Sigma Spectrum Operators Manual Rev AL Aug 2009

CONTENTS REMOVE FROM THE SHIPPING BOX ... 5 KEY OPERATING TIPS... 6 BACKGROUND INFORMATION... 7 Intended Device Use ... 7 System Components ... 8 Cautions and Warnings ... 8 SYMBOLS ... 9 ILLUSTRATIONS ... 10 Front View – Door Open... 10 Front View – Pump Running with Standard Battery ... 11 Front View – Pump Running with Wireless Battery Module... 12 Back View- With Standard Battery ... 13 Back View- With 802.11b Wireless Battery Module (P/N 35083)... 14 Back View- With 802.11b/g Wireless Battery Module (P/N 35162)... 15 SETUP AND OPERATION ... 16 Keys ... 16 Pre-Pump Programming... 17 AC Power Adaptor ... 17 Set Loading (Unloading)... 18 Drug Error Prevention Programming... 18 SW V5.02.03 and earlier versions... 20 SW V 6.01 and later ... 20 Dose Rate Limits ... 20 Basic Programming ... 20 Secondary Infusion ... 21 Loading Dose Programming (SW V6.01 and later) ... 23 Manual /Multi-Step: (Ramp soft key- SW 5.02.03 and earlier), (Multi-Step soft key- SW 6.02 and later) Programming Mode ... 24 Cyclic TPN Mode – Software Version 6.02 and Later... 25 Titrating – Software version 5.02.03 and earlier... 26 Patency Checks... 26 Keypad Lock Operation ... 26 Auto keypad lock off ... 26 Auto keypad lock on ... 26 Pump Standby (Hold Mode) ... 27 Delayed Start ... 27 ALARMS ... 28 Air-in-Line ... 28 Audio... 28 Depleted Battery... 28 Door Not Fully Closed / Set Outside Channel ... 28 Door Open ... 28 Downstream Occlusion... 28 Downstream Pressure Limit – Reset Setting... 28 Infusion Complete... 28 Inactive Alarm ... 28 In Stop – Slide Clamp Closed... 28 Low Battery... 28 Very Low Battery ... 29 Battery Missing ... 29 Shut Door... 29 Slide Clamp Closed ... 29 System Error... 29 Upstream Occlusion ... 29

-2-

TIPS... 30 Prevent Nuisance Alarms ... 30 Managing Bolus before Occlusion (Downstream) Release... 30 WARNINGS AND CAUTIONS ... 31 CLEANING AND STORAGE ... 35 Storing ... 35 Battery Disposal ... 36 Battery Charging... 36 Battery Removal and Replacement... 36 SERVICING ... 37 To Return Pumps to SIGMA... 37 Required Maintenance and Frequency ... 37 ACCESSORIES ... 38 BATTERY COMPATIBILITY... 40 SIGMA IV SETS ... 41 COMPATIBLE IV SETS ... 42 Compatible Hospira IV Sets – WARNINGS ... 43 Compatible Baxter IV Sets – WARNINGS ... 45 APPENDIX A - SPECIFICATIONS ... 49 Master Drug Library (MDL) ... 49 Drug Library Transfer ... 49 Infusion Modes ... 49 Standard Gravity IV Sets ... 49 Size and Weight ... 49 Battery ... 49 Pump Characteristics and Flow Rate Accuracy ... 50 Wireless Network Interface... 50 Transmit power: 12 dBm typicalWireless Security ... 50 Environmental Limits ... 50 Display ... 50 Alarms and Alerts ... 50 Timekeeping ... 51 Logging Memory... 51 AC Power... 51 External Interfaces... 51 Standards ... 51 FLOW RATE ACCURACY... 53 1, 2 Effect of Fluid Container Height ... 53 1 Effect of Back Pressure ... 53 Flow Profile ... 53 BOLUS ACCURACY ... 59 DOWNSTREAM OCCLUSION ... 59 Time to Occlusion ... 59 Bolus Volume... 59 ELECTROMAGNETIC COMPATIBILITY ... 60 Emissions... 60 Immunity – ESD, transient/burst, voltage disparity, magnetic ... 61 Immunity – Conducted and Radiated... 62 Immunity – Separation Distances ... 63 Appendix B - Low / Very Low Battery Tutorial ... 65 Appendix C... 68

-3-

Appendix C - Power Icons ... 69 Appendix C - Wireless icons ... 70 Appendix C - General Icons... 72

-4-

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 before depending on the battery as a source of pump power.

-5-

KEY OPERATING TIPS 1. FOLLOW ALL PROMPTS. 2. LOAD SETS PROPERLY. To open the pump door, insert 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. Pus 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 drop hooks to drop primary containers below secondary containers. With secondary rates above 300 mL/hr, look for and clamp off primary line siphoning.

-6-

BACKGROUND INFORMATION Intended Device Use The Spectrum, Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products, antibiotics, nutritional fluids and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The Spectrum is intended to be used in conjunction with legally marked intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician’s directive.

-7-

System Components SIGMA Spectrum Pump:

Standard gravity IV sets:

with slide clamp

Fig 1

1

(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.

2

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

3

SIGMA Spectrum Infusion Pump (Fig 1)

4

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

-8-

SYMBOLS

!

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 receptacle. Recyclable, dispose of properly

+

-

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

-9-

ILLUSTRATIONS Front View – Door Open

- 10 -

Front View – Pump Running with Standard Battery

- 11 -

Front View – Pump Running with Wireless Battery Module

- 12 -

Back View- With Standard Battery

- 13 -

Back View- With 802.11b Wireless Battery Module (P/N 35083)

- 14 -

Back View- With 802.11b/g Wireless Battery Module (P/N 35162)

- 15 -

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.

-

ARROWS advance cursors and select alternate choices.

-

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

-

OK confirms entries and advances cursors.

-

SETUP starts programming.

-

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

-

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.

-

CLEAR erases the highlighted entry.

-

CLEAR PROGRAM allows selective clearing of primary mode, secondary mode or both.

-

PROGRAM SECONDARY allows access to the drug set up screen for a secondary infusion.

-

REVIEW PROGRAM displays set up screen when pump is stopped.

-

REVIEW PRIMARY/REVIEW SECONDARY allows viewing/editing of values in setup screen.

-

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

-

HOLD places the pump in standby mode.

-

ON/OFF turns the pump on or off.

-

RUN/STOP starts and stops the infusion.

-

OPTIONS allow the user to select additional pump features.

-

BACK allows the user to go back.

-

RESET resets multi-step and cyclic TPN programs to the start.

-

Multi-Step allows access to the Multi-Step Programming Mode.

-

CLR STEP clears one step of Manual Programming Mode.

-

TITRATE allows flow rate changes without stopping the pump.

-

BOLUS allows Bolus Setup without stopping the pump.

- 16 -

-

TAPER DOWN – allows a cyclic TPN program to taper down automatically.

-

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

Pre-Pump Programming -

MOUNT THE PUMP to an IV pole.

-

Plug the pump into a wall outlet if available.

-

-

-

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). 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. The Adaptor (power supply) side of the A.C. Power Adaptor is equipped with a Protector (P/N 45742). The Protector is a plastic enclosure which snaps onto the Adaptor. The purpose of the Protector is to protect the Adaptor from damage during use in hospital environment. The A.C. Power Adaptor with the Protector can be used on wall outlet and Pole Mount power strip receptacles. The Protector comes installed with the pump. The Protector cannot be removed from the Adaptor once it is installed. The Protector can be ordered separately as an accessory for installing on old A.C. Power Adaptor. A separate instruction bulletin on how to install the Protector will be send along with the Protector. The Protector is compatible with the cleaners mentioned in this Operators manual. Refer to the Cleaning & Storage section of this Operators manual for the methods of cleaning and compatible cleaners that can be used on the A.C. power Adaptor with Protector.

- 17 -

NOTE: IMPROPER REMOVAL MAY DAMAGE THE POWER ADAPTOR. Remove the Power Adaptor by grasping the handle of the Protector and pulling it back from the receptacle in a straight direction as shown in figure. Do not pull the Adaptor at an angle to avoid bending of the prongs. Do not pull the cord to unplug the Adaptor from the receptacle. Improper twisting or pulling of the connector or cord 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. -

-

-

-

-

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. OPEN THE SLIDE AND ROLLER CLAMP. TO UNLOAD SETS, close roller clamp, push the slide clamp in the keyhole until the door opens and pull tubing out from the bottom of the pump towards the top. 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 roller clamp fully closed, (except when following standard gravity set priming procedures).

Drug Error Prevention Programming -

Turn the pump ON.

-

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

-

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

-

-

Select the correct drug concentration (if more than one is offered). Press 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 press OK .

• •

- 18 -

•

Enter all required data. Press 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. -

Press RUN to begin the infusion. Confirm that all infusion parameters are as intended. • Confirmation that drops are flowing is required for SW versions 6.01 and later.

- 19 -

SW V5.02.03 and earlier versions

SW V 6.01 and later Dose Rate Limits

-

SOFT DOSE RATE LIMITS may be exceeded by pressing 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. N/A

-

-

-

-

SOFT DOSE RATE LIMITS may be exceeded by pressing OK followed by pressing the “YES” softkey to accept or the “NO” softkey to decline the dose rate displayed in the dialog box. HARD DOSE LIMITS can not be exceeded. Reset rates within HARD limits. RATE ADVISORY – dose or mL/hr rate entered is increased or decreased by a % (set in Master Drug Library) above or below the current rate. Press “YES” to accept or “NO” to decline the change displayed in the dialog box. In BASIC mode the default rate advisory is set at 101% and cannot be changed. The rate advisory will be 500% if the selected care area name contains “Anesthesia” or “OR”

Basic Programming -

Turn the pump ON. Press BASIC. If the prior setup needs to be erased, press CLEAR ALL. When the BASIC screen is displayed • •

•

-

Select primary or secondary bag. Press OK. Select mL/hr or use ARROW soft keys to scroll through dose rates. Press OK.

Enter the flow rate value. Press OK.

Enter the VTBI (Volume To Be Infused) in mL. Press OK. • Confirm the computed infusion time. • Confirm the Volume Given mL value (or press CLEAR to erase it). • Note: VTBI counts down to zero, while VOLUME GIVEN counts from zero up. Press RUN to begin the infusion. • Confirm all infusion parameters are as intended. •

-

-

-

Review/Reprogramming a Primary Infusion

- 20 -

-

Turn the pump ON. If the prior setup needs to be erased, press CLEAR ALL. Select care area, press OK Type BA to select Basic, press OK • Select primary or secondary bag using arrow key. Press OK. • Select mL/hr or use ARROW soft keys to scroll through dose rates. Press OK. • If a dose rate is chosen, enter drug concentration and diluent (mL) values • Enter the dose or flow rate value. Press OK. • Enter the VTBI (Volume To Be Infused) in mL. Press OK. • Confirm the computed infusion time. • Confirm the Volume Given mL value (or press CLEAR to erase it). • Note: VTBI counts down to zero, while VOLUME GIVEN counts from zero up. Press RUN to begin the infusion. Check flow displays for rates less than 25 mL/hr Press “YES” if drops are flowing, all clamps are open, no kinks in tubing. Press “NO” if no drops flow. Open all clamps and unkink tubing. Confirm all infusion parameters are as intended.

Review/Reprogramming a Primary Infusion