Alaris

Alaris SE Pump Technical Service Manual Issue 5 June 2016

Technical Service Manual

68 Pages

File Type: PDF

File Size: 2.07 MB

File Name: Alaris - 1000SM00011 - Alaris SE Pump Technical Service Manual Issue 5 June 2016 - 2016-06.pdf

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Page 1

Alaris® SE Pump Technical Service Manual

Alaris® SE Pump

Contents General Information... 5 Introduction... 5 Product Familiarity... 5 Purpose of this Manual... 5 Conventions Used in this Manual... 5 General Precautions... 6 Features of the Pump... 7 Controls and Indicators... 8 Controls... 8 Indicators... 8

Configuration and Calibration... 9 Configuration Procedures... 9 Six Hour rule (Software version 2.79/2.80 only)... 9 Entering Configuration Mode (C1)... 9 Configuration Table... 10 Set to Defaults (C2)... 11 Setting Language (C2)... 11 Setting Regional Settings (C2)...11 Setting Air In Line Threshold (C2)... 11 Profiles (C2)... 12 Maximum Rate (C3)... 12 Computer Link (C3)... 12 Optional Modes (C3)... 12 Optional Features (C3)... 12 KVO Rate (C4)... 12 Monitoring Options (C4)... 13 Audio (C4)... 13 Configuration Name (C4)... 13 Resistance Options (C5)... 13 Pressure Options (C5)... 14 Manual Baseline (C5)... 14 SEC Key Option (C5)... 14 Fixed Drug List (C6)... 14 Transferring settings to another Pump... 15 Learn/Teach Pump procedure (C5)... 15 Diagnostic Mode... 16 Entering Diagnostics Mode... 16 Calibration... 20 Rate Calibration... 20 Pressure Calibration... 22 Battery Refresh Cycle... 24

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Alaris® SE Pump

Preventative Maintenance... 25 Preventative Maintenance... 25 Visual Inspection... 25 Mechanism Visual Check... 25 Recommended Cleaning and Storage... 27 Cleaning the Pump... 27 Storing the Pump...27 Cleaning and storing the Infusion Set... 27 Cleaning the Flow Sensor... 27 Updates... 28 Upgrading firmware... 28 Test Procedures... 29 Battery Test... 29 Functional Alarm Tests... 29 Mechanism Leak Test... 29 Performance Verification Procedure... 30

Troubleshooting... 31 Log Downloads... 31 Introduction... 32 Software Fault Codes... 32 Battery Manager Error Codes... 34 Technical troubleshooting guide... 35 General Fault Diagnosis... 37

Circuit Descriptions... 38 Functional Module Block Diagrams... 38 Single Channel... 38 Dual Channel... 39 Module Overview Functional Description... 40 Introduction... 40 Principle of Operation... 40 Overview... 40

Corrective Maintenance... 43 Access to Pump... 44 Battery... 44 Cases... 45 Rear Case and Subassemblies... 47 Line Filter and PE Stud... 47 Power Supply Unit (PSU) and Heatsink... 48 Pole Clamp... 49 ECD Board and RS232 Board... 50 Speaker and Fan... 51 Front Case and Subassemblies... 52 Main PCB... 52 Display Modules... 53 Mechanism assembly... 54 1000SM00011 Issue 5

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Alaris® SE Pump

Mechanism Seal... 55 Air-In-Line Assembly... 56 Keypads and Labels... 58

Appendix... 60 Disposal... 60 Information on Disposal for Users of Waste Electrical and Electronic Equipment... 60 Information on Disposal in Countries outside the European Union... 60 Battery Removal... 60 Spare Parts Listing... 61 Case Parts... 61 Keypad and Labels... 62 Electronic Parts... 63 Mechanical Parts... 63 Software... 64 Test Equipment...64 Service Contacts... 65 Document History... 66 Software Upgrade Record... 67

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Alaris® SE Pump General Information

1 General Information Introduction The Alaris® SE Pump, hereinafter referred to as Pump, includes the Model 7131 single and Model 7231 dual Infusion Pumps and may be used to deliver a wide variety of fluids over a broad range of infusion rates from multiple fluid container types. The single channel, Model 7131, provides a full range of features in a small, easy to use, linear peristaltic Pump. The dual channel, Model 7231, offers the same features while providing two, independent infusion Pumps in one Pump. The Pump is designed to meet the infusion requirements as specified in the Directions For Use (DFU) for all hospital departments including general wards, critical and intensive care, operating rooms and accident and emergency rooms.

Product Familiarity Ensure that you are fully familiar with the Pump by carefully studying the Directions for Use prior to operation and prior to attempting any repairs or servicing. As part of continuous improvement, product enhancements and changes are introduced from time to time.

Purpose of this Manual This Technical Service Manual shows how to set up, test and maintain the Alaris® SE Pumps. It is intended for use by personnel experienced in medical equipment testing and maintenance procedures. This manual has been prepared for use by qualified service personnel only. CareFusion recommends that all servicing should only be carried out by CareFusion certified service personnel.

It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your CareFusion products. These documents are referenced on www.carefusion.com. Copies can be obtained by contacting your local CareFusion representative.

Conventions Used in this Manual BOLD

Used for Display names, software commands, controls and indicators referenced in this manual, for example, Alarm Indicator, ok, Power key.

'Single quotes'

Used to indicate cross-references made to another section of this manual. For example, see Chapter 2, 'Configuration and Calibration'.

underline

Used to indicate a link to another section within this manual.

Italics

Used to refer to other documents or manuals. For example, refer to the relevant Directions for Use (DFU) for further information. Also used for emphasis, for example, ...if the gap still measures less than... Wherever this symbol is shown a Hints and Tips note is found. These notes provide useful advice or information that may help to perform the task more effectively.

Wherever this symbol is shown an Update note is found. A typical example is drawing attention to a software upgrade that should be confirmed has been installed.

Wherever this symbol is shown an Important note is found. These notes highlight an aspect of test or maintenance that is important to know about.

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Alaris® SE Pump General Information

General Precautions

Y V

Consult accompanying documents: Prior to using this Pump, carefully read the Operating Precautions described in the Directions for Use (DFU). This Pump contains static-sensitive components. Observe strict precautions for the protection of static sensitive components when attempting to repair and service the Pump. An explosion hazard exists if the Pump is used in the presence of flammable anaesthetics. Exercise care to locate the Pump away from any such hazardous sources.

m M

Dangerous Voltage. An electrical shock hazard exists if the casing of the Pump is opened or removed. Refer all servicing to qualified service personnel. This Pump is protected against the effects of high energy radio frequency emissions and is designed to be fail safe if extremely high levels of interference are encountered. Should false alarm conditions be encountered, either remove the source of the interference or regulate the infusion by another appropriate means. If the Pump is dropped, subjected to excessive moisture, humidity or high temperature, or otherwise suspected to have been damaged, remove it from service for inspection by qualified service personnel.

When connected to an external power source, a three-wire (Live, Neutral, Earth) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the Pump should be operated from the battery.

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Alaris® SE Pump General Information

Features of the Pump AC power indicator

Rate Display(s)

RUN HOLD

ml/hr KVO OPT

HLD PRI

A B

RUN HOLD

POWER

Latch

ml/hr

SEC

PRI

SEC

SEC HLD

OPT KVO

OPTIONS

Pumping Mechanism

•

Clear

Enter

Pressure Transducer

Main Display

Air-in-line Detector

Lower Display

Air-in-line Arm Panel Lock Keypad

Flow Sensor Receptacle(s) BB

RS232 Connector Pole Clamp AC Power Connector

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Alaris® SE Pump General Information

Controls and Indicators Controls Symbol

...

Description Numeric Keypad keys - Enters/changes values.

Channel Select keys and indicators - Select channel A or B. Lights to indicate which channel is selected.

A B

Split Screen key - Displays information for both channels when both channels are infusing. Audio Volume key - Sets audio volume for alarms, alerts and KVO tone. Press key to adjust volume. Audio volume level displays in the lower LCD display. • Pump can be configured to enable only Medium and High, or only High audio volume levels.

Clear

Clear key - Clears selected numeric value.

Enter

Enter key - Accepts value or selection entered.

POWER

Power key - Turn channel(s) on and off.

OPTIONS

Options key - Accesses additional features. Silence key - Silences audible alarm or alert for 2 minutes; message remains on screen. New alarm or alert reinstates the audible tone.

PRI

Primary key - Selects Primary mode. Channel must be selected, if applicable.

SEC

Secondary key - Selects Secondary mode. Channel must be selected, if applicable.

RUN HOLD

Run/Hold key - Start and stop infusion on selected channel. Channel must be selected to restart, if applicable. Panel Lock key - Located behind the handle this key helps prevent unauthorised changes to the Pump settings.

Softkeys - Access main display menu options. A soft key is active if there is a tick mark (y) next to the key.

Indicators Symbol

Description

Infusing indicator(s) - Indicates a channel is infusing.

Power indicator - When illuminated Green the Pump is connected to an AC power supply and the battery is being charged. When flashing Amber the Pump is running on the internal battery. Alarm indicator(s) - Indicates a channel is in alarm and has stopped infusing.

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Alaris® SE Pump Configuration and Calibration

2 Configuration and Calibration Configuration Procedures The configuration procedures are for use by qualified service personnel only. The configuration mode is intended for programming the technical and clinical features in accordance with the institution’s current procedures and practices. Pressing a softkey at the side of the main display the first time selects it for editing. Some features are edited by subsequent presses of the softkey to cycle through available options. Other features are edited by means of the numeric keyboard entry. Pressing undo will undo any edits made to that page. Pressing ok will accept all information on the page. Pressing Power key after editing a configurable item will evoke an invalid key tone and a message to ok entry. Any edits must be confirmed before the Pump can be powered off.

Before making any amendments to configuration settings care should be taken to document existing configuration settings to enable changes to be reverted if required. Configuration requirements may vary from ward to ward therefore care should be taken to ensure any configuration settings are appropriate for the ward concerned and users are aware of any changes to configuration settings prior to use. Subsequently, sharing of Alaris® SE Pumps between wards may be inappropriate.

Six Hour rule (Software version 2.79/2.80 only) When pressure or resistance settings are changed for operation, from the default levels, the Pump will remember these new settings. The only way to clear these changed default levels is to leave the Pump off for a minimum of six hours. Changing the settings in the configuration mode will not change these values unless the Pump is turned off for six hours or the Pump settings are again changed during operation.

Entering Configuration Mode (C1) The Pump must be off (both channels must be off for 7231). The procedure is the same for both a single and a dual channel Pump. Any configuration in the dual channel Pump sets the same value for both channels. 1. Press and hold the left-bottom display softkey. 2. Press and release the Power key. Continue to press the display softkey until the Configuration Mode display appears, then release. 3. Page C1 of the Configuration Mode is displayed. This is a read only display. Press page softkey to advance to the page that is to be configured. Note: Page numbers are displayed in the upper right corner of the display.

A B CONFIGURATION MODE C 1 ID No. : 001234567 SW Rev.: 8.53 Config.: 2D15 GOLD

Page number

page

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Alaris® SE Pump Configuration and Calibration

Configuration Table Configurations available vary dependant upon the software version installed. The table below show which configurations are available for each software version. Page C2

Configuration Set to Defaults Language

Software Version(s)

Default

2.79/2.80

4.54

8.53

P P

Settings

English

English, French, Italian, Spanish, Swedish

N. America

N. America, European

English

English, Spanish

English

• Threshold

100mcL (µl)

50, 100, 200, 500mcL (µl)

• Reset

Off

Off, On

• Accumulator

Off, On

Regional Settings • Region

P P

• Language Air In Line

Dose Rate Drugs

Not Available Off

Off, On

999.9ml/h

0.1 to 999.9ml/h

• Mode

Off

Off, Mntr

• Baud Rate

9600

300, 600, 1200, 1800, 2400, 4800, 9600

• Parity

Even

Even, Odd or None

• Loading Dose

Off, On

• Dose Rate

Off, On

• Multi-Step

Off

Off, On

• Multi-Dose

Off

Off, On

• Panel Lock

Off, On

• VTBI

Off, On

• Multi-Dose Alert

Off

Off, On

5.0ml/h

0.1 to 20.0ml/h

• Mode

Pressure

Hi Resist, Resist, Pressure

• Restarts

0 to 9

• Trends

Off, On

• Volumes

Low Med Hi

Low Med Hi, Med Hi, Hi

• Trans.Tones

Off, On

Maximum Rate Computer Link

Optional Modes

Optional Features

P P

Profiles C3

KVO Rate Monitoring Options

Audio

Configuration Name

P P

P P P

P P

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P P P

P P

Maximum 4 characters

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Alaris® SE Pump Configuration and Calibration Page C5

Configuration

Software Version(s)

Learn Teach Resistance Options

Default

2.79/2.80

4.54

8.53

P P P

Settings

• Resist Display

Off, On

• Resist Alert

Off, On

• Default Alert

100%

1 to 100% rounded by Pump to nearest 5%

• Alarm

600mmHg

1 to 600mmHg

Off, On

Adj

Adj, Fix

600mmHg

1 to 600mmHg rounded by Pump to nearest 25mmHg

600mmHg

1 to 600mmHg rounded by Pump to nearest 25mmHg

Off, On

Pressure Options • Pressure Dsply

P P P

• Pressure Alarm • Alarm • Max Press

P P

• Manual Baseline

• Def Alarm

600mmHg

1 to 600mmHg rounded by Pump to nearest 25mmHg

Manual Baseline

P P P P P

Off, On

SEC Key option C6

P P

Learn

P P

Teach Fixed Drug List

Set to Defaults (C2) The Set To Defaults mode programs all configuration items to their default values. 1. Press the Set To Defaults softkey. 2. Press ok to accept the change. Pressing cancel will leave all items set to their previous values.

Setting Language (C2) All operating displays will be in the language selected, except for diagnostic and configuration modes, which will remain in English. 1. Press the Language softkey. 2. Press and release the softkey to select for editing. Press again to cycle through the language choices. 3. Press ok to accept the change.

Setting Regional Settings (C2) All operating displays will be in the language selected, except for diagnostic and configuration modes, which will remain in English. 1. Press the Regional Settings softkey. 2. Press and release the Region softkey to select for editing. Press again to cycle through the region choices. 3. Press and release the Language softkey to select for editing. Press again to cycle through the language choices. 4. Press ok to accept the change.

Setting Air In Line Threshold (C2) The air in line threshold sets the bubble size sensitivity. The Air In Line Reset setting allows the clinician to respond to an Air in Line alarm, assess the clinical significance of the air, and choose whether or not to continue the infusion without removing the air. The reset feature allows only the current bubble to proceed without tripping an alarm. Press the Air In Line softkey. 1. Press and release the Threshold softkey to select for editing. Press again to cycle through 50, 100, 200, and 500mcl(µl). 2. Press and release the Reset softkey to select for editing. Press again to cycle between On and Off. 3. Press and release the Accumulator softkey to select for editing. Press again to cycle between On and Off. 4. Press ok to accept the change.

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Alaris® SE Pump Configuration and Calibration

Profiles (C2) The data set for Guardrails® Safety Software must be loaded to set Profiles to On. For the Guardrails® Safety Software to function, Profiles and Dose Rate must be On. When Profiles is turned on, the configuration mode will have limited access. Access will be limited to Regional Settings, Profiles, Computer Link and Optional Features, due to the data set overriding the configuration settings as part of the Guardrails® Safety Software. 1. Press the Profiles softkey. 2. Press and release the softkey to select for editing. Press again to cycle between On and Off. 3. Press ok to accept the change.

Maximum Rate (C3) This sets the maximum selectable rate. 1. Press the Maximum Rate softkey. 2. Press and release the softkey to select for editing. Use numeric keypad to enter maximum rate. Press Enter. 3. Press ok to accept the change.

Computer Link (C3) The Computer Link feature allows a hospital/facility computer to interact with the Pump and programs the level of computer control available. Monitor Mode allows computer to only receive information from Pump. Off Mode does not allow any communication between Pump and a computer. 1. Press the Computer Link softkey. 2. Press Mode soft key to select for editing. Press again to cycle through Off and Mntr. 3. Press Baud Rate soft key to select for editing. Press again to cycle through choices. 4. Press Parity soft key to select for editing. Press again to cycle through choices. 5. Press ok to accept the change.

Optional Modes (C3) The Optional Modes feature allows the options menu to be configured to how it will appear in normal mode. Enabling of these modes will automatically place them in the option menu. NOTE: Dose Rate must be On in order to use Guardrails® Safety Software drug selection capability. 1. Press the Optional Modes softkey. 2. Press Loading Dose soft key to select for editing. Press again to cycle between On and Off. 3. Press Dose Rate soft key to select for editing. Press again to cycle between On and Off. 4. Press Multi-Step soft key to select for editing. Press again to cycle between On and Off. 5. Press Multi-Dose soft key to select for editing. Press again to cycle between On and Off. 6. Press ok to accept the change.

Optional Features (C3) The Panel Lock feature allows the front panel to be locked and unlocked to help prevent tampering. When VTBI (volume to be infused) is On, a volume to be infused must be entered. When the Multi-Dose Alert feature is On, the option is available to set an alert at the end of every dose when in the Multi-Dose mode. 1. Press the Optional Modes softkey. 2. Press Panel Lock soft key to select for editing. Press again to cycle between On and Off. 3. Press VTBI soft key to select for editing. Press again to cycle between On and Off. 4. Press Multi-Dose Alert soft key to select for editing. Press again to cycle between On and Off. 5. Press ok to accept the change.

KVO Rate (C4) The Pump will automatically operate at the KVO rate (or current rate, whichever is less) once the primary VTBI has counted down to zero. 1. Press the KVO Rate softkey. 2. Press and release the softkey to select for editing. Use numeric keypad to enter maximum rate. Press Enter. 3. Press ok to accept the change.

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Alaris® SE Pump Configuration and Calibration

Monitoring Options (C4) Infusion sets, catheters, and applications create various levels of resistance to flow. Monitoring mode options are available to meet each clinical application, as follows: • Monitoring Options: to select Infusion set/site monitoring modes of resistance, high resistance, and adjustable pressure. • Pressure: highest occlusion method, when set to a default of 600 mmHg, when Resistance and High Resistance modes are not sufficient. • Resistance: designed to monitor Infusion set/site resistance, providing optimum sensitivity. Used for larger catheter sizes, up to 24 gauge. • High Resistance: designed to monitor Infusion set/site resistance, with optimum sensitivity where smaller, higher resistance, catheters, 26 or 28 gauge, are used. • Trend Graphs: display downstream pressure or flow resistance over time. 1. Press the Monitoring Options softkey. 2. Press and release the Mode softkey to select for editing. Press again to cycle between Resist, Hi Resist, and Pressure. 3. Press and release the Restarts softkey to select for editing. Use the numeric keypad to enter the number of restarts then press Enter. 4. Press and release the Trend softkey to select for editing. Press again to cycle between On and Off. 5. Press ok to accept the change.

Audio (C4) The volume settings determine which range of audio volume is available to the clinician. A transition tone, if enabled, will sound upon completion of a secondary VTBI, step in multi-step mode, dose beginning and ending in multi-dose mode, and completion of a loading dose in loading-dose mode. 1. Press the Audio softkey. 2. Press and release the Volumes softkey to select for editing. Press again to cycle between Low/Med/Hi, Med/Hi, or Hi. 3. Press the Trans. Tone softkey to select for editing. Press again to cycle between On and Off. 4. Press ok to accept the change.

Configuration Name (C4) The characters entered here will be shown in the lower LCD display. This electronic label is normally displayed, even when the Pump is off. The configuration name can be used to uniquely identify the Pump’s configuration, hospital location, or reference number. It is a 4 character alphanumeric name, examples are: PICU (Paediatric Intensive Care Unit), ICU (Intensive Care Unit). 1. Press the Configuration Name softkey. 2. Press and release Config.Name softkey to position the highlight on the character to be changed. 3. Press and release the character softkeys aligned with the rows A to M, N to Z, or 0 to _ to highlight the character required. 4. Press enter softkey. Up to four characters can be programmed in this way. Repeat steps 2,3,4 as necessary. 5. Press ok to accept the changes.

Resistance Options (C5) • Resistance Display: provides a bar graph and indication of resistance in the line while monitoring a single channel. • Resistance Alert: provides an early warning of increases in downstream flow resistance by allowing the level to be adjusted in 5% increments during operation. • Default Alert: provides a starting point for occlusion detection if a different level has not been chosen. The selected level will remain in effect while the Pump is on, until another option is selected from the Monitoring Options page. The channel will retain the selected option up to six hours after the Pump is turned off. After six hours the channel will return to the default setting. • Alarm: provides the option to lower the pressure occlusion setting that is still active, even in resistance modes. 1. Press the Resistance options softkey. 2. Press and release the Resist Display softkey to select for editing. Press again to cycle between On and Off. 3. Press and release the Resist Alert softkey to select for editing. Press again to cycle between On and Off. 4. Press and release the Default Alert softkey to select for editing. Enter a number using the keypad, then press ENTER. The Pump will round up or down to the nearest 5% increment. 5. Press and release the Alarm softkey to select for editing. Enter a number using the keypad, then press ENTER. 6. Press ok to accept the change.

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Alaris® SE Pump Configuration and Calibration

Pressure Options (C5) • Pressure Display: provides a bar graph and indication of pressure in the line while monitoring a single channel. • Pressure Alarm: allows the choice of a fixed pressure mode or an adjustable pressure mode. -- Adjustable Pressure: Can provide an early warning of increases in downstream pressure and provide user adjustable pressure alarm limits. -- Fixed Pressure: Provides a warning of increased downstream pressure and alarm, based on a fixed pressure limit of 600 mmHg. • Alarm: provides an adjustable pressure setting in 25 mmHg increments. This acts as the default setting after the Pump has been off for more than six hours and the previous setting was cleared. Pressure Alarm = Adj must be selected to change from 600 mmHg. • Auto Baseline: The Pump reads a baseline at startup and then adds the alarm limit, to determine the point of alarm. For example, if an alarm limit of 300 mmHg was selected, the Pump would alarm at baseline + 300 mmHg. Auto Zeroing occurs the first time RUN HOLD is pressed; this will be the maximum baseline. Subsequent presses of RUN HOLD will only lower the baseline. • Manual Baseline: sets a fixed baseline and overrides the Auto Zero level until the Pump is turned off, the latch is opened, the set is reloaded, or the pressure baseline function is performed again. This allows the Pump to display the actual pressure required for an IV infusion set to infuse. To get this real time readout, Manual Baseline must be On. • Maximum Pressure: provides a maximum pressure setting in 25 mmHg increments. • Default Alarm: provides an adjustable pressure setting in 25 mmHg increments. This acts as the default setting after the Pump has been off for more than six hours and the previous setting was cleared. 1. Press the Pressure Options softkey. 2. Press and release the Pressure Dsply softkey to select for editing. Press again to cycle between On and Off. 3. Press and release the Pressure Alarm softkey to select for editing. Press again to cycle between Adj and Fix. 4. Other options are software dependent: • For Pumps with v2.79 / 2.80 software the options are: -- Press and release the Alarm softkey to select for editing. Enter a number using the keypad, then press ENTER. The Pump will round up or down to the nearest 25 mmHg increment. -- Press and release the Manual Baseline softkey to select for editing. Press again to cycle between On and Off. • For Pumps with v4.54 and v8.53 software the options are: -- Press and release the Max Press softkey to select for editing. Enter a number using the keypad, then press ENTER. The Pump will round up or down to the nearest 25 mmHg increment. -- Press and release the Default Alarm softkey to select for editing. Enter a number using the keypad, then press ENTER. The Pump will round up or down to the nearest 25 mmHg increment. 5. Press ok to accept the change.

Manual Baseline (C5) Note: This option is available for Pumps with v2.79 / 2.80 software under Pressure Options. Note: See Pressure Options for details of this option. 1. Press the Manual Baseline softkey. 2. Press and release the Manual Baseline softkey to select for editing. Press again to cycle between On and Off. 3. Press ok to accept the change.

SEC Key Option (C5) Note: This option is available for Pumps with v8.53 software only. The secondary key option allows the secondary key to be enabled or disabled. 1. Press the SEC Key Option softkey. 2. Press and release the softkey to select for editing. Press again to cycle between On and Off. 3. Press ok to accept the change.

Fixed Drug List (C6) Note: This option is available for Pumps with v8.53 software only. The fixed drug list option allows the factory default Drug List to be turned off or on. When off, no drug names are displayed.secondary key to be enabled or disabled. 1. Press the Fixed Drug List softkey. 2. Press and release the softkey to select for editing. Press again to cycle between On and Off. 3. Press ok to accept the change.

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Alaris® SE Pump Configuration and Calibration

Transferring settings to another Pump Once a Pump has been programmed to meet technical and clinical needs, the settings can be transferred to other Pumps. The programmed Pump is referred to as the Teacher and the other Pump is referred to as the Learner.

Only the configuration settings will be transferred. The Pump ID number, periodic maintenance settings, and other settings from the diagnostics mode will not be transferred. The Guardrails® Safety Software data sets will not be transferred.

Connect a standard 9-pin Null Modem RS232 cable (133450) to the RS232 ports on the Pumps.

Learn/Teach Pump procedure (C5)

The Learn/Teach function will not work if the revision level for Learn/Teach is not the same on both Pumps. It is not recommended to Learn/Teach different model families; such as a model 7130/7230 to Learn/Teach a Model 7131/7231.

1. Access the Configuration Mode for both Teacher and Learner Pumps. 2. Press and release the Teach softkey of the Teacher Pump and press and release the Learn softkey of the Learner Pump. 3. Press and release the start softkey of the Teacher Pump. The Pumps will display Downloading until the transfer is complete and then they will indicate if the transfer was successful or unsuccessful.

• Repeat allows the operator to re-attempt teaching the current Pump or to teach the next Pump. • Reattach the cover, and/or cover and screws, over the RS232 port after disconnecting the cable.

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Alaris® SE Pump Configuration and Calibration

Diagnostic Mode The Diagnostic Mode is used to manage periodic preventive maintenance of the Pump and view the Pump’s history. It allows testing of functions and entry of the Pump’s ID number. Pressing a softkey at the side of the main display the first time selects it for editing. Some features are edited by subsequent presses of the softkey to cycle through available options. Other features are edited by means of the numeric keyboard. Note: Pressing undo or cancel will undo any edits made to that page, and stay on the page. Pressing ok will accept all information on the page, and return to menu page.

Entering Diagnostics Mode The Pump must be off, both channels must be off for the 7231. Though the figures in this procedure depict a single channel Pump, the procedure for the dual channel Pump is the same. Channel specific items will display A or B in upper left corner. 1. Press and hold the left-top display softkey. 2. Press and release Power key. Continue to press the display softkey until the Diagnostic Mode display appears, then release. 3. Page D1 of the Diagnostics Mode is displayed. This is a read only display. Press page softkey to advance to the page you want to configure. Code

Test

Description

Diagnostic Mode

Entering diagnostic mode

PM Setup

Setting preventative maintenance interval

History

Viewing alarm or error history (Event log)

Set Time

Setting time and date

Battery Status

Changing rated capacity of battery

DC Voltages

Viewing DC voltages

Set ID Number

Setting ID number

Run Times

Viewing battery and total run times

Self-Check Timer

Viewing and setting self-check timer

Test A Sensors

Testing A channel sensors.

Cal A Rate

Viewing/changing rate calibration information for channel A

Test B Sensors

Testing B channel sensors.

Cal B Rate

Viewing/changing rate calibration information for channel B

Test Main LCD

Testing main LCD

Test Aux. LCD

Testing auxillary (lower) LCD

Test Switches

Testing switches

Main LCD Contrast

Charging main LCD contrast

Cal A Pressure

Calibrating A channel pressure

DAC A Settings

Factory set

Cal B Pressure

Calibrating B channel pressure

DAC B Settings

Factory set

Pressure System

Set auto zero on or off

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Alaris® SE Pump Configuration and Calibration

Setting Preventive Maintenance Interval (D2) The preventive maintenance reminder is a message that appears upon start-up, telling the clinician that the maintenance cycle has elapsed. The clinician may choose to bypass the message and operate the Pump as normal. The reminder will continue to appear at startup until it is reset. 1. Press the PM Setup softkey. 2. Press and release the PM Reminder softkey to cycle between On and Off. 3. Press the PM Interval softkey. 4. Use the numeric keypad to enter the desired maintenance interval (1 to 52 weeks). Press Enter key. 5. Press ok to accept the change. Press Undo to reinstate previous values.

Note: PM Due decrements with calendar time and is displayed to the nearest week. Pressing the Reset PM Due softkey resets the PM Due to the displayed PM Interval..

Viewing Alarm or Error History (Event Log) (D2) The History Log will keep 2000 entries to the Pump in memory. Entry 0001 will be the most recent and entry 2000 will be the oldest. No more events will be displayed if less than 2000 events are recorded. Note: The History Log will only store 1300 entries for software version 8.53.

1. Press the History softkey. 2. Pressing the page softkey will scroll forwards and backwards to the next event screen. Events are listed on a last in, first out basis. 3. Press return softkey when finished viewing.

Note: For mode/state changes the first line will say Misc. Inst. (Miscellaneous Instruction). Key Inst will be displayed to indicate a key/switch activation. Alarms and errors may be channel specific or Pump related, this will also appear on the first line. The second line will give you the month, day, year, hour and minute the entry/event took place. The third line will show the event/entry that occurred.

Setting time and date (D2) 1. Press the Set Time softkey. 2. Press Month softkey to highlight. Press Month softkey as needed to get desired month or enter number value of month on keypad and press Enter key. Note: Method for entering Month will depend upon the software version installed. 3. Press Date softkey to highlight. Enter date on keypad and press Enter key. 4. Press Year softkey to highlight. Enter year on keypad and press Enter key. 5. Press Time softkey to highlight hours, 24 hour display. Enter hour on keypad and press Enter key. To change minutes, press Time softkey again to highlight minutes. Enter minutes on keypad and press Enter key. 6. Press ok to accept the change. Press the Undo softkey to reinstate time/date.

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Note: The software clock may lose up to 3 minutes per month. Reset the time as part of Preventive Maintenance or more often as desired. When the clock is reset for current time/date the previous logs will not be adjusted retroactively. The clock will not automatically adjust for time changes such as daylight savings. The internal clock operation is powered by the battery. The clock stops when battery voltage reaches 11.45V and is reset at <11.45V.

Alaris® SE Pump Configuration and Calibration

Changing rated capacity of battery (D2) This step is only required if a different type or different capacity battery is later approved for use. As long as the battery is NiCad and rated at 1.8 Ah, no action is required.

Battery is rated at 1.8 Ah under ideal conditions. 1.3 Ah must be entered here to help compensate for uneven cell capacity and ensure getting a Low Battery alarm with 30 minutes or more use on battery.

1. Press and release the Battery Status softkey. 2. Press and release the Rated Capacity softkey to highlight. 3. Use the numeric key pad to enter the rated capacity of the new battery. Press Enter key. 4. Press ok to accept the change.

Viewing DC voltages (D3) 1. Press the DC Voltages softkey. 2. Press the return softkey when finished viewing.

Setting ID number (D3) An ID number may be useful for asset tracking, maintenance records, etc. 1. Press the Set ID Number softkey. 2. Press bottom-left softkey to highlight. 3. Use the numeric key pad to enter the desired identification number. Press Enter key. 4. Press ok to accept the change.

Viewing battery and total run times (D3) 1. Press the Run Times softkey. 2. Press the Clear Battery Time softkey to clear battery run time. Note: Total run time will not clear. 3. Press ok to accept the change.

Viewing self-check timer (D3) The self-check timer is an interval at which the software checks the pressure sensor offset drift when it can be determined a set is not loaded and no other external forces are being applied to the pressure sensor. This periodic check ensures the set can be sensed as it is installed and removed. The Pump will ask the operator to remove the set before powering down. 1. Press the Self-Check Timer softkey. 2. Verify interval is set to 12 weeks. 3. Press ok to accept the change.

Testing channel sensors (D4) 1. Press Test A Sensors or Test B Sensors softkey (dual channel Pump). The display will show D4A or D4B depending on which channel was selected. • M Flag reads Light or Dark, Dark with 5th cam in. • Latch reads Open or Closed. • AIL reads Air or Fluid. • ECD reads: Not Installed

ECD board assembly not installed.

Unplugged

ECD board assembly installed. Flow sensor not connected

Air

ECD board assembly installed. Flow sensor detects air.

Fluid

ECD board assembly installed. Flow sensor detects fluid.

2. Press the return softkey to return to the D4 page.

Viewing/changing rate calibration information (D4) This page is for viewing only. Use the following procedure to view or change the rate Cal # setting. 1. Press Cal A Rate or Cal B Rate softkey depending on which channel is to be viewed. 2. To change the Rate Cal # (%) press upper left softkey two times. The Pump will beep, but the display will not change. 3. Press Cal # softkey to highlight and select for editing. 4. Change Cal # based on results of calibration rate run. 5. Press Enter key then ok to accept the change or press undo to return to old Cal number. Note: The Cal# can not be changed from one non 0 number to another non 0 number with out first running the Pump for 2 seconds. 1000SM00011 Issue 5

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Alaris® SE Pump Configuration and Calibration

Testing Main LCD (D5) 1. Press the Test Main LCD softkey. The test consists of the Main LCD alternating between normal and reverse video every 2 seconds. All LEDs also flash on and off at a 2 second rate. 2. Press the return softkey to return to the D5 page.

Testing Aux (lower) LCD (D5) 1. Press the Test Aux. LCD softkey. This tests the Lower LCD Display, lighting all segments of the display. 2. Press the return softkey to return to the D5 page.

Testing switches (D5) 1. Press the Test Switches softkey. 2. Proceed to press all keys on the Pump. As you press a key, the key’s name will appear. Proper functionality of the return softkey is tested only by the key performing its function; i.e., returning the LCD to the D5 page. Note: Keylock key should be included when testing switches. When the Power key is pressed, it will display Press and hold key to turn off. 3. Press the return softkey to return to the D5 page.

Changing Main LCD contrast (D5) 1. Press the Main LCD Contrast softkey. 2. Press the softkey next to the contrast number to highlight. 3. Use the numeric key pad to enter the desired LCD contrast,the contrast range is 1 to 256. Press Enter key. Note: Decreasing number lightens contrast. LCD will be fully dark or light if set to 1 or 256. 4. Press ok to accept the changes and undo to return to previous setting.

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Alaris® SE Pump Configuration and Calibration

Calibration Rate Calibration 1. Change Cal # to 0.0 to run rate calibration and calculate a new calibration number. NOTE: Once the Rate Cal # is set to 0.0 and accepted, the Pump will need to be run for at least two seconds before the Rate Cal # can be changed to a nonzero value. If not, the Pump will display Do Rate Accuracy Test at 0%. The Pump will not allow one nonzero value to be changed to another nonzero value. NOTE: Rate Calibration is run at the nominal value, 0.0%, so that the percentage can be directly entered in the Pump without another calculation. NOTE: Keep track of the number of times the 80VCS calibration set is used. Calibration set should be used for only 30 infusions. 2. Set up equipment as shown in figure 1. Water Source

Burette (50 ml)

30 ±1 inches

Burette Clamp

KVO OPT

RUN HOLD

A B

Equipment Stand

1 4

ITI

RUN HOLD

POWER

HLD PRI

SEC

PRI

SEC

SEC HLD

OPT KVO

OPTIONS

•

Clear

Enter

™

1 2 3 4 hr s

80VCS Rate Cal Set Tubing

Table or Bench

Instrument Stand

Three-Way Stopcock

IV Tubing Used Fluid Receptacle

Figure 1 - Rate Calibration / Verification Set up 3. Load primed calibration set into Pump and close the latch. Verify there is no fluid flow or drops falling in drip chamber. 4. Set stopcock to output into a class A or B burette. 5. Plug Pump into AC power. Press Power key to turn channel on. 6. Ensure Pump, both channels if dual channel, is set to Pressure mode. 7. Adjust fluid level in burette until meniscus is level with zero mark on burette. 8. Verify primary infusion rate is 400 ml/h. 9. Set VTBI to 40 ml and clear volume infused. 10. Press Run/Hold to start primary infusion. 11. Pump will run approximately 360 seconds to complete delivery and then go into KVO mode. Stop Pump within 1 second of its entering KVO mode. 12. Make a note of volume collected in burette and note expected volume, as identified on 80VCS calibration set insert. Note: Do not remove 80VCS set from Pump until one of following is determined: • Pump has passed rate verification and calibration is not needed. • Rate calibration number was changed and Pump now passes verification. • Mechanism replacement is required. 13. Calculate volume accuracy as follows: • Vcollected = volume in burette in ml • Vexpected = characterized volume printed on 80VCS set insert a) A = Vcollected / Vexpected b) B = A x 100 c) % Error (Round % Error to nearest tenth of a percent.) = B - 100 1000SM00011 Issue 5

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