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TABLE OF CONTENTS 1. Purpose and scope……………………………………………………………………………………………………………………3 2. Definitions……………………………………………………………………………………………………………………………….. 3 3. Authority and responsibility……………………………………………………………………………………………………. 3 4. Reference & tools……………………………………………………………………………………………………………………. 3 5. Method…………………………………………………………………………………………………………………………………….. 3 Special notes……………………………………………………………………………………………………………………. 4 5.1 General troubleshooting guidelines………………………………………………………………………….. 4 5.2 General cosmetic damage………………………………………………………………………………………….4 5.3 Replacing the skin and veins……………………………………………………………………………………. 5 5.4 Manikin sounds verification………………………………………………………………………………………. 6 5.4.1 Sound verification setup……………………………………………………………………….. 6 5.4.2 Lung sounds…………………………………………………………………………………………… 7 5.4.3 Navigation buttons …………………………………………………………………………………7 5.4.4 Heart sounds………………………………………………………………………………………….. 8 5.4.5 Bowel sounds…………………………………………………………………………………………. 9 5.4.6 Vocal sounds…………………………………………………………………………………………… 10 5.5 Pulse sensors and tongue test…………………………………………………………………………………..11 5.5.1 Head assembly neck sensors………………………………………………………………… 11 5.5.2 Manual inflation of tongue……………………………………………………………………… 11 5.5.3 Left arm sensors……………………………………………………………………………………. 11 5.6 Blood pressure & pulses……………………………………………………………………………………………. 12 5.6.1 Cuff calibration………………………………………………………………………………………. 12 5.6.2 Left arm speaker……………………………………………………………………………………. 13 5.7 Pneumothorax (bladder) test……………………………………………………………………………………. 13 5.7.1 Tension pneumo inflation………………………………………………………………………. 13 5.7.2 Replacing (chest) bladder……………………………………………………………………… 14 5.7.3 Replacing (torso) bladder………………………………………………………………………. 14 5.8 Defibrillation – ECG test……………………………………………………………………………………………. 15 5.8.1 Defib. Setup…………………………………………………………………………………………….15 5.8.2 ECG monitoring……………………………………………………………………………………….15 5.8.3 Energy delivery………………………………………………………………………………………. 16 5.9 Computer system communications test ………………………………………………………………….. 17 5.9.1 Initial Setup……………………………………………………………………………………………. 17 5.9.2 Transferring file……………………………………………………………………………………… 17 5.9.3 Remote control………………………………………………………………………………………. 18 5.9.4 Frame 0 (no vital signs)………………………………………………………………………… 18 5.9.5 Frame 1 (revived patient)……………………………………………………………………… 19 5.10 Interface board and load box board operation……………………………………………………. 19 5.10.1 Access to boards………………………………………………………………………………….. 19 5.10.2 Interface PCB………………………………………………………………………………………..19 5.10.3 Interface PCB schematic……………………………………………………………………… 21 5.10.4 Load box board and schematic……………………………………………………………. 22 5.10.5 Manikin wire harness distribution Exhibit 1………………………………………… 23 5.10.6-7 Head Upgrade & MegaCode Kelly Basic/Advanced Exhibit 2-A……….24 5.10.8 BOM Head Assy., MegaCode Kelly Basic/Advanced Exhibit 2-B ...….. 25 5.10.9 Torso Assy., MegaCode Kelly Advanced Exhibit 3-A …….…………………… 26 5.10.10 BOM Torso Assy., MegaCode Kelly Advanced Exhibit 3-B ……………… 27 5.10.11 Chest Plate Assy., MCK Advanced 3-C……………………………………………… 28 5.10.12 Chest Plate Assy. MCK Advanced 3-D….…………………………………………… 29 5.10.13 Chest Plate assy. MCK Advanced 3-E………………………………………………. 30 5.10.14 Torso Assy., MegaCode Kelly Basic Exhibit 4-A …………………………….. 31 5.10.15 BOM Torso Assy., MegaCode Kelly Basic Exhibit 4-B …………………….. 32 5.10.16 Chest Plate Assy., MCK Basic 4-C…………………………………………………….. 33 5.10.17 Chest Plate Assy. MCK Basic 4-D….…………………………………………….…… 34 5.10.18 Chest Plate assy. MCK Basic 4-E………………………………………………………. 35 Page 2 of 35

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PURPOSE AND SCOPE The purpose of this work instruction is to help guide Authorized Laerdal Medical Service Centers on troubleshooting, repairing and shipping the MegaCode Kelly Basic & Advanced manikins back to the customer. This work instruction will also cover how to install the new manikin head with new airway for LMA and Combitube practice to the old MCK manikins. The information in this work instruction is limited to general troubleshooting and replacement of major vinyl manikin parts, wiring assemblies and replacement of modular circuit assemblies.

2.

DEFINITIONS PCB – Printed Circuit Board PPF – Product Portfolio File MCK – MegaCode Kelly LMA – Laryngeal Mask Airway

3.

AUTHORITY AND RESPONSIBILITY Service Personnel has the Authority to maintain this work instruction to ensure that it is accurate and relevant. It is the responsibility of Service Personnel to ensure that this work instruction is acted upon and followed. Service Personnel have the authority and responsibility to report any product non-compliances in regards to operation and safety to the CAPA team, per SOP-10020002, Corrective Action and Preventative Action

4.

REFERENCES & TOOLS 200-12050 VitalSim Control Unit Directions for Use SOP-1002-0002 Corrective Action and Preventative Action SOP-0502-0001 LNY Customer Contact and Service Provision Procedure 720-011-00 Electrostatic Discharge (ESD) Work Instruction All other specifications found on DocuShare or (PPF) for the product. TOOLS NEEDED Hex wrench 7/16”, Phillips and flat head screw drivers and pliers. Rubbing Alcohol or equivalent – Containing 70% Ethyl Alcohol by volume Paper towel or paper cloth PC or Laptop with VitalSim software Ver. 2.2 or greater Stethoscope (optional) Sphygmomanometer (Cuff) Knife (when replacing the IV Arm skin and veins) Fluke 87 or equivalent Ohm meter. Adhesive - Loctite 498 HP CodeMaster 100 Defibrillator/Monitor with 3-lead ECG monitor cable or equivalent.

5.

METHOD MegaCode Kelly (MCK) Basic or Advanced are full-body, lifelike manikins designed to realistically simulate advanced, difficult and obstructed airway scenarios, IV therapy, cardiac defibrillation, measurement of non-invasive blood pressure, and the auscultation and recognition of heart, breath and abdominal sounds. Page 3 of 35

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SPECIAL NOTES: #1

If and when a MCK manikin is returned for service or routine maintenance, the complete set of verifications must be performed to ensure proper operation.

#2

Caution must be taken when testing the manikin with the Defibrillator.

#3

Ensure that all ESD protection has been taken prior to troubleshooting the internal electronics of the manikin.

#4

All tests must be completed with a VitalSim unit and Remote control turned ON.

#5

The Basic MCK manikin does not have sounds and it has the standard arm in place of the Blood Pressure Arm.

#6

Customers with old MCK advanced manikins may request a Head Upgrade for LMA and Combitube compatibility. If and when we receive a request for an upgrade follow Exhibits 2-A thru 4-B

5.1

GENERAL TROUBLESHOOTING GUIDELINES Upon receiving the MegaCode Kelly manikin for service/repair, make sure that the customer complaint is confirmed first by trying to duplicate the reported failure. Perform the following steps to verify the reported failure. a) Look Listen and Feel for broken parts or subassemblies. b) Determine if it is cosmetic damage (i.e. torn skin or other). c) Determine if it is a communication problem (check the communication cables from the manikin to the PC or the VitalSim unit). d) Determine if it is an Electronic problem (defective printed circuit board, wire harness or sensor).

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MegaCode Kelly Manikin without Legs 5.2

GENERAL COSMETIC DAMAGE Once you have determined that the product was returned due to a cosmetic damage. Proceed to replace the torn or broken part, refer to the replacement parts list found on the MCK DFU for the correct replacement part.

5.3

REPLACING THE SKIN AND VEINS If replacing both skin and veins, cut off skin and discard. The thumb will detach with the skin (new skin has a thumb). Replacing skin: Cut off skin. This can be done with a sharp knife or scalpel. (Figure A) Discard skin. Replacing veins: (Keeping skin) Lubricate inside of skin with liquid detergent; let it flow down into the finger area. Begin at top of arm and slowly pull skin down and off of arm. Do not roll, as that will cause skin to bind. Thumb will detach with skin. Remove tubing from track in mandrel. Glue may need to be scraped away to allow removal. Rinse and dry vein grooves well and swab with alcohol. Be sure to remove any excess glue. Place new veins along grooves, (Figure B) spot gluing as needed with Loctite 498. Generously lather arm mandrel with liquid soap.

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Fig.A Fig.B

Slide hand into new skin. (Photo 1)

Photo 1

Work skin over fingers, as with a glove. (Photo 2)

Photo 2

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Work arm skin up, over mandrel. (Photos 3 & 4.)

Photo 3 5.4

Photo 4

MANIKIN SOUNDS VERIFICATION (Auscultation)

NOTE: There are no sounds on the MCK Basic manikin. 5.4.1 To verify the manikin sounds (Heart, Breath, Bowel and Vocal). Connect the manikin to the VitalSim Unit, via the cable on the back of the manikin and the 10 foot manikin connecting cable and the remote control. (figure 1 ). Figure 1

5.4.2 Lungs Sounds Turn on the power to the VitalSim control unit and remote control. Immediately thereafter you should hear the breathing sound coming from the speakers on chest and sides on the manikin (figure 3 & 4). If no sound is heard, investigate, check the wires and connectors going to and from the speakers or check the resistance of the speaker (approx. 8 ohms). Figure 3

Side speaker (X2)

Figure 4

Lung speakers (X4)

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PRO-PR02-0005 Rev C 5.4.3 Using left / right navigation buttons on the remote control, (figure 5). Tab over to the right of the screen and select the Lungs, (figure 6). Choose at least 3 of the listed sounds from the lungs sound selection (use Stethoscope if available). (#3 Fine Crackles, #6 Rhonchi and #8 Wheezes) If no sound is heard, investigate by checking the wires and connectors going to chest speaker (Qty. 4) or the side of the manikin (Qty.2), 6 speakers in total. Figure 5

Figure 6

Figure 7

5.4.4 Heart Sounds Using up / down navigation buttons on the remote control, (figure 5) tab down and select Heart. Choose at least 3 of the listed sounds of the heart selection, using Stethoscope if available (figure 8). #3 Austin Flint Murmur, #6 Systolic Murmur and #8 OS@70ms /open snaps MS. If no sound is heard, investigate, check the wires and connector going to and from the heart speaker (Qty.1) of the manikin, (figure 10) Figure 8

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Figure 10

Heart speaker (Qty. 1)

Heart speaker from chest

Lung speaker from chest X4

5.4.5 Bowel Sounds Using up / down navigation buttons on the remote control, tab down and select Bowel. Choose at least 3 of the listed sounds of the bowels selection, using Stethoscope if available. (figure 11). #2 Hyperactive and #4 Hypoactive. If no sound is heard, investigate check the wires and connector going to and from the bowel speaker (Qty.1) of the manikin, (figure 12). Figure 11

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Figure 12

Listen to bowel sounds with Stethoscope on upper abdominal as shown here.

5.4.6 Vocal Sounds Using up / down navigation buttons on the remote control, tab down and select Vocal, (figure 13). Choose at least 3 of the listed sounds of the Vocal selection, (figure 14). #1 Cough, #4 SOB Breathing (continuous) and #7. If no sound is heard, investigate, check the wires and connector going to and from the Head speaker. Figure 13

Figure 14

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Old Version of Head & Speaker

Figure 15

5.5 Pulse Sensors and Tongue Test 5.5.1 Head Assembly Neck Sensors The head has a sealed oral airway that is anatomically correct with two electronic pulse sensors mounted in the side of neck, (figure 16). Verify that the pulse sensors work properly by placing your index and third fingers on the neck sensors. You should feel a pulsating beat. If there is no pulse on the neck sensors, investigate, check the wire harness going to the head, if the failure continues disassemble the head and test the sensors directly. Figure 16

Neck Sensor (X2) 5.5.2 Manual Inflation of Tongue Locate inflation bulb labeled “Tongue”. Pump bulb several times to inflate tongue. When tongue is inflated to desired size, tighten air release knob. To deflate tongue, loosen air release knob. If it fails, look for holes on the tongue assembly.

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5.5.3 Left Arm Sensors Verify that the left arm sensors (X2) work properly by placing your index and third fingers on the arm as shown, (figure 17). You should feel a pulsating beat. If there is no pulse on the arm sensors, investigate, check the wire harness going to the arm, if the failure continues disassemble the arm and test the sensors directly. Figure 17

Left Arm sensor

5.6

Blood Pressure & Pulses on MCK Advanced only The Blood Pressure (BP) consists of 1/8” ID tubing that enters in the lower right underside of the torso. It originates at the VitalSim Trainer. The tubing passes to the right and then travels up to exit thru a hole near the left arm. There is a quick disconnect fitting that mates with a fitting mounted on the Blood Pressure Arm Cuff. As the BP Cuff is pumped, the pressure is sensed by the VitalSim trainer. The VitalSim Trainer will react based on the BP presets entered by the VitalSim operator. See figure 18. VitalSim Blood Pressure Cuff Assembly

Figure 18 Page 12 of 35

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5.6.1 Cuff Calibration To Calibrate the VitalSim Unit and the Cuff, strap the cuff to the left arm and tighten the air release knob on the inflating bulb. Select the menu button from the VitalSim remote control unit and inflate the cuff up to 100 mmHg and press the “Calibrate” button on the remote control unit. Verify that the remote unit confirms that the unit is calibrated to 100 mmHg. 5.6.2 Left Arm Speaker (Blood Pressure Test) Using the up / down navigation buttons on the remote control, tab down and select BP, (figure 19). Strap the cuff on the left Arm and clear tubing to the side of manikin with the Stethoscope as shown in (figure 20). Inflate the bulb and tighten air release knob so that as you pump the bulb no air escapes. Pump the bulb until the reading on the Sphygmomanometer reaches 140 mmHg. While listening with the Stethoscope, verify that the blood pressure (Korotkoff sound) is within the selected range (i.e. 120 Systolic/80 Diastolic). You can change the range selection by changing the Systolic and Diastolic settings. If there is no sound on the arm speaker, investigate, check the wire harness going to the arm, if the failure continues, disassemble the arm and test the speaker directly. Figure 19

Change the Systolic and Diastolic

Figure 20 BP test setup.

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Pneumothorax Test (Bladder) 5.7.1

Tension Pneumo Inflation Locate inflation bulb labeled “Pneumo” which exits on the left side of torso. Tighten air release knob so that as you pump the bulb, no air escapes. Pump bulb several times and verify that all four (4) bladders inflate, two (2) on the upper chest and two (2) on the side of torso. If the bladders do not inflate, check for air leakage on the tubing from and to the bladders, replace if needed per step 5.7.2 or 5.7.3.

5.7.2

Replacing Bladders Mid-Clavicular (Chest) Remove Chest Skin from torso. Lift chest plate exposing underside. Remove screws that secure bladder retainer, (figure 21). Remove foam pads, disconnect bladder hose from inline hose connector. Make sure hose does not fall through hole and into torso. Remove bladder from site cavity, (figure 22) and slip hose out of cable tie. Trim bladder tubing to match original tubing length to fit this manikin style. Insert new pneumo bladder into site cavity and reposition hose under cable tie. Reconnect hose to inline hose connector. Replace foam pads over pneumo bladders. Secure bladder retainer to chest plate with screws removed previously. Return chest plate to proper position on torso. Replace chest skin over torso, being sure to secure skin at shoulders. Figure 21

5.7.3

Figure 22

Replacing Bladders Mid-Axillary (Torso sides) Remove chest skin from torso and remove pneumo pad from side of torso, (Figure 23). Disconnect bladder hose from inline hose connector, make sure hose does not fall through hole and into torso. Remove bladder from pneumo pad and discard. Trim bladder tubing to match original tubing length to fit this manikin style. Connect new bladder hose to inline hose connector. Insert new pneumo bladder into pneumo pad. Replace chest skin over torso, being sure to secure skin at shoulders. Figure 23

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DEFIBRILLATION - ECG TEST 5.8.1

Connect the Defibrillator cables and ECG Monitoring cables to the manikin, (figure 24) and select Monitor on the Defib. Select Lead III, (figure 25) by pressing on the lead select button. 3-Lead monitor cable Defib. Cable a) LA = Left Arm (Black) a) Sternum (White) b) RA = Right Arm (White) b) Apex (Red) c) LL = Left Leg (Red) Figure 24

5.8.2

Figure 25

ECG Monitoring Using the up / down navigation buttons on the remote control, tab down and select A: Sinus, Choose at least 3 of the listed Rhythms and verify that the monitor screen changes as well. Select #1 Sinus Rhythm (figure 26) and change the Heart rate (HR) by increasing or decreasing the values using the + or – buttons. Verify that the rhythm on the monitor screen changes as well. Select #6 Sinus w/PJCs and #15 V.fib Medium. Figure 26

Increase or decrease the Heart rate by using the HR buttons below.

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5.8.3 Energy Delivery (CAUTION: keep hands off the manikin) Once you have selected one of the above rhythms, select 360J energy on the Defib. And press charge on the Defib. (figure 27). Proceed to deliver the energy to the manikin and verify that both the Defib. Unit and the VitalSim remote control unit register the action taken, (figure 28). If the manikin fails to respond to any of the above test check all the cable connections and the electrode snap contacts. Verify the wire harness and the Defib. ECG connector going to the Load box PCB. (see manikin wire harness distribution Exhibit 1) Figure 27

1) Select energy 360J 2) Press the charge button 3) Press the shock buttons to deliver energy.

Figure 28

Event notification “Defibrillation occurred”

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COMPUTER SYSTEM COMMUNICATION TEST Note: this section is only one of many examples of how to test for system communication.

5.9.1 To test if the computer is communicating with the manikin via a saved scenario, first make sure that the USB from the VitalSim unit is connected to the USB port on the back of the computer system. If you are creating a new scenario, select the “Scenario Builder” folder from the desktop, (figure 29). Select File from the tools bar and the “Load Scenario” (figure 30). Figure 29

Figure 30

5.9.2.1 To load a scenario i.e. “Ma.scn” (figure 31). Immediately thereafter, you will see the patient type scenario (Frame 0 and Frame 1) (figure 32) Figure 31

Figure 32 Frame 0

Frame 1

5.9.2.2 To Transfer a scenario to the control unit, select from the desktop “Log and Scenario” icon the press the “ADD” then select the “MA.SCN” file from the listed scenarios, press “OPEN” and then “Exit and Update”.

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5.9.3 Press the Scan button (figure 33) on the remote control and it will detect the Ma.scn file being transferred from the computer to the VitalSim unit, (figure 34). Press the OK button on the remote control and it will transfer the file to the manikin, you will get the following message “Please wait Loading Scenario Events”. (figure 35) Figure 33

Figure 34

Scan button

Figure 35

5.9.4 Frame 0, (figure 36) depicts a Male patient with no vital sings, requiring 3 shocks to revive the patient. After the Ma.scn file is transferred to the VitalSim unit, the patient vital signs will appear on the remote control, (figure 37). The breathing sounds will stop on the manikin and the ECG rhythm will be unrecognizable. Figure 36

Figure 37

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5.9.5 After the 3 shocks are delivered and the patient is revived the vital signs shown on Frame1, (figure 38 should register the same on the remote control, (figure 39). If it fails this test verify that all of the cables are properly attached to the manikin, VitalSim unit and the computer. If problem continues verify, the functionality of the individual modular assemblies. Figure 38

5.10

Figure 39

INTERFACE BOARD AND LOAD BOX BOARD OPERATION 5.10.1 To access the Interface PCB and Load Box PCB remove the screws covering the back plate on the torso (figure 40). The Interface Printed Circuit Board (figure 41) connects to the VitalSim Trainer and manikin via the DB-37 connector cables. Figure 40

5.10.2 The Interface PCB will distribute the operating voltages and signals to the various wiring harnesses that interconnect to it. The phone cable (cable interface) supplies all the signals to the load box PCB, (figure 43) that support the ECG signals and defibrillation detection. The Ribbon Cable supplies the voice, heart, lung, and bowel sounds. The Ribbon Cable also supplies access to the pulse sensor and activates the various pulses. Page 19 of 35

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Figure 41

Interface PCB Make sure that the correct setting on the DIP Switch, for the manikin you are working on is selected prior to replacing the Interface Board. The Voice sounds can be selected by opening or closing the DIP switches on S-1 (Figure 42). Manikin type Adult Male Adult Female Child Infant

DIP Switch (S-1) Settings S1 Closed, S2, S3, S4 Open S2 Closed, S1, S3, S4 Open S3 Closed, S1, S2, S4 Open S4 Closed, S1, S2, S3 Open

Voltage 1.41 +/- 0.1V 1.70 +/- 0.1V 2.03 +/- 0.1V 2.50 +/- 0.1V

Figure 42

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