTBI.
VTBI
1-9999 mL
9999 mL
The total amount of fluid to be infused.
Continuous Rate
0.1-99.9 mL/h
99.9 mL/h
The rate of the basal infusion.
Demand Bolus
0.1-30 mL
20 mL
The amount of fluid infused in a single bolus. Changing the hard limits of the Demand Bolus parameter also applies to the Clinician Bolus parameter.
Loading Dose
0.1-30 mL
20 mL
An optional feature that begins the infusion with a clinician bolus.
Bolus Rate
1-600 mL/h
600 mL/h
The speed at which the bolus is infused.
Minimum Bolus Lockout
00:01-24:00 h:min
00:01 h:min
The minimum time that must pass between the end of one bolus to the start of the next bolus.
Maximum Bolus Lockout
00:01-24:00 h:min
24:00 h:min
The maximum time that is allowed between the end of one bolus to the start of the next bolus. 11 of 20
CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set Hard Limits
SET HARD LIMITS: MODE SPECIFIC (CONT.) MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
TPN
VTBI
1-9999 mL
9999 mL
The total amout of fluid to be infused.
VTBI
1-9999 mL
9999 mL
The total amount of fluid to be infused.
Continuous Rate
0.1-25 mL/h
25 mL/h
The speed at which the fluid is infused.
Demand Bolus
0.1-30 mL
20mL
The amount of fluid infused in a single bolus. Changing the hard limits of the Demand Bolus parameter also applies to the Clinician Bolus parameter.
Loading Dose
0.1-30 mL
20 mL
An optional feature that begins the infusion with a clinician bolus.
Minimum Bolus Lockout h:min
00:01-24:00 h:min
00:01 h:min
The minimum time that must pass between the end of one bolus to the start of the next bolus.
Maximum Bolus Lockout h:min
00:01-24:00 h:min
24:00 h:min
The maximum time that is allowed between the end of one bolus to the start of the next bolus.
Epidural PCEA
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FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set Hard Limits
SET HARD LIMITS: MODE SPECIFIC (CONT.) MODES
Epidural Intermittent
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
FACILITY SETTING
PARAMETER DESCRIPTION
VTBI
1-9999 mL
9999 mL
The total amout of fluid to be infused.
Intermittent Dose
0.1-30 mL/h
20 mL
The amount of each intermittent dose.
Demand Bolus*
0.1-30 mL
20mL
The amount of fluid infused in a single bolus. Changing the hard limits of the Demand Bolus parameter also applies to the Clinician Bolus parameter.
Minimum Bolus Lockout*
00:01-24:00 h:min
00:01 h:min
The minimum time that must pass between the end of one bolus to the start of the next bolus.
Maximum Bolus Lockout*
00:01-24:00 h:min
24:00 h:min
The maximum time that is allowed between the end of one bolus to the start of the next bolus.
*Available when PIEB is enabled under Epidural Intermittent Options.
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set KVO
SET KVO MODES
OPTIONS/RANGE
DEFAULT SETTING
Continuous
0-20 mL/h
3 mL/h
Multi-step
0-20 mL/h
3 mL/h
PCA
0-20 mL/h
0 mL/h
TPN
0-20 mL/h
3 mL/h
Epidural
0-20 mL/h
0 mL/h
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FACILITY SETTING
PARAMETER DESCRIPTION
The KVO screen of each delivery mode provides access to setting KVO rates for all other delivery modes, with the exception of Intermittent and Epidural Intermittent. For Intermittent and Epidural Intermittent, KVO rate is programmed for every infusion.
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Set Air Detector
SET AIR DETECTOR MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
All
Single Air Detector
0.02 mL, 0.04 mL, 0.05 mL, 0.1 mL, 0.2 mL, 0.5 mL, Off
*Off
All
Accumulated Air Detector
0.02 mL, 0.04 mL, 0.05 mL, 0.1 mL, 0.2 mL, 0.5 mL
0.5 mL
All
Accumulated Threshold
0.5 mL, 1 mL, Off
1 mL
All Excluding Epidural
*
Air Detection
On/ Off
On
FACILITY SETTING
PARAMETER DESCRIPTION In this mechanism, every time that a single bubble equal to or larger than a user-selected size passes through the detector, an alarm is triggered. In this mechanism, the user selects the values for both accumulated bubble size and the accumulated amount (threshold). Any single bubble equal to or larger than the selected accumulated bubble size is included in the counter of accumulated air. When the total amount of accumulated air reaches the selected accumulated threshold value in a 15 minute period, an alarm is triggered. Determines whether the pump air detection is disabled (OFF) or enabled (ON) during infusion. This feature should be used when meeting the clinical practice and guidelines and coupled with an alternative method of eliminating air. When the air detection is disabled (OFF) the user is prompted to use a set with an air-eliminating filter.
If an infusion is running at a rate of 1-4 mL/h or lower, the single air detector will automatically switch on to 0.5 mL. If an infusion is running at a rate lower than 1 mL/h, the single air detector will automatically switch on to 0.1 mL.
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | Reset System
RESET SYSTEM: PASSWORDS MODES
PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
All
High Level
1000-7000
7770
All
Medium Level
1000-7000
8880
All
Low Level
1000-7000
9990
All
PreProgram
1000-9999
7770
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FACILITY SETTING
PARAMETER DESCRIPTION
To help ensure patient safety, the Sapphire™ pump can be set to one of four authorization levels. Only a Technician authorization level may set the customized default setting.
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | General
GENERAL: MODE SPECIFIC MODES
DELIVERY MODES (for Epidural Intermittent)
All
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PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
Continuous
On, Off
On
Multi-step
On, Off
On
Intermittent
On, Off
On
TPN
On, Off
On
PCA
On, Off
On
PCEA
On, Off
On
Intermittent
On, Off
On
New Patient
On, Off
Off
FACILITY SETTING
PARAMETER DESCRIPTION
Determines the available delivery modes. Each mode can be turned off separately.
The Sapphire™ pump allows you to associate infusions to a specific patient. When New Patient feature is enabled, the New Patient screen appears. The pump calculates the accumulated volume infused and accumulated bolus history and zeroes them out when New Patient is identified during programming.
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | General
GENERAL: MODE SPECIFIC (CONT.) PARAMETER
OPTIONS/RANGE
DEFAULT SETTING
Set Secondary (Piggyback)
On, Off
Off
Allows users to program a Secondary infusion.
Allow Bolus
On, Off
Off
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
0.1-999 mL/h
125 mL/h
Specifies the rate of delivery of a fast dose, for rapid volume infusion.
Secondary Bolus Rate
0.1-500 mL/h
125 mL/h
Specifies the rate of delivery of a fast dose for a Secondary (Piggyback) infusion.
All
Occlusion Autorestart
On, Off
On
Enables the pump to restart the infusion automatically provided the occlusion was cleared within 40 seconds. An Occlusion Auto-restart can occur up to 5 times an hour.
All Excluding TPN
Calculate Concentration
On, Off
Off
Determines if the users enter final concentration or Drug Amount and Diluent Volume.
All Excluding TPN
mL/h only
On, Off
Off
Allows users to use units other than mL/h. If this option is enabled, programming will automatically default to mL/h. This feature is available in the absence of a Drug Library on the pump.
All
Medium Titration
On, Off
Off
Allows users with medium authorization level to change rate during a running infusion.
MODES
Continuous
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FACILITY SETTING
PARAMETER DESCRIPTION
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CONFIGURATION SETTINGS
Technician Options | Pump Settings | General
SAPPHIRE™ CONFIGURATION SETTINGS DEFINED AND AGREED NAME
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DATE
SIGNATURE
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Q Core Medical Ltd 29 Yad Haruzim St., P.O.Box 8639 Netanya 4250529, Israel T +972.73.2388888 F +972.73.2388800 [email protected] 15025-050-0072 | Rev.00 / 06.2019