Colleague Infusion Pump Family Repair and Test Procedure Training Guide

Colleague Functional Testing Training

• This training covers the activity described in Service Bulletin 17-32-1-050 • 1.0 Purpose: – To provide a repair, inspection and test procedure for the Colleague, Colleague 3, Color Colleague CX, Color Colleague 3 CX, Color Colleague Guardian Enhanced CXE and Color Colleague Guardian Enhanced 3 CXE Volumetric Infusion Pump Family.

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General Information, Materials Required, Warnings & Cautions • 3.0 GENERAL INFORMATION • Para 3.1 Required Test Equipment and Supplies • Para 3.2 Warnings and Cautions

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INITIAL PUMP PREPARATION AND TRIAGE & DECONTAMINATION 4.0 INITIAL PUMP PREPARATION AND TRIAGE This section provides steps for assessing device condition. If the pump was stored in temperatures outside its operating range, 59 - 100°F (15 – 38°C), allow the pump to stabilize at room temperature for three to four hours before proceeding. . 4.1 Decontamination Para 4.1.1 Prior to beginning work on the pump, verify the device has been decontaminated per applicable procedures as designated by the healthcare facility or as specified in the product operator’s manual. Para 4.1.2 Pumps with suspected deposits of potentially infectious material are to be decontaminated. Para 4.1.3 If the device requires decontamination, this can be accomplished by cleaning the exterior using a soft cloth dampened, but not soaked, with a 10% bleach and water solution or other approved cleaner. Refer to the operator's manual and/or global service manual for the approved cleaning agents and detailed 4 cleaning instructions.

Decontamination • IMPORTANT: DO NOT SPRAY cleaners onto the pump or into the pump head. • Para 4.1.4 If internal contamination is suspected or has been found to be present upon subsequent opening of the pump, bag the pump as biohazardous, discontinue processing and set the device off to side. • Para 4.1.5 Decontaminate any affected surrounding workspace and advise the customer that the pump cannot be upgraded. • Para 4.1.6 Record whether decontamination has been performed by circling the appropriate response on the device data sheet. 5

4.2

Hardware Configuration Check

• 4.2.1 Review the device configuration label affixed to the bottom panel of the pump Verify the pump meets the following hardware criteria: • · For Monochrome Pumps the label is Marked "10" • · For Color Pumps the label is Marked configuration "5" • If the pump does not meet the minimum configuration requirements above DO NOT process the pump per this procedure. Use 07-27-49-378 for performance of mandatory product upgrades in conjunction with required repair activity.

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Visual Inspection • 4.3 Physical Inspection • Para 4.3.1 Record any written or verbal information provided by the customer regarding device performance issues in the "Comments" section of the data sheet. • Critical Note: Do not process any device if the customer information indicates that the pump may have been involved with a Death or Serious Injury. Further definition of Death or Serious Injury is contained in FDA 21 CFR § 803.3(bb)(1) and European Union Medical Devices Directive (93/42/EEC). Immediately contact Baxter Corporate Product Surveillance at 1-800-437-5176 or the local / regional Baxter Complaint office. 7

Visual Inspection •

Para 4.3.2 Visual Inspection Inspect the exterior of the pump and look for any loose or missing parts and damage that requires repair. This inspection includes verifying: –

Housing components are intact. Minor cracks in the housings are permissible as long as they do not compromise the structural integrity or allow ingress of solutions.

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All keypads and display windows are intact and not damaged in a way that affects function or legibility. Verify that the RTV seal around these components is intact.

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Mounting (pole) clamp knob moves freely through it’s range of motion and pads are present. (Note this is a removable item and, therefore, some pumps may not have this component installed at time of inspection)

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The Panel Lockout push button knob is present.

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The Power cord and Cord Wrap is present.

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All Pump Feet are present and secure.

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All Labels are present and legible.

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Visual Inspection • •

Para 4.3.3 Record that inspection was completed. Note issues from visual inspection in the comments section on the data sheet. Para 4.3.4 Non-Warranty Repairs such as Accidental damage or improper handling and care; refer to local guidelines for estimate handling and customer liaison.

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Power Up Self-Test/Display/Icon Tests • • •

4.4 Power Up Self-Test/Display/Icon Tests Para 4.4.1 For regions using power cords 5009415146, verify the cord has "65 X 36" marked or stamped on the outer jacket. Replace the cord if it fails. Para 4.4.2 Inspect the power cord for major physical damage to assure it is safe to connect to AC power. The cord shall not have damage such as cuts through the outer jacket, broken strain relief or bent lugs on the plug. Minor scuffs and scratches are acceptable. If the power cord has visible damage, replace it.

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Note: If an old style cord retainer is removed during service, replace it with the new slotted type (p/n F06910001) and the shoulder screw (p/n 4009330115). Para 4.4.3 With the unit connected to AC power, rock cord up and down at pump housing while observing the AC icon on front panel. If the icon goes on and off with the motion of the line cord (indicating intermittent connection), the power cord requires replacement. 10 Para 4.4.4

Power Up Self-Test/Display/Icon Tests • Para 4.4.5 Perform a power-on self test and verify that the following occurs: – The Main Display is completely lit by the backlight. – The Monitor, Computer Control and the Battery icons turn on momentarily then the AC icon remains lit. – All eight digits of the pump module display fully illuminate momentarily and the three LED’s light up momentarily. – Verify that three distinct audible tones are heard (backup beeper sounds two times then the alarm tone sounds once). Record the results on the data sheet. Note: Color displays have a blue background with some red, yellow, and green text and graphics. The contrast setting can affect the color hue. 11

Power Up Self-Test/Display/Icon Tests

• Para 4.4.6 If an alarm occurs upon power-up, attempt to clear or reset the alarm condition. Record the results on the data sheet in the “Alarms / Fail Codes” section. Any failures that require repairs beyond the available capabilities at the location, will necessitate return of the device to an appropriate repair facility for processing. • Para 4.4.7 Adjust the contrast control (located on the rear left side of the handle) and verify that the display text changes in brightness. Slippage of the contrast control knob is acceptable at the adjustment end of travel as long as a change occurs when the control knob is reversed. Record results on the data sheet. • Para 4.4.8 Remove the pump from AC power. Verify that the Battery Icon turns on and the Plug Icon turns off. Record results on the data sheet. • Para 4.4.9 Plug in the pump. Verify that the Plug Icon turns on and the Battery 12 Icon turns off. Record results on the data sheet.

4.5 Fan Check (Colleague Triple Channel Only) • Para 4.5.1 Verify that the fan is functioning, by listening for sound from the fan when the pump is plugged into AC. Record results on the data sheet.

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4.6 Event History • •

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Para 4.6.1 From the pump’s main display, press the Options soft key to access the Options Menu screen. Para 4.6.2 Press the up arrow key once (conserves event accumulation) to highlight Configuration / Service and press the Select soft key to access the Configuration/Service Pass code Entry screen. Para 4.6.3 Enter 8151 then press the Enter Pass Code soft key to access the Configuration/Service Menu screen. Para 4.6.4 Press the down arrow key to highlight Event History and press the Select soft key. Press the Select Report soft key and select Condensed. Press Show Report. Para 4.6.5 View the entire Condensed Event History and check for failures (“Failure:... ”). Record all failures on the data sheet that the history has been checked. List all 14 fail codes in the “Alarms/Fail Codes” section of the data sheet.

4.7 Two Minute Run Test • Para 4.7.1 Load a fully primed set and program a rate of 1200 mL/hr and a volume of 40 mL. On triple channel pumps, set up all three channels. • Para 4.7.2 Make sure the distal end of the set is either looped back to the bag or allowed to drain into a container. Press the Start key and allow the pump to deliver 40 mL. • Para 4.7.3 Allow the pump to run for a minimum of 2 minutes. • Para 4.7.4 Indicate and record if the pump ran without failure or alarm on the data sheet. Record specific alarms and fail codes in the space provided. 15

4.8

Battery Check

Para 4.8.1 Access the Service Features screen and select the Battery and pump History Screen according to the instructions in the Colleague Global Service Manual. Record the following information on the Data Sheet. – “Battery Installed” date and time (Replace if =1990) – “# of Charge/Discharge Cycles” (Replace if >68) – “# of Discharges < Alrm Thrshld” (Replace if >1)

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PERFORM REPAIRS • 5.0 PERFORM REPAIRS • Record all alarms, failure codes and required repairs encountered during the upgrade process in the COMMENTS section of the data sheet.

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Archive Personality Configuration • •

5.1 Archive Personality Configuration Notes: 1. The Personality Storage Pump must contain the same software version that is to be installed in the device in order to restore the Personality Configurations. 2. Spanish software only: Review any custom label abbreviations to make sure the "degree" symbol is not used. If the "degree" symbol is used, advise the customer that Archiving cannot be performed until the symbol is reprogrammed. 3. If a pump to be upgraded is received with "Permanent Settings" only (no custom personalities), archiving is not necessary. Configuration Transfer testing will be performed later in section 6.

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Para 5.1.1 Power On the pump being upgraded. Enter the Configuration/Service menu and record the current UIM software versions on the data sheet. Para 5.1.2 Obtain a Personality Storage Pump containing the appropriate UIM software as indicated in the table below: 18

Archive Personality Configuration

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Note: If a pump requiring upgrade contains software for which transfer should not be attempted, skip archiving and move forward to the next step 5.2. Configuration Transfer will be performed later in section 6 with a Personality Storage Pump that has been pre-configured by the customer. 19

Archive Personality Configuration • Para 5.1.3 With both pumps Off, connect the Configuration Transfer Cable (2M8155) from the COMM. PORT of the pump being archived to the corresponding port on the Personality Storage Pump. • Para 5.1.4 While connected to AC, turn On the pump to be archived. Access the Configuration/Service menu, enter the passcode and select the Personality Configuration screen in order to begin archiving. • Para 5.1.5 Record the Power On Default Personality number on the data sheet. This will serve as the identifier for this pump's Personality Settings. • Para 5.1.6 Attach an identification tag or label onto the Personality Storage Pump, referencing the serial number of the pump being archived. • Para 5.1.7 Turn On the Personality Storage Pump. 20