CADD-Solis Administrator Settings Guide Model 2100

The CADD®-Solis ambulatory infusion system is designed to promote patient care and safety for a variety of adult and pediatric patients and clinical care areas, including, but not limited to, postoperative, trauma, critical care, oncology, and labor and delivery. This guide concerns only the CADD®Solis ambulatory infusion pump. This pump can be programmed with a pump protocol configuration, consisting of a therapy, qualifier, and drug. The pump can deliver medication at a constant rate and/ or with a bolus dose. This guide is intended for use by the facility’s CADD®-Solis system administrator or authorized facility staff only, do not permit unauthorized clinicians or patients to have access to it. The pump has three security levels designed to limit overall patient and clinician access to certain pump features. Only disclose the pump’s security codes to those who are authorized. Patient and unauthorized clinician access to the pump key should also be restricted. The issue date of this Administrator Settings Guide is included on the back cover. In the event one year has elapsed between the issue date and product use, the clinician should contact Smiths Medical to see if an updated revision of this guide is available.

Technical Assistance If you have comments or questions concerning the operation of the CADD®-Solis ambulatory infusion pump, please call the number given below. When calling, please specify the pump’s software version number. This information is located in the Device Information Report (See the Reports section in the CADD®-Solis Operator’s Manual for more information). Our staff at Smiths Medical is available to help twenty-four hours a day with the programming and operation of the CADD®-Solis ambulatory infusion pump. U.S. Distribution:

European Distribution:

Smiths Medical MD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 1 800.426.2448 +1 651.633.2556 www.smiths-medical.com

Smiths Medical International Ltd. WD24 4LG UK +44 (0)1923 246434

Read the entire Administrator Settings Guide and Operator’s Manual before operating the CADD®Solis ambulatory infusion pump. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

WARNINGS • The Administrator Settings Guide should be used by authorized clinicians only. Do not permit patients or unauthorized clinicians to have access to this guide, as the information contained would allow complete access to all programming and operating functions. • To avoid explosion hazard, do not use the pump in the presence of flammable anesthetics or explosive gases. • If the pump is dropped or hit, inspect the pump for damage. Do not use a pump that is damaged or is not functioning properly. Contact Smiths Medical’s Customer Service to return a pump for service. • Do not disclose the pump’s security codes or any other information that would allow the patient or unauthorized clinicians complete access to programming and operating functions. • Do not leave the pump unattended while unlocked with the administrator security code. • When the Air Detector is turned Off, the pump will not detect air in the fluid path. It is recommended that you periodically inspect the fluid path and remove any air to prevent air embolism. • When the upstream occlusion sensor is turned off, the pump will not detect occlusions upstream (between pump and fluid container). Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Occlusions may result in under or non-delivery of medications.

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Table of Contents Technical Assistance... 1 WARNINGS... 1

Overview: Administrator Settings...3

To access the administrator settings... 3 Administrator Settings Programming Screens/Menu Map... 4

Delivery Settings...5

Maximum and Minimum Limits, and Current Value... 5 Continuous Rate... 5 PCA Dose... 6 PCA Lockout... 6 Delivery Limit Method... 6 Delivery Limit Period... 7 Delivery Limit Amount... 7 Max Doses/Hr... 8 Reservoir Reset Volume... 8 Max Delivery Rate... 8 Clinician Bolus... 9

Alarm Settings...10 Pump Stopped Alarm Type... 10 Reservoir Low Trip Point... 10 Reservoir Low Alarm Type... 11 Air Detector On/Off... 11 Air Detector Sensitivity... 11 Upstream Occlusion Sensor On/Off... 12 Downstream Occlusion Sensor Sensitivity... 12 PM (Preventative Maintenance) Reminder On/Off... 12 PM Reminder... 13 Reservoir Empty Alarm Type... 13

Security Settings... 14

Keypad Code... 14 Clinician Code... 14 Administrator Code... 15 Manual Programming Security... 15 Keypad Security... 15 Security Level Table... 16

Set Time and Date... 17 Display and Sound... 19

Home Screen Settings... 19 Adjust Backlight Intensity... 19 Adjust Alarm Volume... 19 Sound Theme...20 Key Beep On/Off...20

Default to Factory Settings...21 Index...22

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Overview: Administrator Settings The administrator settings contain pump configurations that are set up by an administrator. Protocol libraries, consisting of therapies, qualifiers, and drugs are generally created using the CADD®Solis Medication Safety Software. The administrator settings allow you to make changes to an individual protocol for single use. NOTE: When editing the administrator settings, it is important to note that the edits being made only affect the currently displayed protocol. NOTE: The administrator settings screens will revert to the home screen when there is a four minute delay between button presses. Make sure you are still in the administrator settings menu after any delays. NOTE: Many of the following instructions include steps to unlock the keypad. This step will only be necessary if the keypad is not already unlocked.

To access the administrator settings 1. From the Home screen, select Tasks.

4. Press U or D to scroll through the administrator settings menu, then press S to access the editing screens. Follow the instructions on the following pages for the appropriate screen. To Press here to go Back exit a screen without changing a setting, select Back or Don’t Save. WARNING: • Do not disclose the pump’s security codes or any other information that would allow the patient or unauthorized clinicians complete access to programming and operating functions. Improper programming could result in serious patient injury or death. • Do not leave the pump unattended while unlocked with the administrator security code. All programming functions can be accessed with this code and improper programming could result in serious patient injury or death.

Press here to select Tasks

2. Press U or D until Adjust Admin Settings is highlighted, then press S.

3. Press U or D to enter the administrator ** Text Omitted **

Press here to Accept Value

NOTE: See Security Settings on page 14 to create a custom security code. 3

Administrator Settings Programming Screens/Menu Map Admin Settings

Security

Delivery

Keypad Code

Alarms

Clinician Code

Security

Admin Code

Set Time and Date

Manual Programming Security

Display and Sound

Keypad Security

Default to Factory Settings

Set Time and Date Current Time

Delivery

Current Date

Continuous Rate

Date Format

PCA Dose PCA Lockout Delivery Limit Method

Home Screen Settings

Delivery Limit Period*

Adjust Backlight Intensity

Delivery Limit Amount*

Adjust Alarm Volume

Max Doses/Hr*

Sound Theme

Reservoir Reset Volume

Key Beep On/Off

Max Delivery Rate Clinician Bolus *Editable in Admin Settings even when unavailable in the protocol. Will not appear on the menu screen if it is not selected in the delivery limit method. Alarms Pump Stopped Alarm Type Reservoir Low Trip Point Reservoir Low Alarm Type Air Detector On/Off Air Detector Sensitivity* Upstream Sensor On/Off Downstream Sensor Sensitivity PM Reminder On/Off PM Reminder* Reservoir Empty Alarm Type *May not appear on the menu if the parameter is set to “off.”

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Display and Sound

Default to Factory Settings Reset pump to default factory settings?

Delivery Settings

Delivery Settings The delivery settings are attributes of a protocol that are directly related to the drug being infused. Changes to any of these have a direct impact on the amount of drug being delivered to the patient. The programming units (mg, mcg, mL) and concentration (if applicable) used for each configuration will be dependent on the current protocol. The programming units and concentration of a protocol cannot be changed. A new protocol must be selected (through the tasks menu) in order to change programming units. Any changes made in the delivery settings menu affect only the protocol that is currently displayed. To access the Delivery Settings, press U or D to choose Delivery in the administrator settings menu and press S. NOTE: Editing the delivery settings causes the color of the protocol on the screen to change to black. This is to alert clinicians that a manual change has been made to the protocol that is currently active in the pump. NOTE: Clicking “Save,” even if you did not adjust any of the limits, causes the color of the protocol on the screen to change to black. To exit an editing screen, always press “Don’t Save” if you are not making any changes.

Maximum and Minimum Limits, and Current Value Within several of the delivery settings feature screens, you are given the option to set hard and soft maximum and minimum limits, as well as the current value. Below is a definition of these settings: Hard Maximum - The maximum value for the parameter being edited. It will not be possible for the clinician to program the setting above the hard maximum value within the current protocol. Soft Maximum - The soft maximum value should be the highest common value for the setting you are programming. It may be programmed above this value, though extra confirmation will be required.

Current Value - Displays the current value for the setting in the protocol. Changing this value changes the currently programmed value in the patient specific parameters. Soft Minimum - The soft minimum value should be the lowest common value for the setting you are programming. It may be programmed below this value, though extra confirmation will be required. Hard Minimum - The minimum value that the setting being edited should ever be programmed to. It is not possible for the clinician to program the setting below the hard minimum value within the current protocol. If a clinician programs one of these settings above a soft maximum or below a soft minimum, there is a screen requiring the clinician to confirm the soft limit override. NOTE: The hard and soft minimum values may be left at zero, or the lowest available value if you are not trying to prevent the clinician from choosing too low of a value for the parameter.

Continuous Rate The continuous rate option allows you to configure the maximum and minimum program limits, as well as change the current value for the continuous rate. If the maximum program limit is not available with a given concentration, the feature will not scroll. If a current programmed value for the continuous rate is outside a newly programmed maximum limit, the current value for the continuous rate will be set to zero. To program the continuous rate limits and current value: 1. In the delivery settings menu, press U or D to choose Continuous Rate and press S. 2. To adjust the hard max, press U or D until you reach the hard max option, press S.

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Delivery Settings 3. Press U or D until you reach the desired value and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

PCA Lockout The PCA lockout option allows you to designate the limits for the period of time that must pass before the patient can successfully request another PCA dose. Press here to Save

Continue with this process until all of the continuous rate limits are programmed to the desired value.

PCA Dose The PCA dose option allows you to configure the maximum and minimum PCA dosing limits, as well as change the current value for the PCA dose. If the maximum program limit is below the minimum increment for a given concentration, the feature will not scroll. If a current programmed value for a parameter is outside a newly programmed maximum limit, the current PCA dose will be set to zero. To program the PCA dose: 1. In the delivery settings menu, press U or D to choose PCA Dose and press S.

3. Press U or D until you reach the desired limit and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Continue with this process until all of the PCA lockout limits are programmed to the desired value.

You may use the delivery limit method to designate one of three methods to restrict the total amount of the drug available to the patient. NOTE: The available doses will always be limited by the PCA lockout time programmed as part of the patient specific parameters. The three options that are available to you are: Not in Use - No additional dose limits will be programed. PCA doses will be limited by the PCA lockout time only.

Press here to Save

Continue with this process until all of the PCA dose limits are programmed to the desired value. 6

2. To adjust the hard max, press U or D until you reach the hard max option, press S

Delivery Limit Method

2. To adjust the hard max, press U or D until you reach the hard max option, press S. 3. Press U or D until you reach the desired limit and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

1. In the delivery settings menu, press U or D to choose PCA Lockout and press S.

Delivery Limit - Allows you to use an hourly delivery limit to limit the amount of drug available to the patient in a specified time frame (1-12 hours). Values counted toward the delivery limit are the continuous rate and PCA dose amounts given. Clinician activated boluses are not counted toward the delivery limit.

Delivery Settings Max Doses/Hr - Allows you to restrict the number of doses available to the patient each hour. This option is used to restrict PCA doses beyond the restrictions determined in the PCA lockout time. To choose a delivery limit method: 1. In the delivery settings menu, press U or D to choose Delivery Limit Method and press S. 2. Press U or D to choose Not In Use, Delivery Limit, or Max Doses/Hr and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

or Don’t Save to exit without saving (protocol color will not change). NOTE: If the delivery limit method “not in use” or “max doses/hr” are selected, this option will be hidden and you will not be able to edit it.

Press here to Save

Delivery Limit Amount When “Delivery Limit” is chosen as the delivery limit method, the delivery limit amount option allows you to specify the maximum drug amount (mg, mcg, mL) available in the time specified by the delivery limit period. You may also set the current value here. Press here to Save

NOTE: Once you have selected a delivery limit method, the other delivery limit options will not be available to you on the delivery settings screen.

NOTE: When activated, a clinician bolus does not count toward the delivery limit. To set the delivery limit amount:

Delivery Limit Period

1. In the delivery settings menu, press U or D to choose Delivery Limit Amount and press S.

When “Delivery Limit” is the selected delivery limit method, the delivery limit period option allows you to choose the time frame within which you are limiting drug delivery via continuous rate and PCA doses.

2. To adjust the hard max, press U or D until you reach the hard max option, press S.

NOTE: When activated, a clinician bolus does not count toward the delivery limit. The delivery limit period can be set anywhere from 1 to 12 hours in 1 hour increments. To program the delivery limit period: 1. In the delivery settings menu, press U or D to choose Delivery Limit Period and press S. 2. Press U or D until you reach the desired amount of time for the delivery limit period and select Save (protocol color will change)

3. Press U or D until you reach the desired amount and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Continue with this process until all of the delivery limit amount limits are programmed to the desired values. NOTE: If the delivery limit method “not in use” or “max doses/hr” are selected, this option will be hidden and you will not be able to edit it. 7

Delivery Settings

Max Doses/Hr When “max doses/hr” is chosen in the delivery limit method, it will allow you to set the maximum drug amount (mg, mcg, mL) as well as the current value. Max doses/hr allows the clinician to further restrict the number of doses available to the patient in 1 hour increments beyond what the PCA lockout feature allows. The max doses/hr range is affected by the current protocol’s PCA lockout time. To program the max doses/hr limits: 1. In the delivery settings menu, press U or D to choose Max Doses/ Hr and press S. 2. To adjust the hard max, press U or D until you reach the hard max option, press S. 3. Press U or D until you reach the desired amount and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

1. In the delivery settings menu, press U or D to choose Reservoir Reset Volume and press S. 2. Press U or D until the reservoir reset volume is at the desired value and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Max Delivery Rate

Press here to Save

Continue with this process until all of the max doses/hr limits are programmed to the desired values. NOTE: If the delivery limit methods “delivery limit” or “not in use” are selected, this option will be hidden and you will not be able to edit it.

Reservoir Reset Volume Each time a clinician attaches a new reservoir to the pump, the clinician will select the reservoir volume parameter in the protocol and reset the value to display the volume that is in the new reservoir. In the administrator settings, you may choose a standard reservoir volume, which allows the clinician to quickly reset the reservoir volume to that value. The clinician can adjust the reservoir 8

volume to another amount, if necessary. To program the reservoir reset volume:

The maximum delivery rate feature allows you to program the maximum speed at which the pump will deliver a PCA dose or clinician bolus. The maximum rate is the sum of the continuous rate and either the PCA dose or clinician bolus rate. For example, if the maximum delivery rate is programmed to 60 mL/hr, and the continuous rate is programmed to 15 mL/hr, a PCA dose or clinician bolus would be delivered at 45 mL/hr. The maximum rate is programmable from 40 to 175 mL/ hr in increments of 1 mL/hr. The default value is 175 mL/hr. To set the maximum delivery rate: 1. In the Delivery Settings menu, press U or D to choose Max Delivery Rate and press S. 2. Press U or D until the maximum delivery rate is at the desired level and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Delivery Settings

Clinician Bolus The Clinician Bolus option allows you to configure the maximum and minimum program limits for the Clinician Bolus. To program the clinician bolus limits: 1. In the Delivery Settings menu, press U or D to choose Clinician Bolus and press S. 2. To adjust the hard max, press U or D until you reach the hard max option, press S. 3. Press U or D until you reach the desired amount and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Continue with this process until all of the clinician bolus limits are programmed to the desired value.

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Alarm Settings

Alarm Settings In the protocol you are manually editing, you may adjust various alarm settings through the “Alarm” option in the administrator settings. Some of the settings you may adjust include whether or not an alarm is active, the type of alarm that will sound, and at what point the alarm will sound. There are 4 types of alarms that the pump can sound: High Priority – If the pump is running, it will always stop running when a high priority alarm is activated. The alarm is accompanied by a red screen, and it will persist until acknowledged by the press of a button on the pump or until the condition that triggered the alarm is gone (e.g. high pressure going down). The alarm can be silenced with a button press and will sound again after 2 minutes. Medium Priority – If the pump is running, a medium priority alarm will not stop the pump. The alarm is accompanied by an amber screen, and it will persist until acknowledged by the press of a button on the pump or until the condition that triggered the alarm is gone (e.g. a remote dose cord is reattached while the pump is running). The alarm can be silenced with a button press and will sound again after 2 minutes. Low Priority – If the pump is running, a low priority alarm will not stop the pump. The alarm is accompanied by a cyan (blue-green) screen, and it will persist for 5 seconds, unless it is acknowledged by the press of a button or the condition that triggered the alarm is gone before the 5 seconds have passed. Informational Priority – If the pump is running, an informational priority alarm will not stop the pump. This alarm appears on the status bar, it does not display a new alarm screen. It will persist for 5 seconds and is generally a silent alarm. To access the alarm settings, press U or D to choose Alarms in the administrator settings menu and press S.

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NOTE: Editing some of the alarm settings will cause the color of the protocol on the screen to change to black. This is to alert the clinician that a manual change has been made to the protocol currently active in the pump. NOTE: Clicking “Save,” even if you did not adjust any of the settings, will cause the color of the protocol on the screen to change to black. To exit an editing screen, always press “Don’t Save” if you are not making any changes.

Pump Stopped Alarm Type The pump stopped alarm allows you to select either a high priority or informational alarm to remind the clinician that the pump is stopped. To edit the pump stopped alarm type: 1. In the alarm settings menu, press U or D to choose Pump Stopped Alarm Type and press S. 2. Press U or D until the desired alarm type is highlighted, and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

Reservoir Low Trip Point The reservoir low trip point allows you to program the pump to alarm when the reservoir volume reaches a specified level. It can be programmed from 0 to 999 mL in 1 mL increments. If you prefer not to sound an alarm until the reservoir is empty, program the trip point to zero. Once activated, a medium or low priority alarm will sound, depending on the type of alarm that is selected in the reservoir low alarm type in the alarm settings menu.

Alarm Settings To program the reservoir low trip point:

Air Detector On/Off

1. In the Alarm Settings menu, press U or D to choose Reservoir Low Trip Point and press S.

The air detector on/off option allows you to control whether the air detector is turned on or off. If the air detector is turned on, an alarm will sound when air is detected in the fluid path. (See the Operator’s Manual for air detector specifications.)

NOTE: When programming the reservoir volume trip point, keep the programmed delivery rate of the pump in mind such that sufficient time is allowed to gather replacement supplies before the reservoir becomes empty. 2. Press U or D until the desired volume is highlighted and select Save.

For certain therapies, it may be desirable to turn the air detector off (for example, subcutaneous infusion). To turn the air detector on or off:

Press here to Save

Reservoir Low Alarm Type The reservoir low alarm type allows you to select either an “insistent and one time only” alarm (medium priority) or a “non-insistent and repeating” alarm (low priority) to inform the clinician that the reservoir volume is low. The “insistent and one time only” alarm will not reoccur once it has been acknowledged with a push of the button on the pump. The “non-insistent and repeating” alarm will repeat at the 75%, 50%, and 25% marks of the amount determined in the reservoir low trip point.

1. In the alarm settings menu, press U or D to choose Air Detector On/Off and press S. 2. Press U or D to choose either off or on and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change). Press here to Save

Air Detector Sensitivity If the air detector is programmed to be on, the air detector sensitivity option is available to allow you to customize how sensitive you want the pump to be to the air bubbles in the tubing. You may program the pump to have a high or low sensitivity. (See the Operator’s Manual for air detector specifications.)

1. In the alarm settings menu, press U or D to choose Reservoir Low Alarm Type and press S. 2. Press U or D until the desired alarm type is highlighted and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

WARNING: When the air detector is turned off, the pump will not detect air in the fluid path. It is recommended that you periodically inspect the fluid path and remove any air to prevent air embolism. Air embolism could cause serious patient injury or death.

1. In the alarm settings menu, press U or D to choose Air Detector Sensitivity and press S.

Press here to Save

NOTE: The air detector must be on to view this option. 11

Alarm Settings 2. Press U or D to choose either high or low and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Downstream Occlusion Sensor Sensitivity

Press here to Save

NOTE: Downstream occlusion sensor is always activated.

Upstream Occlusion Sensor On/Off An upstream occlusion is a blockage in the tubing between the pump and the fluid container. The pump contains a sensor that determines if there is an upstream occlusion. This feature can be set to on or off. If this sensor is set to on, and an upstream occlusion is detected, an alarm will sound, delivery will stop, and the display will show that there is an upstream occlusion. An upstream occlusion will only be detected with administration sets and bags. NOTE: The pump will not test for an upstream occlusion when using a medication cassette reservoir, even if the upstream occlusion sensor is set to “on.” WARNING: When the upstream occlusion sensor is turned off, the pump will not detect occlusions upstream (between pump and fluid container). Periodic inspection of the fluid path for kinks, a closed clamp, or other upstream obstructions is recommended. Occlusions may result in under or non-delivery of medications. If undetected, the occlusions could lead to serious patient injury or death. 1. In the alarm settings menu, press U or D to choose Upstream Sensor On/Off and press S. 2. Press U or D to choose either off or on and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change). 12

A downstream occlusion is a blockage in the tubing between the pump and the patient. The downstream sensor sensitivity option allows you to specify a high or low degree of response to pressure buildup in the downstream tubing. (See the Operator’s Manual for specifications on the downstream sensor sensitivity.)

1. In the alarm settings menu, press U or D to choose Downstream Sensor Sensitivity and press S. 2. Press U or D to choose either high or low and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

PM (Preventative Maintenance) Reminder On/Off If your facility establishes a maintenance program for the pump, you can use the PM reminder on/ off option to program the pump to sound an alarm when it is time for preventative maintenance. The message will begin appearing on the date programmed and during every power up until the date is reset. Use the PM reminder on/off screen to turn the alarm on and then continue to the PM reminder screen to specify the interval at which the message should appear, or use it to reset the reminder. 1. In the alarm settings menu, press U or D to choose PM Reminder On/Off and press S.

Press here to Save

Press here to Save

Alarm Settings

Reservoir Empty Alarm Type

2. Press U or D to choose either off or on and select Save.

The reservoir empty alarm type option allows you to select between two types of alarms when the reservoir is empty:

PM Reminder

One Time Only – When a reservoir empty alarm occurs, you will be required to press a button to acknowledge or silence the alarm. This alarm will not reoccur once it has been acknowledged.

Use the PM Reminder screen to schedule the amount of time that should pass before a PM reminder displays (1 to 24 months). If the PM reminder has been turned on in the PM reminder on/off screen, PM reminder will appear as an option in the alarm settings menu.

Repeat Until Removed or Reset – When a reservoir empty alarm occurs, you will be required to press a button to acknowledge or silence the alarm. The alarm is repeated every 5 minutes until the reservoir volume has been set to a new value, the reservoir is removed, or the pump is powered down.

NOTE: If PM reminder does not appear in the alarm settings menu, follow the preceding directions for turning the preventative maintenance reminder on in the PM reminder on/off screen.

To select the reservoir empty alarm type:

Press here to Save

To schedule the PM reminder: 1. After the PM reminder has been turned on in the PM reminder on/ off screen, press U or D to choose PM Reminder in the alarm settings menu, and press S. 2. On the next screen “PM Interval” will be highlighted, press S to edit it. Press U or D to choose the number of months that should pass before Press here to Reset the next preventative maintenance reminder. Confirm the “Next Reminder” date displayed and select Reset.

1. In the alarm settings menu, press U or D to choose Reservoir Empty Alarm Type and press S. 2. Press U or D to choose the desired alarm type and select Save (protocol color will change) or Don’t Save to exit without saving (protocol color will not change).

Press here to Save

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Security Settings

Security Settings The security settings option in the administrator settings allows you to customize the pump’s security codes for the protocol that is being manually edited. The keypad code, clinician code, and administrator code can all be customized to a unique threedigit number from 001 to 899. If desired, you may customize the codes to be the same; however, upon using that code, the user will be given the highest level of permissions assigned to that code (see the security level table on page 16 for more information). For example, if the keypad code and clinician codes are the same, each time that code is entered the user will be given clinician code permissions. If you choose to allow the cassette/keypad lock to unlock the keypad, it will also be given permissions for all codes that share the same code as the keypad code. To access the security settings, press U or D to choose Security in the administrator settings menu and press S.

** Text omitted from online version **

1. In the Security Settings menu, press U or D to choose Keypad Code and press S.

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** Text omitted from online version ** 1. In the security settings menu, press U or D to choose Clinician Code and press S.

3. Verify the new clinician code by reentering it on the next screen. Press U or D to enter the new code. Press S to advance to the next digit. Once the code has been entered, select Accept Value. Press here to Accept Value

Press here to Accept Value

Clinician Code

2. Press U or D to enter the new clinician code. You may choose any threedigit combination of numbers from 001 to 899. Press S to advance to the next digit. Once the code has been entered, select Accept Value.

Keypad Code

2. Press U or D to enter the new Keypad Code. You may choose any three-digit combination of numbers from 001 to 899. Press S to advance to the next digit. Once the code has been entered, select Accept Value.

3. Verify the new keypad code by reentering it on the next screen. Press U or D to enter the new code. Press S to advance to the next digit. Once the code has been entered, select Accept Value.

Press here to Accept Value

Press here to Accept Value

Security Settings

Administrator Code ** Text omitted from online version ** 1. In the security settings menu, press U or D to choose Admin Code and press S. 2. Press U or D to enter the new administrator code. You may choose any three-digit combination of numbers between 001 to 899. Press S to advance to the next digit. Once the code has been entered, select Accept Value. 3. Verify the new administrator code by reentering it on the next screen. Press U or D to enter the new code. Press S to advance to the next digit. Once the code has been entered, select Accept Value.

2. Press U or D to choose the desired code and select Save.

Press here to Save

Keypad Security The keypad security option allows you to choose whether you want the clinician to have the option to choose between using a code or using the key to unlock the keypad, or whether the clinician should be restricted to using the code only. To select the keypad security: Press here to Accept Value

1. In the security settings menu, press U or D to choose Keypad Security and press S. 2. Press U or D to select “Code Only” or “Code Or Key” and select Save.

Press here to Accept Value Press here to Save

Manual Programming Security The manual programming security option allows you to choose which security code allows access to the manual program protocol. You may choose to use the keypad, clinician, or administrator codes. (See the Operator’s Manual for more information on the manual mode.) To select the code for manual programming: 1. In the security settings menu, press U or D to choose Manual Programming Security and press S. 15

Security Settings

Security Level Table The keypad code should be used by clinicians who need to set up and manage a protocol for a patient. The clinician code will allow access to all the functions the keypad code allows, as well as a clinician bolus. The administrator code will allow access to all functions of the pump and its use should be restricted to the CADD®‑Solis system administrator and certain designees. The administrator code gives the user the ability to change protocol ranges and all settings in the pump. Pump Operations and Programming Stop/Start

Keypad Security Locked

Keypad Security Unlocked

Clinician Security Unlocked

Administrator Security Unlocked

Running

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Reset Reservoir Volume Start PCA Dose

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Change (Titrate) Continuous Rate

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Change (Titrate) PCA Lockout

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Change (Titrate) Max Doses/Hr Pump Tasks

Keypad Security Locked

Keypad Security Unlocked

Clinician Security Unlocked

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Running

Running

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Give Clinician Bolus

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Start New Patient

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Prime Tubing

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Set Time and Date

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Adjust Backlight Intensity

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Adjust Alarm Volume

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View/Clear Reports

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Access Administrator Settings

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Security Level Table Key • Yes No

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Set Time and Date

Set Time and Date The set time and date screen allows you to edit the time and date, as well as to choose a date format. The date format options are Month/Day/Year or Day/Month/Year. The time option should reflect the current time. The pump shows the time of day in 24-hour time according to the pump’s internal clock. The clock is powered by a separate, internal battery which retains the time even when the 4 AA batteries are removed. NOTE: This battery is rechargeable and automatically recharges when the pump is powered on. It may not keep the time and date, after the pump has been powered off for long periods of time, until you turn the pump on and allow the battery to recharge. The time is used to record the time of events in the delivery and event logs, as well as in other reports. The date option should reflect the current date. This feature is used to record the date of events in the delivery and event logs, in other reports, and to determine when the PM reminder alarms will occur. NOTE: Protocol information will remain the same regardless of changing the time and/or date during a patient’s therapy. To access the set time and date feature, press U or D to choose Set Time and Date in the administrator settings menu and press S. To set the current time: 1. Press U or D until Current Time is highlighted and press S.

2. Press U or D to scroll to the correct hour and press S to navigate to the minutes. 3. Press U or D to scroll to the correct minutes and select Save.

Press here to Save

To set the current date: 1. Press U or D until Current Date is highlighted and press S.

2. Press U or D to scroll to the correct month and press S to navigate to the day. 3. Press U or D to scroll to the correct day and press S to navigate to the year. 4. Press U or D to scroll to the correct year and select Save.

Press here to Save

Updating the time and date to daylight savings time. The pump’s time and date will not automatically update during daylight savings. If you live in a geographical area that follows daylight savings time, you will need to manually update the time and date. You may choose to change the time while the pump is currently being used by a patient, or to wait until the patient is finished with therapy. NOTE: If you update the pump’s time while it is being used on a patient, the timestamps in the event and delivery logs will not be updated to reflect daylight savings prior to the change. All events will record the reported time from when the event actually occurred. For your reference, the event log will record the time it was changed.

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Set Time and Date To set the date format: 1. Press U or D until Date Format is highlighted and press S.

2. Press U or D to choose either the Month/Day/Year format or the Day/Month/Year format and select Save.

Press here to Save

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Display and Sound

Display and Sound

Adjust Backlight Intensity

The display and sound menu allows you to adjust various factors such as the intensity of the backlight on the screen, alarm volumes, sound themes, and key beeps. It also allows you to determine if the continuous rate and PCA dose parameters on the home screen should be hidden or shown. Any changes made in the display and sound menu affect only the protocol that is currently displayed. To access the display and sound menu, press U or D to choose Display and Sound in the administrator settings menu and press S.

Home Screen Settings The home screen settings menu allows you to determine if the continuous rate and PCA dose options should be visible to the clinician on the home screen. If the continuous rate and/or PCA dose are not ever going to be used in the protocol, you may choose to hide these options from the clinician’s view on the home screen. 1. In the display and sound settings menu, press U or D to choose Home Screen Settings and press S.

The backlight intensity feature allows you to adjust the backlight intensity within the range of 1 to 10, with 1 being low and 10 being high. NOTE: Increasing the backlight intensity will shorten the battery life. 1. In the display and sound settings menu, press U or D to choose Adjust Backlight Intensity and press S. 2. Press U or D to scroll from 1 to 10. The pump will display the intensity of each number as it appears. Once you have found the desired backlight intensity, select Save.

Press here to Save

Adjust Alarm Volume The adjust alarm volume allows you to determine the volume of the alarms in the protocol. You may choose between 3 volumes: low, medium, and high. NOTE: If a high or medium priority alarm exists for two or more minutes without being acknowledged, the alarm volume will automatically adjust to “High.”

2. To adjust the continuous rate, press U or D until you reach the continuous rate option, press S.

1. In the display and sound settings menu, press U or D to choose Adjust Alarm Volume and press S.

3. Press U or D to choose Show or Hide and select Save (protocol color will change).

2. Press U or D to choose low, medium, or high and select Save.

Continue this process with PCA dose as well. Press here to Save

Press here to Save

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