Sigma Spectrum Operators Manual RevT Nov 07

CONTENTS REMOVE FROM THE SHIPPING BOX ... 4 KEY OPERATING TIPS... 5 BACKGROUND INFORMATION... 6 Intended Device Use ... 6 System Components ... 6 Cautions and Warnings ... 6 SYMBOLS ... 7 ILLUSTRATIONS ... 8 Front View – Door Open... 8 Front View – Pump Running with Standard Battery ... 9 Front View – Pump Running with Wireless Battery Module... 10 Back View- With Standard Battery ... 11 Back View- With Wireless Battery Module ... 12 SETUP AND OPERATION ... 13 Keys ... 13 Pre-Pump Programming... 13 AC Power Adaptor ... 14 Set Loading (Unloading)... 14 Drug Error Prevention Programming... 15 Dose Rate Limits ... 15 Basic (mL/hr) Programming... 15 Secondary Infusion ... 16 Reviewing/Reprogramming a Depleted Secondary Infusion... 17 Manual Programming Mode ... 17 Titrating... 18 Patency Checks... 18 Keypad Lock Operation ... 18 Pump Standby (Hold Mode) ... 19 Delayed Start ... 19 ALARMS ... 21 Air-in-Line ... 21 Audio... 21 Depleted Battery... 21 Door Not Fully Closed / Set Outside Channel ... 21 Door Open ... 21 Downstream Occlusion... 21 Infusion Complete... 21 Inactive Alarm ... 21 In Stop – Load Set ... 21 In Stop – Open Slide Clamp ... 21 In Stop – Push Run ... 21 Low Battery... 22 Very Low Battery ... 22 Battery Missing ... 22 Shut Door... 22 Slide Clamp Closed ... 22 System Error... 22 Upstream Occlusion ... 22 TIPS... 23 Prevent Nuisance Alarms ... 23 Managing Bolus before Occlusion (Downstream) Release... 23 WARNINGS AND CAUTIONS ... 24 CLEANING AND STORAGE ... 28

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Storing ... 28 Battery Disposal ... 29 Battery Charging... 29 Battery Removal and Replacement... 29 SERVICING ... 30 To Return Pumps to SIGMA... 30 Required Maintenance and Frequency ... 30 ACCESSORIES ... 31 Accessories ... 31 SIGMA IV SETS ... 33 COMPATIBLE IV SETS ... 34 LIMITED WARRANTY ... 36 Appendix A... 38 SPECIFICATIONS ... 39 Pump Options ... 39 Master Drug Library (MDL)... 39 Drug Library Transfer ... 39 Infusion Modes ... 39 Standard Gravity IV Sets ... 39 Size and Weight ... 39 Battery ... 40 Pump Characteristics and Flow Rate Accuracy ... 40 Wireless Network Interface... 40 Wireless Security... 40 Environmental Limits ... 40 Display ... 41 Alarms and Alerts ... 41 Timekeeping ... 41 Logging Memory... 41 AC Power... 41 External Interfaces... 42 Standards ... 42 FLOW RATE ACCURACY... 43 1, 2 Effect of Fluid Container Height ... 43 1 Effect of Back Pressure ... 43 Effect of Temperature... 43 Flow Profile ... 43 BOLUS ACCURACY ... 49 DOWNSTREAM OCCLUSION ... 49 Time to Occlusion ... 49 Bolus Volume... 49 ELECTROMAGNETIC COMPATIBILITY ... 50 Emissions... 50 Immunity – ESD, transient/burst, voltage disparity, magnetic ... 51 Immunity – Conducted and Radiated... 52 Immunity – Separation Distances ... 53 Appendix B... 54 Low / Very Low Battery Tutorial... 55 Appendix C... 58 Power Icons... 59 Wireless icons ... 60

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REMOVE FROM THE SHIPPING BOX The SIGMA Spectrum has been packaged to provide protection during transportation and storage. Remove the Spectrum from the protective anti-static bag and remove the protecting foam end caps. Discard the desiccant package. The battery tab has been provided to isolate the battery voltage from the pump during transport and distribution. Remove the battery insulating tab prior to charging the pump’s battery or operating the pump. This is accomplished by pulling the tab straight out from the Battery Pack mounting cavity.

Pull the battery tab straight out from the Battery Pack cavity.

> It is suggested that all packaging materials be saved for reuse. This is advised in the event product repair or warranty replacement is necessary. > It is strongly recommended that the pump’s battery be fully charged (12 hour minimum) before depending on the battery as a source of pump power.

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KEY OPERATING TIPS 1. FOLLOW ALL PROMPTS. 2. LOAD SETS PROPERLY. To open the pump door, push the gravity IV set’s slide clamp fully into the keyhole. Load tubing tautly, from top to bottom in loading points 1, 2, 3 and 4, following the red/green prompts. Push the door closed in the two door hook areas. Open the slide clamp by pulling it straight up, while holding the tubing around it down. 3. USE THE DRUG ERROR PREVENTION SYSTEM. DEP mode protects against human errors that could cause Adverse Drug Events. BASIC mode can not detect human errors. 4. DO NOT DROP THE POWER SUPPLY. The power supply is an electronic device. It is not simply a plug, and it will break if repeatedly dropped. 5. FOLLOW SECONDARY PROCEDURES Use SIGMA metal hooks to drop primary containers below secondary containers. With secondary rates above 300 mL/hr, look for and clamp off primary line siphoning.

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BACKGROUND INFORMATION Intended Device Use The SIGMA Spectrum is a multifunctional, intravenous and epidural, drug error prevention (DEP) “smart” infusion pump. It is intended for infusion applications in hospitals, outpatient care areas and homecare services.

System Components SIGMA Spectrum Pump:

Standard gravity IV sets:

with slide clamp

Fig 1

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(Required for door opening)

Fig 2

Master Drug Library (MDL) The MDL is a software tool used by pharmacy to list every IV and epidural drug found in the pharmacy’s formulary, along with associated care areas and infusion parameters for each drug entry.

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MDL Transfer Accomplished by: Transfer from a wireless network connection to a pump using a wireless battery module • Transfer from the PC to a mobile PDA and then transfer by infrared from the PDA to a pump •

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SIGMA Spectrum Infusion Pump (Fig 1)

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Standard Gravity IV Sets (containing a slide clamp used for door opening) (Fig 2)

Cautions and Warnings For other essential conditions of use, general warnings and operator preparation see “SETUP AND OPERATION”, “ALARMS” and “CAUTIONS and WARNINGS” section in this manual

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SYMBOLS

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Attention, consult ACCOMPANYING DOCUMENTS

CLASS II EQUIPMENT

TYPE BF APPLIED PART Direct current ON (only for part of the EQUIPMENT) OFF (only for part of the EQUIPMENT)

* Note: to completely disconnect the equipment from the external power, unplug the AC Power Adaptor from the mains receptacle. Recyclable, dispose of properly

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These symbols are on the Battery Pack and are used to identify polarity of the battery. This is for reference only.

This is a representation of the Direction of Flow label (not to scale). This label appears behind the door of the pump. It is intended to assist the user in determining the direction of fluid flow from the medication container to the patient. The fluid direction is controlled by the pumping mechanism when the door is closed and the pump is in the infusion mode (running).

Non-ionizing electromagnetic radiation

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ILLUSTRATIONS Front View – Door Open

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Front View – Pump Running with Standard Battery

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Front View – Pump Running with Wireless Battery Module

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Back View- With Standard Battery

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Back View- With Wireless Battery Module

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SETUP AND OPERATION Keys -

SOFT KEYS (the top row of keys on the keypad) are non-labeled keys with various functions depending on what is displayed above them.

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ARROWS advance cursors and select alternate choices.

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HELP selects photo instructions for things such as door opening / set loading.

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OK confirms entries and advances cursors.

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SETUP starts programming.

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LETTERS are selected by pushing corresponding numerical keys once, twice or three times quickly.

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BASIC allows selection of mL/hr setup (bypassing the Drug Error Prevention system). From BASIC, dose rate modes and ramp/taper modes may also be selected.

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CLEAR erases the highlighted entry.

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CLR ALL erases the entire pump set up screen.

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SILENCE quiets the audio alarm for 2 minutes. Additionally, any key can be pushed for silence.

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HOLD places the pump in standby mode.

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ON/OFF turns the pump on or off.

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RUN/STOP starts and stops the infusion.

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OPTIONS allow the user to select additional pump features.

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BACK allows the user to go back.

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RESET resets Manual Programming Mode to Step 1.

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RAMP allows access to the Manual Programming Mode.

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CLR STEP clears one step of Manual Programming Mode.

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TITRATE allows flow rate changes without stopping the pump.

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BOLUS allows Bolus Setup without stopping the pump.

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REVIEW pulls up the set up screen without stopping the pump.

Pre-Pump Programming -

MOUNT THE PUMP to an IV pole.

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Plug the pump into a wall outlet if available.

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IV SETS: select only IV sets made by the manufacturer listed on top of the pump. IV sets must be of standard stiffness and diameter. Performance can not be achieved using stiff, large or small diameter tubing. Contact SIGMA for compatible standard IV set lists and for special SIGMA blood, nitroglycerin and lipid sets. PUMPED-ON TUBING should not be re-loaded into the pumping channel (to avoid nuisance alarms and to maintain flow rate accuracy). NOTE: Flow Rate accuracy will be maintained if the set has been pumped on for no more than 72 hours for Hospira and 96 hours for Baxter IV sets at rate settings not greater than 125 mL/hr, or for total volumes of not more than 9 liters (Hospira) or 12 liters (Baxter). PREPARE IV CONTAINERS AND PRIME IV SETS by positioning roller clamps below the pump, positioning slide clamp near the keyhole at the top of the pump, inverting bags that need to be mixed (rather than shaking them), warming IV solutions to room temperature before use, filling drip chambers approximately halfway and using standard gravity IV set priming technique to purge air from sets and all Y sites.

AC Power Adaptor WARNING USE ONLY THE POWER ADAPTOR SPECIFIED FOR THIS EQUIPMENT. USE OF OTHER POWER ADAPTORS MAY CAUSE PERSONAL INJURY OR DAMAGE TO EQUIPMENT. The power adaptor is used to charge the pump’s battery. The power adaptor uses a locking cord connection to prevent inadvertent disconnection. To engage the power adaptor, align the arrow of the power adaptor cord with the arrow on the connector identified as the external power adaptor connection (on the back of the SIGMA Spectrum pump). Insert the power adaptor module into the appropriate wall power outlet. The Spectrum will display a plug symbol if the power adaptor is working properly when the pump is in operation. The green led on the power adaptor should be on when the adaptor is plugged into a powered wall outlet. NOTE: IMPROPER REMOVAL MAY DAMAGE THE POWER ADAPTOR. Remove the power adaptor cord connection from the SIGMA Spectrum by pulling back the external power adaptor’s shell. This will unlock the connection and removal is accomplished by simply pulling on the connector with the shell retracted away from the back of the pump. Improper twisting or pulling of the connector or cable may damage the power supply. NOTE: Repeated drops of power adaptors on floors will cause them to malfunction. As with all electronic devices, drops should always be prevented. Set Loading (Unloading) WARNING THE PUMP WILL INDEX WHEN THE SET’S SLIDE CLAMP IS REMOVED FROM THE PUMP’S KEYHOLE. THIS WILL PROPEL FLUID (MAXIMUM OF .1ML) IN THE IV SET IN THE DIRECTION OF FLOW AND POSSIBLY TO THE PATIENT. THIS WILL OCCUR IF THE ADMINISTRATION SET IS LOADED IN THE PUMP AND A PATIENT IS CONNECTED TO THE ADMINISTRATION SET. -

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OPEN THE PUMP DOOR by inserting the slide clamp into the keyhole (loading point # 1) and pressing down until the door opens. LOAD IV SET TUBING INTO THE TUBING CHANNEL. Loading must be from the top to bottom of the tubing channel and the tubing should be taught. Load the tubing # # # into loading point 2 and then loading points 3 and 4. CLOSE THE DOOR by pressing the upper and lower corners near the door hooks areas.

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OPEN THE SLIDE AND ROLLER CLAMP.

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TO UNLOAD SETS, push the slide clamp in the keyhole until the door opens and pull tubing out from the bottom of the pump towards the top.

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PREVENT FREE FLOW whenever the pump door is open and when the set is out of the pump. This is accomplished by having the set’s slide clamp or roller clamp fully closed or by partially opening the roller clamp to achieve gravity flow. WHEN CHANGING IV SETS OR CONTAINERS always keep the set’s slide clamp or roller clamp fully closed, (except when following standard gravity set priming procedures).

Drug Error Prevention Programming -

Turn the pump ON.

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Select the care area (nursing area). Push OK.

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Type the drug’s first two letters (all drugs beginning with those two letters will appear). Push OK. Scroll to the desired drug. Push OK

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Select the correct drug concentration (if more than one is offered). Push OK. If the “Concentration Confirmation” option is enabled, a dialog shall appear prompting confirmation of the selected drug concentration. Press “yes” to continue or “no” to reselect. Note that the confirmation dialog will appear only when selecting from a list of concentrations or if entering a concentration manually to a drug that has been assigned a “variable” concentration in the Master Drug Library (MDL). When the setup screen appears: • Confirm the drug and concentration is correct. 1 • Select primary or secondary bag and push OK . • Enter all required data. Push OK after each entry. 1

The bag selection prompt shall not be offered if the selected drug has been specifically assigned to either the primary or secondary bag in the MDL. -

Push RUN to begin the infusion. Confirm that all infusion parameters are as intended.

Dose Rate Limits -

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SOFT DOSE RATE LIMITS may be exceeded by pushing OK twice (once to enter the value and again to accept the limit warning) thereby providing a double confirmation. HARD DOSE LIMITS can not be exceeded. Reset rates within HARD limits to start the pump.

Basic (mL/hr) Programming -

Turn the pump ON.

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Push BASIC.

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If the prior setup needs to be erased, push CLEAR ALL. When the BASIC screen is displayed: Select primary or secondary bag. Push OK. Select mL/hr or use ARROW soft keys to scroll through dose rates. Push OK. Enter the flow rate value. Push OK. Enter the VTBI (Volume To Be Infused) in mL. Push OK. Confirm the computed infusion time. Confirm the Volume Given mL value (or push CLEAR to erase it). Note: VTBI counts down to zero, while VOLUME GIVEN counts from zero up.

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Push RUN to begin the infusion.

Secondary Infusion -

Prepare primary and secondary bags and IV sets (see “Secondary Infusions” under HELP for photo instructions). • Use a primary set with an upper Y site and back check valve. • Connect the secondary set to the primary set’s upper Y site. • Using the metal extension hook supplied by SIGMA, lower the primary bag approximately 20 inches below the secondary bag to provide the secondary bag with a gravity advantage. This causes the primary set’s back check valve to close, which ensures secondary flow. When the secondary bag empties, the primary back check valve opens and primary fluid begins to flow.

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Program the pump for the primary bag as described above.

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Then push SETUP to begin programming the secondary bag.

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If a drug is to be delivered in the secondary program (drug must be pharmacy / hospital-approved for delivery as a secondary line), enter the drug name by typing the drug’s first two letters. Scroll to the desired drug. Push OK. Otherwise push BASIC and use the soft key ▲▼ to change the bag to “Secondary”. Press “OK” and select mL/hr or dose rate mode. When the setup screen appears: • Confirm the drug and concentrations are correct (if selected). • Select secondary bag (using the soft arrow keys). - A “watermark” indicator will be displayed beneath the parameter data to help distinguish the Secondary (2) setup screen from the Primary (1) setup screen. - Note that this watermark shall not appear on Primary-only infusions. • Enter all required data. Push OK after each entry. • To avoid infusing residual amounts of the secondary container at primary flow rates, be sure to properly set the secondary VTBI value. Push RUN to begin the secondary infusion. Scrolling run screens and/or a “two bag” icon denote the secondary is running.

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Open the secondary set’s roller clamp when prompted. Push OK again to confirm accomplishment of that step and begin delivery. If the secondary rate is above 300 mL/hr, a dialog box appears prompting observation of the primary drip chamber.

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If drops are seen, the primary line should be clamped closed. Press “yes” in this dialog box if a clamp is being applied to the primary line. Upon completion of the secondary infusion, the pump will enter a KVO state and it will ask for the removal of the clamp from the primary line. Push OK once the clamp has been removed to clear the alert and begin the primary delivery. Press “no” in the dialog if drops are not observed in the primary drip chamber.

Upon completion of the secondary infusion, transition to the primary infusion shall be automatic and a “one bag” icon shall replace the “two bag” icon on the RUN screen. •

Note: Upon completion of the secondary infusion, the clamp on the secondary set should be closed to prevent any remaining fluid in the secondary bag being delivered at the primary delivery rate.

Reviewing/Reprogramming a Depleted Secondary Infusion -

Once a secondary infusion has completed, its setup parameters may be reviewed by pressing the “review” softkey, moving the cursor to the bag selection parameter and pressing either arrow softkey to select “Secondary Bag”. Pressing OK while viewing “Secondary Bag”, with pump in stop, will repopulate secondary bag setup parameters from the Drug Library. •

Note: Secondary bag setup parameters will not repopulate prior to completion of previous secondary infusion.

Manual Programming Mode -

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The Manual Programming Mode allows the pump to be programmed with up to 10 individual infusion steps using either the Drug Error Prevention or Basic Programming Operations. Drugs are eligible for use in the Manual Programming Mode, provided that the selected drug has not been specifically assigned to either the primary or secondary bag as identified in the pump’s Master Drug Library. Initial programming is similar to the descriptions for Basic or Dose Error Prevention (SETUP) modes. At the primary bag selection of the programming, the RAMP soft key will be displayed allowing access into the Manual Program Mode. Press RAMP to enter Manual Program Mode. •

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Note that Manual Program Mode is not available in Secondary Bag or in Primary Bag when a secondary program exists in memory.

With Manual Program Mode entered, setup again continues as described in the Basic or Dose Error Prevention programming sections. A step indicator bar is located at the top of the screen. The bar shows which steps within the program have parameter data (a small white highlight) and which step is currently being viewed (a full white highlight) Once setup of an individual step has been completed, press OK to advance and th program the next step. When the 10 step has been programmed, the program schedule is complete and no more steps may be programmed. Only one step is necessary to start a program however it must be the first and only programmed step. The pump may not be started if setup data is missing from any

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step in the program. Any parameter data missing within the program shall be identified in a popup message when a program attempts to be started. -

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The setup data for any programmed step may be viewed by moving the highlight (using the up ARROW soft key) to the step indicator bar located at the top of the setup screen and then using the left and right ARROW soft keys to move from step to step. • Note that a one-second delay exists from the time a step is selected and when its setup data is displayed. This delay is to allow rapid scrolling along the step bar without updating the screen contents repeatedly and unnecessarily. • If the pump is stopped, any setup data may be changed by navigating to that step and pressing OK to move to the values that must be changed. It the pump is running, any programmed step may be viewed by pressing the REVIEW soft key but no values may be changed with the exception of the Volume Given value which may be cleared by pressing the CLEAR soft key. Push RUN to start the program. • RUN screens appear as described in the mL/hr or Dose Error Prevention programming sections with the addition of a program step indicator shown in the “Step x of y” format, where x is the current step being delivered and y is the total number of programmed steps. • When the program completes and the STOP key is pressed, the program schedule automatically resets (Note: Always verify current program parameters for each step prior to starting a new infusion) itself and may be restarted without entering/reentering any setup data. The program will be retained indefinitely during power off cycles until reset. To reset the program push the RESET soft key from the PROGRAM STOPPED screen. To clear the entire program, press the CLR ALL soft key and answer YES to the confirmation screen. To clear the setup data from any individual step, the pump must be stopped. Move the highlight to the desired step in the step bar and press the CLR STEP soft key. Note that clearing a step does not delete that step unless it is the last step in the program.

Titrating -

To titrate flow rates without stopping the pump (not available in Program Modes): • Push TITRATE. • Observing the displayed hard and soft rate limits, enter a new flow rate. • Push either RUN or OK.

Patency Checks -

To confirm the IV line is not blocked: • Push STOP. • Open the door. • Slowly open the slide (or roller) clamp to check for gravity flow. If gravity flow can not be achieved, a clamp is closed, the tubing is kinked, the catheter is blocked or a filter may be clogged.

Keypad Lock Operation -

To lock the keypad the caregiver should enter the code 429 (“K”, “E”, “Y”). This code is entered when the pump is in the run mode to prevent unauthorized activation of

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specific key entries. A popup message shall be displayed briefly indicating the keypad has been locked. The Key lock icon is shown on the top left corner of the screen. The REVIEW soft key may be pressed to allow review of the infusion setup data. No values may be changed and therefore navigation from value to value is not allowed when the keypad is locked. The keypad will allow certain alarm conditions to be silenced and cleared while in the Keypad Lock mode. The code must be re-entered to unlock the Keypad. If the keypad is unlocked while reviewing the setup data and the pump is running, as long as the pump is not stopped the keypad will automatically relock upon return to the RUN screen.

Pump Standby (Hold Mode) -

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The pump may be placed in a standby state to prevent the occurrence of the Inactivity Alarm (see ALARMS) for the period of time specified in the User Settings / Alarm Settings menu option. The default setting is to provide an infinite period of time however this value may be changed from one minute up to 99 hours and 59 minutes. For Standby Mode to be available the set must be loaded and the infusion setup must be complete. Once setup has been completed and the highlight is on the Volume Given mL value, a display will appear stating that the pump may either be started or it may be placed in standby mode. To place the pump in standby, press the HOLD soft key. When standby is activated, the indicated message will be displayed in a flashing format. Note that if the delay period is set to infinite, the time value in the display will be replaced with a dashed line.

IN STANDBY 01:00 (hr:min) Push RUN to start pump

While in standby, the user may press RUN at any time to begin the infusion. Pressing any other key or opening the pump door will cancel standby mode. Pump Standby may also be used when the pump is stopped in a non-alarm condition. Press the REVIEW soft key and then press the HOLD soft key from the SETUP screen.

Delayed Start -

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The start of any programmed infusion may be delayed by up to 12 hours. During infusion setup, move the highlight to the Volume Given mL value at the bottom of the list - the D. RUN soft key shall appear, replacing the DOWN ARROW soft key. Pressing the D. RUN soft key shall cause the Delay time value parameter line to appear on the setup screen. Enter any value between one minute and twelve hours (00:01 – 12:00, hr:min) and press OK. •

Note: leaving the Delay time value clear and pressing OK or navigating away from it via an ARROW soft key will cause the parameter line to be removed from the display for the duration of the currently programmed infusion. The D.RUN softkey must be pressed again to display the delay time parameter.

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Once a delay time is entered the infusion program completed and the set is loaded, the RUN key may be pressed to begin the infusion delay timer. The screen shall update to a DELAY RUNNING display with the remaining delay time shown in a flashing format. While the delay is running it may be stopped by pressing the STOP key (display updates to DELAY STOPPED and the delay timer is paused and no longer flashes) or it may be cancelled by pressing the CANCEL soft key (remaining delay time is cleared and the display updates to PUMP STOPPED). The remaining delay time value may be changed while the delay is running or stopped. From the setup screen (press REVIEW if the delay is running) move the cursor to the Delay value and enter the new desired delay time and press OK. The new delay time shall be immediately observed. •

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Note: the Delay time value may not be cleared while the delay is running.

When the delay time period expires, the pump shall begin delivery of the programmed infusion.

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