TSM Draft

SimMan 3G

TM

Technical Service Manual

Page 1 of 127

TSM Draft

Table of Content
About this manual Other applicable documents 1.0 General product Overview 1.1 SimMan 3G Simulator and System 1.2 Technical Specifications 1.3 Regulatory Information 2.0 Tour of the Simulator 2.1 External Connections and Vascular Access 2.2 Overview for Blood and fluid Outputs 2.3 Overview Pulses 2.4 Internal System Overview 2.5 Speaker and Sound System Overview 3.0 Functional Description 3.1 General Overview, Functions & Electronics 3.2 Compression System 3.3 CO2 System 3.4 Bleeding & Fluid System 3.4.1 Bleeding System Pelvis 3.4.2 Fluid distribution Unit Pelvis 3.5 Lung Module 3.5.1.1 Compliance 3.5.1.2 Restriction 4.0 Functional Verification 4.1 Battery Operation 4.2 Battery change 4.3 Battery Heat warning 4.4 How to access the Test Utility Program 4.5 Test Utility Program 4.5.1 Head 4.5.2 Arm 4.5.3 Valve 4.5.4 Leg 4.5.5 Vital Signs 4.5.6 Sounds 4.5.7 Comp/Vent 4.5.8 Pulses 4.5.9 Versions 4.5.10 Power 4.5.11 Defib/Pacing 4.5.12 Test 4.5.13 Bootloader 4.5.14 Autotest 4.5.15 Debug 4.6 Manikin statistics 5.0 Interconnection System 5.1 Cable Connections between circuit boards 5.2 Base Board cable connections 5.3 Head Board cable connection 5.4 Valve Board cable connections 5.5 Xxx 5.6 Compressor Board cable connections 5.7 Drug registration Board cable connections 5.8 Tubing in Head, air distribution

Page 2 of 127

TSM Draft
6.0 Exploded views 6.1 Head Assembly 6.2 Skull Lower Assembly 6.3 Eye Assembly 6.4 Airway Assembly 6.5 Neck Assembly 6.6 Thorax Right Assembly 1 6.7 Thorax Right Assembly 2 6.8 Thorax Right Assembly, total 6.9 Thorax Left Assembly, total 6.10 Thorax Base plate Assembly, first step 6.11 Thorax Base plate Assembly, with cables 6.12 Thorax Base plate Assembly, w/ Base Board 6.13 Back Cover Assembly, w/speakers 6.14 Torso (back) Assembly 6.15 Torso (front) Assembly 6.16 Compression Spring Assembly 6.17 Compression Plate Assembly 6.18 Chest Assembly 6.19 Torso Assembly, total 6.20 Torso Assembly w/ Pelvis and Stomach, complete 6.21 Left Leg Assembly 6.22 Leg Right Assembly 6.23 Pressure Tank 6.24 Lower Right Leg Assembly 6.25 Compressor Assembly 6.26 Left Arm, BP Arm Assembly, complete 6.27 Left Arm w/pulse skins 6.28 Right Arm, IV Arm Assembly, complete 6.29 Flow meter Assembly 6.30 IV Arm w/antenna Networking and Communication System 7.1 Networking Overview Communication System 7.2 ATTACHMENT ATTACHMENT ATTACHMENT ATTACHMENT I II III IV SimMan 3G Simulator Final Service Test Check List Service Parts SimMan 3G Graphical User Interface - GUI SimMan 3G Troubleshooting Guide

7.0

Page 3 of 127

TSM Draft

About this manual

The information provided in this manual is limited to what is required for checking, maintaining and repairing of the SimMan 3G manikin. This service manual provides a general understanding of the design and function of the manikin and it associated peripherals as well as information on the mechanical assembly of the manikin. Please note that the Direction for Use manual provided with every new manikin should be consulted for detailed information on use of the product. To be able to read schematics and drawings in detail, this manual includes some pages in which need to be printed in A3 format.

Note

Other Applicable Documents

SimMan 3G Direction for use SimMan 3G Quick Setup Guide SimMan 3G Quick Reference Guide SimMan 3G Software User Help Files Laerdal E-learning Lifesaving Products, Laerdal Products Catalogue Service of the SimMan 3G simulator should only be performed by authorized service personnel. Service by others may invalidate the warranty of the product.

Note

Warnings (For a complete list of Cautions and Warnings, see Directions for Use) Defibrillation of the manikin must only be performed on the specified defibrillation connectors. Do not perform more than three defibrillation discharges (max 360J) in sequence. Take all standard precautions when handling defibrillators. Do not open the air compressor with compressed air in the tank; always drain the compressed air before service. The compressor has to be switched OFF when filling the reservoir with fluid or simulated blood.

Page 4 of 127

TSM Draft

1.

GENERAL PRODUCT OVERVIEW 1.1. SimMan 3G Simulator and System

The SimMan 3G system is based upon a modular system architecture in which a variety of software and hardware components communicate using standard internet & network technology. The SimMan 3G manikin itself is a complete self contained system, which doesnt require physical connections to any hardware.

Page 5 of 127

TSM Draft

1.2. Technical Specifications 1

Manikin Power: o External power: Input voltage: 24VDC, 6.25A o Internal batteries (two): 14.8V, 4.6Ah, Lithium Ion o Battery capacity Normal Patient**: 5C : 4h 20 min Room temperature: 4h 15 min 40 : 3h 10 min o Battery capacity Worst case Patient***: 5C: 3h 35 min 40C: 3h 10 min **Healthy patient: Auto Mode Healthy Patient 3G ***Worst case: Auto mode - Healthy patient 3G - Compliance:3 - Breathing: 60 - Convulsion: Tonic - Sounds: Cough (set on repeat) - Right arm pulse: Activated - Trismus activated - Swallowed tongue activated - Decreased cervical activated CAUTION: Only use external power adaptors and batteries approved for SimMan 3G by Laerdal Medical. Air/CO2 pressure: o Internal air tank: max 1.4 bar o External air connection: max 1.4 bar o External CO2: max 1.4 bar RF Communication Frequencies o WLAN frequency ranges: 2.4 GHz WLAN, typically channels 1-11 o Operation range: 100m (300ft) max NOTE WLAN transmissions can be disabled o RFID frequency range: 13,56 MHz o Operational range:< 0,2m NOTE RFID transmission cannot be disabled Weight and size (including batteries) o Manikin: 45kg (99 lbs) o Complete system with cases: 70kg (154 lbs) o Dimensions (manikin only): 1750mm x 750mm x 350mm Temperature Limits o Operating: +4C - + 40C (39F to 104F) o Storage*: -15C - + 50C (5F to 122F) *Requires that all fluid containers and systems have been flushed with a 30% alcohol / distilled water solution, and then drained completely. Environment manikin only: o Relative humidity: 15 90 % RH (non condensing) o Indoor and moderate outdoor use (light rain) NOTE Not tested with salt spray

Page 6 of 127

TSM Draft

1.3. Regulatory Information

1.3.1. Environmental Considerations
SimMan 3G falls within the scope of the EU Directive concerning ROHS. This Directive restricts use of certain hazardous substances within Europe. Laerdal Medical AS has gathered information from our suppliers of components concerning ROHS restricted substances and has used appropriated methods to ensure the accuracy of such information. SimMan 3G contains electrical and electronic components. Dispose of it at an appropriate recycling facility in accordance with local regulations. The batteries used in SimMan 3G contain chemicals. Recycle the batteries at an appropriate recycling facility in accordance with your local regulations. Both SimMan 3G and batteries are labeled with the symbol indicating separate collection. Applicable regulations: EU Directive, 2002/95/EC, ROHS EU Directive, 2002/96/EC, WEEE EU Directive, 2006/66/EC, Batteries

1.3.2.

Safety
Conformity with applicable safety requirements of the EU Directive concerning Low Voltage for the SimMan 3G system have been based on compliance with the relevant safety requirements defined by EN 609501:2005. Manufacturers of peripheral components of the SimMan 3G system have independently declared compliance the safety requirements of the EU Directive concerning Low Voltage and are eligible of carrying the EC mark. Conformity with relevant safety standards recognized by Canadian and US regulatory bodies have been demonstrated through (c) CSA (us) certification of peripheral components in the SimMan 3G system. Applicable Regulations: EU Directive, 2006/95/EC, Low Voltage 29 CFR 1910.301 - Occupational Safety and Health Standards Electrical Safety Canadian Electrical Code, CAN/CSA 22.x Relevant Safety Standards: EN 60950-1:2006 - Information Technology Equipment Safety UL 60950-1 - Standard for Safety Information Technology Equipment CAN/CSA-C22.2 No. 60950-1 - Information Technology Equipment Safety

Page 7 of 127

TSM Draft

1.3.3.

Electromagnetic Compatibility (EMC)

Conformity with applicable protective requirements of the EU Directive concerning EMC has been demonstrated by compliance with relevant harmonized standard. SimMan 3G is intended for use in the electromagnetic environment specified in the tables below. Applicable Regulations: EU Directive, 2004/108/EC, EMC

1.3.3.1.

Electromagnetic Immunity
IMMUNITY TEST COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE SimMan 3G may sometimes be susceptible to interference from other RF communication equipment interfere. In such instances increase the distance between the SimMan 3G and interfering RF transmitters. Observe precautions for handling of electrostatic sensitive devices during service and maintenance of the manikin.

RF Electromagnetic Fields

80-2000 MHz 3V/m (CP) 1kHz 80% AM modulation

Electrostatic Discharge

4kV contact* 8kV Air

* NOTE: Compliance level measured with manikin assembled and covered by simulator skins.

Relevant Technical Standards: EN 61000-4-2, Electrostatic discharge immunity tests EN 61000-4-3, Radiated, radio-frequency, electromagnetic field immunity tests

1.3.3.2.

Electromagnetic Emission
EMISSION TEST COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE SimMan 3G use RF energy only for its internal function. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronics equipment.*

Conducted emission

0.15 MHz 1GHz EN3014891 TestMethod:EN 55022 Equipment class B

Radiated emission

Harmonic Current Emission

Test method and limits: EN 61000-3-2

Voltage Fluctuation and Flicker

Test method and limits: EN 61000-3-3

Page 8 of 127

TSM Draft
* NOTE: Intended radiation from RFID reader and WLAN adapter should be taken into consideration when determining a suitable environment for SimMan 3G to be operated. See Section Radio Frequency Communication.

Relevant Technical Standards: EN 301 489-01/03/17, EMC standard for radio equipment and services; Part 1: Common technical requirements EN 55022, Information technology equipment. Radio disturbance characteristics. Limits and methods of measurement EN 61000-3-2, Limits for Harmonic Current Emission EN 61000-3-3, Limitations of voltages changes, voltage fluctuations and flicker

1.3.4.

Radio Frequency Communication

SimMan 3G Radio Frequency Communication system incorporates; Radio-frequency identification (RFID) receiver/antennas, and; Wireless Local Area Network (WLAN) adapter.
Operating Frequency [Hz] Maximum Radiated Transmitting Power [Watt] RFID WLAN 13.56 MHz 2.412 ~ 2.484 GHz (Channels 1-11) 802.11 b/g/n Technical Specifications 1W 0.1 W < 0.2 m < 100 m Operating Range [meter]

RADIATION TEST

COMPLIANCE LEVEL

RADIO FREQUENCY COMMUNICATION ENVIRONMENT GUIDANCE GENERAL Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

RFID Transmitter class 1 Receiver class 3 Antenna type 1 WLAN

42 dBuA/m @ 10 m 13.553 to 13.567 MHz Duty cycle: Up to 100%

20 dBm @ 3m 2.4000 2.4835 MHz WLAN Thisequipmentshouldbeinstalled andoperatedwithminimumdistance 20cmbetweentheradiator&your body.

Applicable Regulations: EU Directive, 1999/5/EC, Radio and Telecommunications Terminal Equipment (RTT&E) 47 CFR Part 15 Radio Frequency Devices (FCC)

Page 9 of 127

TSM Draft 1.3.4.1. European Directive 1999/5/EC RTT&E

SimMan 3G complies with the essential requirements of the EU Directive concerning RTT&E. Manufacturers Declaration of Conformity is included in SimMan 3G Directions for Use. WLAN adapter is declared by manufacturer (Gigabyte) to be in compliance with RTT&E Directive and CE marked as an individual component. Relevant Safety Standard: RFID: EN 300 330, Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Short Range Devices (SRD) (9 kHz to 25 MHz) WLAN: EN 300 328, Electromagnetic compatibility and Radio spectrum Matters (ERM);Wideband Transmission systems (2,4 GHz ISM band) WLAN - SPECIAL CONSIDERATIONS SimMan 3G will carry Class 2 equipment identifier for WLAN. Countries in which SimMan 3G may be used freely: Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden Switzerland and UK Countries where usage of SimMan 3G is limited: France: The use of other WLAN channels than the channels 10 through 13 is prohibited by local legislation.

1.3.4.2.

47 CFR Part 15 Radio Frequency Devices

SimMan 3G is verified to comply with applicable requirements of 47 CFR Part 15.225. The measured RF emission of SimMan 3G is found to be within the limits defined by Part 15.209: Maximum Allowed Field Strength from an intended radiator (1.705~30 MHz): 30 microvolts/meter @ 30 meters. FCC ID: QHQ-212-00001 WLAN adapter installed in SimMan 3G has a separate FCC modular approval. SimMan 3G is labeled with the FCC ID shown below. Contains FCC ID: JCK-GN-WB31N-RH FCC APPROVAL - SPECIAL CONSIDERATIONS Federal Communications Commission Statement This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Page 10 of 127

TSM Draft
Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

1.3.5.

Transportation
Transportation of Lithium batteries is regulated through different regulations. Among the most prominent is the two regulations listed below. The rechargeable Lithium Ion Battery Pack installed in SimMan 3G has found to comply with applicable requirements of UN Manual of Test and Criteria.

Relevant Regulations UN Manual of Test and Criteria, Part III - Sub Section 38.3 - Lithium Batteries 49 CFR Part 173.185 - Lithium batteries and cells NOTE: Additional local regulations for transportation may apply for transportation of Lithium Batteries. Inform transport agency about product containing Lithium batteries.

Page 11 of 127

TSM Draft

2.

TOUR OF THE SIMULATOR 2.1. External Connections and Vascular Access

Defibrillation Connections Sternal IO Module

IV Catheter LAN (Ethernet) Power Supply

BP Cuff Refill Unit Blood Compressor /Regulator /CO2 bottle Refill Unit Fluid Intra Muscular Injection (IM Pad)

: ECG Connections (4) : IM Pad (right buttock) Tibial IO Module

Fig. 1

Page 12 of 127

TSM Draft

2.2. Overview for Blood and Fluid Outputs

Fluid port, sweat Fluid port, eyes Fluid port, nose Fluid port, ears (both ears) Fluid port, mouth Blood port 1 Blood port 2

Blood port 3

Blood port 4 Urinary port

(internal)

Fig. 2

Page 13 of 127

TSM Draft

2.3. Overview Pulses

Carotid Pulse (Right)

Carotid Pulse (Left)

Brachial Pulse (Left) Radial Pulse (Right) Femoral Pulse (Right) Radial Pulse (Left) Femoral Pulse (Left)

Dorsalis Pedis (Right) Posterior Tibial Pulse (Right)

Fig. 3

Dorsalis Pedis (Left) Posterior Tibial Pulse (Left)

Popliteal Pulse (Right) Popliteal Pulse (Left)

Fig. 4

Page 14 of 127

TSM Draft

2.4. Internal System Overview

Head Manifold Head Board

Jaw Antenna

Eye Modules

Compression module Lung modules Flowmeter Position sensor IV Arm Antenna RFID Sub assembly
- Antenna select Board - Drug. Reg Board and
+ + -

Base Board System on Module (SoM) PC Card WLAN Dongle

M M

Convulsion motor Air distr. unit

Fluid Manifold Convulsion motor

Valve Board

Fluid tank w/Blood and Fluid Bags

Batteries

Compressor
M

Compressor Board

Fig.5

Page 15 of 127

TSM Draft

2.5. Speaker and Sound System Overview

Figure 6 illustrates Heart sounds locations: 1. 2. 3. 4. 5. RUSB Aortic LUSB Pulmonary LLSB Tricuspid Apex Mitral BP (Blood Pressure)

Fig. 6

Figure 7 illustrates Bowel sounds locations:

Fig. 7

Page 16 of 127

TSM Draft

Figure 8 illustrates the two microphones located in the ears, and the vocal speaker in the head. Vocal speaker Microphone (2)

Fig. 8

Torso Anterior (front) is illustrated with lung speakers in Figure 9:

1 3 4

1. 2. 3. 4. 5.

RU LU RM RLL LLL

Right Upper Lobe Left Upper Lobe Right Middle Right Lower Lobe Left Lower Lobe

Fig. 9

Torso Posterior (back) is illustrated with lung speakers in Figure 10:

6 7. 8. 9. 10. 11.

LU RU LM RM LL RL

Left Upper Lobe Right Upper Lobe Left Middle Lobe Right Middle Lobe Left Lower Lobe - Right Lower Lobe

Fig. 10

Page 17 of 127

TSM Draft

3.

FUNCTIONAL DESCRIPTION

3.1. General Overview, Functions & Electronics

The SimMan 3G Simulator has the following electronic & functions, illustrated in Fig. 11 and Fig. 12:

TORSO 1) Defib sternum 2) Compression detection (depth and rate) 3) Sternal IO 4) Pneumathorax 5) ECG 6) Lung Compliance 7) Lung Resistance 8) Ventilation 9) 11 x Lung Speakers 10) 4x Heart Speaker 11) System on Module (SoM) PCcard

RIGHT 1) 2) 3) 4) 5) 6) 7)

LEG ECG Right Leg Fluid Bag Popliteal pulse Pressure Tank Leg PCB Compressor/pump Cooling fan??

PELVIS 1) 2) 3) 4) 5) 6) 7) 8) 9) 10)

USB WLAN dongle Right Lung Speaker (lower) Left Lung Speaker (lower) Defib Apex 4x Bowel sound Fluid Manifold Pneumatics Manifold Valveboard PCB 2x Femoral pulse IM Pad

LEFT LEG 1) ECG Left Leg 2) Popliteal pulse 3) Tibial IO

RIGHT FOOT 1) Pedal pulses

LEFT FOOT 1) Pedal pulses

Fig. 11

Page 18 of 127

TSM Draft

HEAD 1) 2) 3) 4) 5) 6) 7)

2x Eye module: Active eyes w/lids pupils responding to light Head speaker Head control card Head manifold Jaw Antenna Board 1 x Antenna for airway event registration Trismus bladder

NECK 1) 2)

2x Carotid pulse Neck potentiometer, for registration of neck position

RIGHT ARM 1) 4x Antennas for Drug registration 2) IV module PCB 3) Right Radial pulse 4) Convulsion Right Arm

LEFT ARM 1) Brachial pulse 2) BP speaker 3) Left Radial pulse 4) Convulsion Left Arm

Fig. 12

Page 19 of 127

TSM Draft

3.2. Compression System

The depth and speed of CPR are measured using optoelectronics. The main parts are: 1. Opto Switch 2. Depth gauge 3. Label on depth gauge 4. Compression spring

Fig. 31

Fig. 32 On the depth gauge there is placed a label with a pattern on it. The pattern has a period of 0.916mm, where the black stripes are 0.487mm wide and transparent parts are 0.429mm wide. When you perform CPR, the opto switch read the pattern and then calculates the depth.

Page 20 of 127

TSM Draft

Fig. 33

On the depth gauge there is placed a label with a pattern on it. The pattern has a period of 0.916mm, where the black stripes are 0.487mm wide and transparent parts are 0.429mm wide. When you perform CPR, the opto switch read the pattern and then calculates the depth. The opto switch has two channels, A and B. it will always be 90 degrees phase lead between them, and by checking (in software) which channel is first, you can tell the direction of the movement.

Page 21 of 127

TSM Draft

3.3. Lung module

Fig. 34 The two lungs are placed in the torso, and they are used when baging the manikin. They can be set to have different compliance and restriction settings. The change of compliance will make the lung feel more/less stiff when baging, and restriction will simulate narrowing passage of air to the lungs. There are two air in/out. One (the biggest) for air that is coming from the airway when baging. The other one (small) goes into a pressure sensor on the valveboard for reading the pressure in the lung. This value will be converted to a signal used to control chest rise.

Fig. 35

Page 22 of 127

TSM Draft

3.3.1.

Compliance

When activating the compliance you activate one or both solenoids which will hook the spring(s). There are four settings: 1. 2. 3. 4. No springs are hooked Left side spring is hooked Right side spring is hooked Both springs are hooked

When baging and compliance are activated, the spring(s) will hold the lung plate upper, and make it harder to get air into the lungs. The two springs are different in strength and therefor number 2 and 3 will give different feedback when baging.

Hook Fig. 36

Spring

Solenoide

Page 23 of 127

TSM Draft

3.3.2.

Restriction

When changing the restriction setting, the stepper motor will rotate and then turn on lung valve cylinder. The lung valve cylinder has four positions: 1. 2. 3. 4. Fully open Increased High resistance Closed

This way you change decrease/increase the airflow into the lung when baging.

Air in/out

Pressure movement

Stepper motor Fig. 37

Lung valve cylinder

Page 24 of 127

TSM Draft

3.4. CO2 System

A separate CO2 tank connects to the existing SimMan compressor. Air and CO2 are routed from compressor to SimMan 3G Air/CO2 inlet. Inside SimMan 3G air and CO2 are routed in separate tubes to the air distribution unit in pelvis.

Fig. 38

Fig. 39

SimMan Compressor:

Regulatorbox:

Fig. 40

Fig. 41

Page 25 of 127

TSM Draft

3.5. Bleeding & Fluid System

The figure illustrates the concept description for the bleeding- and secretion simulation:

Air pressure in Blood out (venous) Valve Blood out (arterial) Valve Pressure Tank Bag with simulated blood Flow meter

Tubing

Fluids out Bag with other fluids Valve

Fig. 42 Warning: Compressor has to be OFF when filling fluid to the tank.

Page 26 of 127

TSM Draft

3.5.1.

Bleeding System Pelvis

Fig. 43

Page 27 of 127

TSM Draft

3.5.2.

Fluid distribution Unit Pelvis

Fig. 44

Page 28 of 127

TSM Draft

4.

FUNCTIONAL VERIFICATION
This functional verification helps to confirm the proper operation of the SimMan 3G manikin and options.

4.1. Battery Operation

Fig. 13 Power Save* Charge Error** Almost complete*** No charge**** - Blinking light - One or both batteries missing - Not recommended to charge the batteries for too long - Because of no power input, or that batteries are fully charged. If the manikin is charged from a low-voltage source, running and charging the manikins is not possible simultaneously.

4.2. Battery Change

When the remaining capacity is > 5% in the battery which is still connected, it is the same which one of the two batteries to be changed.

4.3. Battery Capacity and power down of manikin

If one of the batteries has 5% below remaining capacity regardless of the other, the manikin will power down.

4.4. Battery Heat Warning

If a Heat warning occurs the battery needs to cool down, no need for reset of the battery.

Page 29 of 127

TSM Draft

4.5. How to Access the Test Utility Program

1. 2. 3. Establish connection with manikin (WLAN or cable) Start Remote desktop connection via Start Menu: All programs Accessories Remote Desktop Connection Enter IP address to connect and click options to enter details, see figure: LAN 192.168.169.2 WLAN 192.168.170.1

IP address or the manikins name

Fig. 14 Log in: Administrator Password: SimMan3G (if required) 4. 5. 6. 7. 8. 9. 10. Click Connect Now you will see the Remote Desktop of the SimMan 3G (this can take a while) Double click Stop Update Service This will stop the manikins control program. Double click on SimMan 3G Test Utility Just click connect in the Connect to Manikin window Then you will access the Test Utility program, and after a few seconds the manikin will start breathing NOTE: If the simulator will be turned off, you have to exit the Test utility via remote desktop and click Start update service

Page 30 of 127

TSM Draft

4.6. Test Utility Program

4.6.1.

Head

Fig. 15 Sent and Received packages This indicates there is communication internally in manikin Lost packages May happen and will indicate if any communication is lost (high number could indicate problems) a. Blink i. ii. iii. b. Eyelid i.

Blink eyes manually activate a blink Left/Right eye choose one or both Auto and seconds - set the seconds between each blink position You can set the eyelid position in three different positions; Open, Half open or closed ii. Choose which eye you want to test c. Iris size/mode

Page 31 of 127

TSM Draft
i. Check the iris size with choosing different sizes auto/ manual/reduced speed ii. When both eyes (Left and Right) are selected check the synchronization of the iris size iii. Light sensor value indicates incoming light d. Iris adaption i. Direct sets the aperture for direct light ii. Normal sets the aperture in ambient light iii. No light sets the aperture in no light e. Reset i. Calibrate calibrate the eyelid position ii. Reset You can reset eyelid/iris f. Jaw trust/Neck tilt i. Jaw sensor value - Observe the jaw trust function by thrusting the jaw ii. Neck sensor value - Check the neck sensor by tilting the neck g. Complications - you can observe the different functionalities and check for various settings for the following functions, the value indicates the amount of the complication (100=max): i. DCRM ii. Laryngospasm iii. Pharyngeal iv. Tongue v. Trismus vi. Cyanosis h. Iris offset adjustment input from Jan Arild i. Left Eye Constricted ii. Right Eye Constricted iii. Left Eye Dilated iv. Right Eye Dilated i. Events lists the recent events

Page 32 of 127

TSM Draft

4.6.2.

Arm

Fig. 16 j. DrugEvent i. Arm tagid; place one RFID tag in the right IV arm catheter area (max 0.2m from catheter) and observe the tag id is detected in the Arm tagid window ii. Head tagid; place one RFID tag in the jaw area and observe the tag id is detected in the Head tagid window (max 0.2m from jaw) iii. Injected vol (L); inject 10 ml distilled water in the IV catheter and read the given volume. If the volume given differ more than 10% from the volume detected, go to Test tab and initialize and calibrate the flow meter

k. Convulsions i. Convulsions left (RPM); test the motors in the convulsion module for different settings and observe the convulsions in the left arm ii. Convulsion right (RPM); test the motors in the convulsion module for different settings and observe the convulsions in the right arm iii. Check if the same setting in both arms gives similar convulsions

Page 33 of 127

TSM Draft

4.6.3.

Valve

Fig. 17 Bleeding/fluid i. Bleeding strength; you can choose what strength you want to test in either port 1 and/or 2, or ports 3 and/or 4. Then you can test either arterial or venous bleeding. 1. In this window you can read the amount of blood volume given and the flow. 2. Tank status will give you the current status. 3. Bl. Hose press. Will give you the pressure in the blood reservoir b. Check for fluid on/off in the different areas: ii. Nose iii. Ear iv. Mouth v. Eye vi. Urine vii. Froth viii. Sweat c. Stomach valve a. Closed will inflate stomach bladder if ventilation is done too fast or with too much force b. Open stomach bladder will deflate d. Airway complications i. Resistance check for the normal/increased/high/closed settings ii. Compliance check for normal/level 1/level 2/ level 3 iii. Pneumathorax check both bladders at max l.

Page 34 of 127

TSM Draft

4.6.4.

Leg

Fig. 18 In this window you can check the pressure in the compressor, and if it is ON or OFF. The regulation mode indicates if Manuel or Automatic pressure regulation. Caution: In manual mode the compressor will run continuously until it is stopped manually.

Page 35 of 127

TSM Draft

4.6.5.

Vital signs

Fig. 19 a. Breathing function: i. Breath rate: set a breathing rate and check if it is correct ii. Breathing strength: set the breathing rate for Normal, X or Y iii. Apnea - If you choose apnea the simulator should stop breathing. Use this when doing ventilation. b. BP/HR: i. BP Sys set the blood pressure systolic pressure ii. BP Dia set the blood pressure diastolic pressure iii. Heart rate set the heart rate

Page 36 of 127

TSM Draft

4.6.6.

Sounds

Fig. 20 a. b. c. d. e. f. Lung sounds set the sound and volume for the different speakers Vocal Set the volume level for the vocal sounds Link this links all settings to all speakers Heart sound set the sound and volume for the different speakers Link this links all settings to all speakers Bowel sounds - Set the bowel sound and volume - Repeat bowel sounds with adjustable delay (set in seconds) g. BP Cuff i. Auscultation Gap Jan Arild ii. Ascultate Jan Arild

Page 37 of 127

TSM Draft

4.6.7.

Comp/Vent

Fig. 21

4.6.8.

Pulses

Fig. 22 a. Check for detection when doing palpation for the different pulses b. Check for you feel the pulses

Page 38 of 127

TSM Draft 4.6.9. Versions

Fig. 23 a. No data received indicates if disconnected or faulty board b. Lists of the different versions of the circuit boards and its software version, in the manikin c. Reset Node Communication A reset will reread the versions

4.6.10. Power

Fig. 24 a. Battery status indicator page

Page 39 of 127

TSM Draft 4.6.11. Defib/Pacing

Fig. 25

a. Defib i. Defib energy measured energy ii. Defib type b. Pacing i. Pacing threshold level for pacing capture

Page 40 of 127

TSM Draft 4.6.12. Test

Fig. 26 a. Reset b. RS495 Node Comm. ii. Reset Node Communication iii. Read Sumlog c. Calibration iv. Calibrate BP Cuff calibrate if necessary v. Calibrate Valve Board calibrates offset vi. Calibrate Stomach If calibration needed apply 56cmH2O to esophagus and stomach sensor vii. Init Flow Sensor if flow meter is stuck use this to reset the piston in flow meter, follow instruction viii. Calibrate Flow Sensor follow instruction d. Debug for test purpose only ix. Antenna sel manual mode x. RFID xi. IV Flow meter Configuration xii. Flow meter piston position xiii. Invert direction xiv. Enable reading e. IV Board Power Save Mode xv. Get Power Save Mode

Page 41 of 127

TSM Draft 4.6.13. Bootloader

Fig. 27 a. Bootloader manually updating of node boards (Manikin Update is to be preferred)

4.6.14. Autotest

Fig. 28 Autotest

Page 42 of 127

TSM Draft 4.6.15. Debug

Fig. 29

b. Debug i. Start Log ventilation data ii. Start Log compression data

Page 43 of 127

TSM Draft

4.7. Manikin statistics

For a statistic report of the actual manikin: Toolbar Tools Maintenance Manikin Statistics The report gives the status of the use of the manikin for some of the components and systems. Ex.

Fig. 30

Page 44 of 127

5.

INTERCONNECTION SYSTEM
5.1 Cable Connections Between the Circuit Boards

Following schematics and figures are representing the total infrastructure and interconnection system in the manikin.

Page 45 of 127

5.2. Base Board Cable Connections

Page 46 of 127

5.3. Head Board Cable Connections

Page 47 of 127

5.4. Valve Board & Lung Board connections

Page 48 of 127

5.5. Cables

Page 49 of 127

5.6. Compressor Board connections

Page 50 of 127

5.7. Drug Registration Board

Page 51 of 127

Page 52 of 127

5.8. Tubing in Head, Air Distribution

Page 53 of 127

TSM Draft

6.

EXPLODED VIEWS

Following figures illustrates Exploded views of the different parts and modules in the manikin. NOTE: The BOM reference numbers on the illustrated pages are NOT spare part numbers that can be ordered. The drawings and numbers are for illustration only. Please refer to the pages XX YY for Replacement & Service Parts.

Page 54 of 127

TSM Draft

6.1. Head Assembly

Page 55 of 127

TSM Draft

6.2. Skull Lower Assembly

Page 56 of 127

TSM Draft

6.3. Eye Assembly

Page 57 of 127

TSM Draft

6.4. Airway Assembly

Page 58 of 127

TSM Draft

6.5. Neck Assembly

Page 59 of 127

TSM Draft

6.6. Torso Assembly

Page 60 of 127

TSM Draft

6.7. Torso (w/pelvis) Assembly

Page 61 of 127

TSM Draft

6.8. Torso (back)

Page 62 of 127

TSM Draft

Page 63 of 127

TSM Draft

6.9. Torso

Page 64 of 127

TSM Draft

6.10.

Torso Base plate Assembly

Page 65 of 127

TSM Draft

6.11.

Torso Base plate Assembly

Page 66 of 127

TSM Draft

6.12.

Torso Base plate Assembly

Page 67 of 127

TSM Draft

6.13.

Back Cover Assembly

Page 68 of 127

TSM Draft

6.14.

Chest Assembly

Page 69 of 127

TSM Draft

6.15.

Compression Plate Assembly

Page 70 of 127

TSM Draft

6.16.

Compression Spring Assembly

Page 71 of 127

TSM Draft

6.17.

Thorax Right Assembly

Page 72 of 127

TSM Draft

6.18.

Thorax Right Assembly

Page 73 of 127

TSM Draft

6.19.

Thorax Right Assembly

Page 74 of 127

TSM Draft

6.20.

Thorax Left Assembly

Page 75 of 127

TSM Draft

6.21.

Valve Board Protection Assembly

Page 76 of 127

TSM Draft

6.22.

Power Panel

Page 77 of 127

TSM Draft

6.23.

Fluid Panel

Page 78 of 127

TSM Draft

6.24.

Pelvis Assembly

Page 79 of 127

TSM Draft

6.25.

Pelvis Mechanical Assembly

Page 80 of 127

TSM Draft

6.26.

Stomach Assembly

Page 81 of 127

TSM Draft

6.27.

Leg Right

Page 82 of 127

TSM Draft

6.28.

Pressure Tank

Page 83 of 127

TSM Draft

6.29.

Lower Right Leg

Page 84 of 127

TSM Draft

6.30.

Compressor

Page 85 of 127

TSM Draft

6.31.

Left Arm, BP Arm

Page 86 of 127

TSM Draft

6.32.

Left Arm w/pulse

Page 87 of 127

TSM Draft

6.33.

Right Arm, IV Arm

Page 88 of 127

TSM Draft

6.34.

Flow meter Assembly (Right Arm)

Page 89 of 127

TSM Draft

6.35.

IV Arm w/Antenna

Page 90 of 127

TSM Draft 7.

NETWORKING AND COMMUNICATION SYSTEM

The SimMan 3G and system will allow operators anywhere on a network to control a SimMan 3G simulator anywhere on the same network: Allow operators to control and monitor a simulation via Internet access (provided sufficient access) Allow multiple simulations to be controlled from a single computer Allow multiple instructors to observe/control the same simulation

7.1. Networking Overview

Intranet

Page 91 of 127

TSM Draft

7.2. Communication System

The figure is an illustration of the Communication Framework implemented in the Baseboard application that communicates with the server software in the System On Module (SOM) and with the devices on the I2C bus.

Figure X: Overview of the communication system The Baseboard has two communication links for communication with other devices: Ethernet: Communication channel for talking with server software on System on Module (SOM) RS485 bus: Communication channel for embedded node devices

Figure X: Internal communication flow on the Baseboard

Page 92 of 127

TSM Draft

ATTACHMENT 1 NEED REVIEW!!!

SimMan 3G Simulator Final Service Test Check List

Tool: Test Utility (Remote Desktop) SimMan 3G Serial number: ________________

TEST
Head/Neck Assembly: Inspect head skin for overall appearance Perform direct laryngoscope, inspect: epiglottis, vocal cords, upper trachea, esophageal area for damage, rupture or leakage. Inspect teeth and neck assembly for overall appearance Airway/Breathing - Decreased Cervical Range of motion - Trismus - Pneumothorax left/right - Inflation - pressure detection - Lung pressure detection - 4 level left/ right airway resistance - Pharyngeal swelling - Laryngospasm - Tongue edema - swollen tongue (2 levels) - Exhale CO2 - 4 level lung compliance - Stomach distension - Controllable open/closed airway; automatically or manually controlled - Stomach pressure detection - Head tilt/chin lift - Jaw thrust w/articulated jaw - Detection of proper head position - Bag-mask ventilation - Esophagus/esophagus pressure detection Confirm variable respirations are present when increased/decreased from test utility Confirm apnea causes no breathing when

PASS/FAIL

Page 93 of 127

TSM Draft When simulator producing spontaneous respirations, confirm presence of respiratory sounds from simulators Confirm presence of capnograph waveform on patient monitor to match each respiratory cycle Chest Movement: Confirm detection in test utility of: - Single precordial thump? - CPR compressions - Bag-valve-mask while ventilating Confirm that CPR artifacts is being produced on the patient data display monitor when chest compressions are being performed Right leg Assembly: Inspect skin for holes or damage Inspect leg-to-pelvis attachment (thigh joint connectors, connectors for tubes and cables) to allow correct movement Inspect ankle joint Inspect handler for tank drain valve Torso Assembly: Inspect skin for overall appearance. Check that that ECG studs and defib. connectors are clean. - Chest drain pleura in place, left - Chest drain pleura in place, right Inspect for overall external appearance Ensure head assembly-to-torso hardware is tight and that head rotates freely from side to side and forward and backward. Inspect chest plate for overall appearance and free movement into and out of torso cavity Inspect torso-to-pelvis attachment screws. Each should be properly secure (check with screwdriver). Pelvis Assembly: Inspect for overall appearance Right arm Assembly: Inspect skin for holes or damage. Inspect arm-to-torso attachment screw to allow full articulation. Left arm Assembly Inspect skin for holes or damage. Inspect arm-to-torso attachment screw to allow full articulation Power Panel (Right side) Page 94 of 127

TSM Draft Check connectors and cables for damage and for easy connection to mating parts Fluid Panel Check connectors for damage and for easy connection to mating parts Sound (BP) Confirm presence of BP sound in left arm. Sound should be present at set systolic pressure and diminish to absent at diastolic. SpO2: Verify that the red light is illuminated on the probe when the unit is plugged into the Patient Monitor. Confirm that when the SpO2 probe is plugged in and not on SimMan3G finger, there is no waveform or numerical value produced on the patient data display monitor. Confirm that when the SpO2 probe is plugged in and on SimMan3G finger, a waveform or numerical value is produced on the patient data display monitor. ECG and Electrical Therapy: Confirm presence of ECG at lead and at hands free (sternum and apex). White lead on patients right shoulder, black lead on patients left shoulder and red lead on patients left lower torso. With running rhythm set at VF, waiting rhythm at NSR, and ignore shock is active, confirm that defibrillation at 360J WILL NOT move waiting to running rhythm. Three (3) shocks at the defibrillators maximum Joule (minimum 200J) are to be delivered as rapidly as possible. With running rhythm set at VF, waiting rhythm at NSR, and shock enabled, confirm that defibrillation at a minimum of 50J WILL move the waiting rhythm to the running rhythm. With the running rhythm set at NSR at 40, and pacing disabled, confirm that pacing at 200mA WILL NOT capture With the running rhythm set at NSR at 40, pacing threshold set at 40mA, and pacing enabled, confirm that pacing greater then 80mA WILL produce capture and create a pulse rate matching that set on TCP device. Eyes - Wide open - Closed Page 95 of 127

TSM Draft - Partially open - Normal speed of response to light - Sluggish speed of response to light - Pupil diameter automatically responds to light: Synchrony/asynchrony - Blinking - Normal - Winks Breathing - Simulated spontaneous breathing - synchronized with respiration rate - Normal and abnormal breath sounds - 5 anterior auscultation sites - 6 posterior auscultation sites - Unilateral & lobar breath sounds - Oxygen saturation & Plethysmogram - Bilateral and unilateral chest rise and fall - linked to airway complications settings - CO2 exhalation - linked to the student action of measuring CO2 Cardiac - 12 lead dynamic ECG display - Extensive ECG library with rate from 0-220 - Heart sounds four anterior locations Circulation - Pulses synchronized with ECG - Posterior tibialis - Dorsalis - Popliteal - Femoral Left - Femoral Right - Radial - Brachial - Carotid - Checkpoint: relative pulse strength (peri vs. central) - Pulse strength variable with BP Other - Head sounds - Head microphone Page 96 of 127

TSM Draft - Convulsions - Patient Voice/Throat Sounds - Custom sounds - Pre-recorded sounds played - Instructor can simulate patients voice wirelessly - Bowel Sounds speaker in each quadrants - Bleeding - Integrated system allows simulation of bleeding throughout manikin - Arterial and venous - Secretions from eyes, ears, nose, mouth, forehead, urinary output - Blood, Mucous, CSF, etc. - Urine output variable - Instructor communication Multiple instructors can communicate using integrated voice over IP communications - Cyanosis CPR: Compliance with 2005 Guidelines - CPR compressions generate palpable pulses, Blood pressure wave form, and artifacts on ECG - Realistic depth of compressions (6 cm) - Detection of depth and frequency of compressions - Detection of leaning - Real time feedback on quality of CPR - Hand position detection - Defibrillation and cardioversion - Pacing - Reading of cardiac rhythms via 4 connector 3-lead ECG monitoring Circulation - Palpation is detected & logged - Vital signs automatically respond to bleeding & therapy (Auto Mode only) - BP measured manually by auscultation of Korotkoffs sound (left arm) - Tibial IO module in place - Sternal IO module in place

RFID detection - Automatic drug recognition system identifies drug within the specified IV area & measures dose - Automatic drug recognition system identifies actions Page 97 of 127

TSM Draft within the specified jaw area

Other - Bleeding treatment (bandage, pressure point, tourniquet, pliers) - Urine Catheterization (Foley) - Connect fluids from external sources - Debriefing functionality - Webcam integration - Debrief Viewer Test Performed by: ______________________ (Print name) ______________________ (Signature) Date:________

Page 98 of 127

TSM Draft

ATTACHMENT 1

Service Parts- SimMan 3G

Head and Neck

Cat. no BOM Photo Description

21260150

S21222

Jaw Assy Complete

21260250

S21223

Eye Assy Complete

21260350

Shroud Assembly w/screws, bladders and tubes Need new photo

21260450

1007014

Head speaker Assembly

Page 99 of 127

TSM Draft

21260550

N0691 N0692 N0693 1483 (9)

Skull upper and skull lower mated

21260650

N0831

Head foam w/adhesive

21260750 21260850

N0696 N0695 N0819 (4) 6525-080001

Eye holders (right and left) w/screws

Magnetic sensor jaw

21260950

1005020 1463 (2)

Lower teeth w/screws

21261050

FST1011

SAPS Head Board (NOTE: comes without air distribution unit and tubes)

21261250

N0739

Cable, Power and Signal

21261350 N1003 212N0620

CAROTID
L

Cable, Carotid Pulses Air distribution unit Head

Page 100 of 127

TSM Draft
61450

21261550 N1116 Cable Microphone

21261650 21261750

N1187

Y Cable microphone

N0977 (10)

Plug (ear)

21261850

N1186

Y Cable blue lips

21262150

N0724 N0722

Neck Potentiometer and Neck Plate

21262250 21262350 N0738

Neck Assembly

Cable, Headboard to Eye

21262450

S21221 N1114

Head Skin Assy w/airways Froth filter

Page 101 of 127

TSM Draft
21262550

21262650

N1031

Barb to barb orifice (pkg 5)

Page 102 of 127

TSM Draft

Torso

21272050

N1000

Cable, Baseboard to USB WLAN module

21272150

N1033

Gasket, Base plate

21272250

N1025

Foam, Thorax Speaker

21272450

N1023

Cable, Baseboard to compression sensor

21272550

N1024 N0837

Switch, Correct hand position switch (w/foam)

21272650

N1008

Speaker cable, Lung and Heart

21272750

N1020

Speaker cable, Lung back assembly

21272850 21272950

N1007 N1027

Cable, Chest speaker extension cable Foam, Chest Speaker

Page 103 of 127

TSM Draft

21273050 TBD 21273150 TBD 21273250 TBD 21273350 TBD 21273450

N1036 N1159

Foam, Chest top left & right

8767 (10) Need Photo 2707 (10) Need Photo 2995 (10) Need Photo 2708 (10)

ECG connector Defib. connector Connection Peg ECG Connection Peg Defib

21273550 21273650

N1021

Cable, ECG from baseboard

N1022 21273850 21273950 21274050 21274150 21274250 21274450 21274450 Need photo FST1009 N0968 N0969 N0984

Cable, ECG to defib sternum SAPS Base Board Cable, Baseboard com. to Head Cable, Baseboard com. to Valve Board Cable, Baseboard com. to Right Arm Cable, Baseboard On/Off switch Need Photo Cable, Baseboard to external Ethernet Cable, Baseboard to External Power

N0993 N0994 N0995

Need Photo

Page 104 of 127

TSM Draft

21274550

N0999

Cable, Baseboard to Battery

21274650

N1001

Cable, Pulses from Baseboard

21274750

N1006

Cable, Speaker from Baseboard harness

21274850

7020 (10)

Port in for BP cuff (pkg 10)

21274950

N1065

Fan, axial 60x60x25

21275050

N1125

Antivibration Kit (for fan) Gap pad (between a CPU and heat sink)

21275150

N1188

Need Photo

21275250 21275350 21275450 21275550

N1247

Cable, Compression sensor output

N0659 (10) FST2010 Need Photo

Cable clip Kit (pkg 10) Board, Lung Connection

N0870

Cable, Compliance Solenoid

Page 105 of 127

TSM Draft

21275650 21275750 21275850 TBD 21273850

N0882

Stepper motor resistance valve

N0883 Need Photo S21234 Need Photo 2154 (4) Need Photo FST1009

Optical switch Compression Assy Pulse Unit (pkg 4) Base Board, SimMan 3G

21276050 21276150 S21233 21276250 KID3154

Need better Photo Need Photo

Back cover Assy complete

Lung Assy Complete Need Photo Board, Lung connection

21276350 21276450 21276550

N0872 N0873 Need Photo S21233 Need Photo N1262

Compliance activator spring (left and right) Lung Valve Assy

Compliance Activator Assy

Page 106 of 127

TSM Draft

Pelvis

212-68050

N1101 (10)

Blood port connector (pkg 10)

212-68150

N1017

Speaker cable, Bowel assembly

212-68250

N1109

Stomach valve

212-68350 212-68450 Check if already existing Cat. # 212-68550 Check if already existing Cat. #

N1040

Stomach foam

1005066 S

Pad Assy femoral pulse left side

1005065 S

Pad Assy femoral pulse right side

212-68650

N1011 Panel base right

212-68750 N1010 Panel base left

Need photo 212-68850 FST2024 Panel board

Page 107 of 127

TSM Draft

212-68950

N0997 (5)

On/Off switch (pkg 5)

212-69050

N1092 (10)

Air/ CO2 connector (pkg 10)

212-69150

N1103 (10)

Fluids fill port (pkg 10)

212-69250

N1250

Double-sided tape (roll)

N0619 212-69350 Air distribution unit pelvis

212-69450

N1266 (10)

Air tank connector male (pkg 10)

VSO Valve assembly (for chest 212-69550 N1100 rise)

N0777 212-69650 Fluid distribution unit

212-69850

N1198 (10)

Fluid tank connector male (pkg 10)

212-69950 N1201 (10) N1096 (5) Fluid tank connector female (pkg 10) Check valve fluid (pkg 5)

212-70050

Page 108 of 127

TSM Draft

212-

N1031 (5)

Barb to barb orifice

N1265 212-70250 Mani foil pelvis

212-70350

FST1010

Valve Board Cable Valve Board com. to Right

212-70450

N0992

Leg

212-70550

N1102

Proportional valve

212-70650 212-70750

N1202 (10) N1203 (10)

Blood tank connector pelvis male (pkg 10) Blood tank connector pelvis female (pkg 10)

212-70850

N1045

DFS-2W Flow sensor unit

212-70950

N1066

DFS-2W(r) Rotor assembly

212-71150

N1105

Pressure regulator

212-71050

N1167

Pressure Regulator Secretions

Page 109 of 127

TSM Draft

Arms
Cat. no BOM Photo Description

Arm left top/bot. mated

21263050

N0634 N0635 N0819 (15)

Hand Left 21263150 N0636

Hand Right 21263250 N0631 N1050 (10) N1051 (10) Pulse Skin Small (radial pulse) Pulse Skin Large (brachial pulse)

Cable, Left Arm Pulses 21263550

N1004

Cable, BP_speaker 21263650 N1018 21263750 Cable, Left Convulsion adapter to IV-PCB

N0895

Page 110 of 127

TSM Draft

Convulsion Assy complete 21263850 S21252 N0629 N0630 N0657 (antenna wire) N0860 (4) FST 2007

Arm right, w/antenna wire and board

21263950

21264050

N0936

Cable, Right Arm Radial Pulse

N0655 (10) TBD

IV Filter house

21264250 21264350 21264450 21264550

FST2011

Drug and RFID subassembly

Cable, Power (Drug Reg. Board to Base Board) N0896 Cable, Left Convulsion to adapter N0894 N0658 Need photo Cable RF Ant. Select board to Jaw Ant. Board Sound reduce foam (flow meter) N0750

21264650

21264750 S21251 Included tubes!!! Need new photo

Flow meter Assy Complete w/tubes

Page 111 of 127

TSM Draft

Legs
Cat. no BOM Photo Description

21265050

Upper leg right, mated N1155

21265150

N0710 N0778 N0783 N0840 (2) N0780 N0800 N0681 N0799 Need photo

21265250

Drain block Drain valve N0783 Connecting tube N0840 T-connection N0780 Drain tube N0800 Compressor tube N0840 T-connection N0681 Knee module N0799 Pressure tube

21265750 21265850 TBD 21266050

N0708 Foot Right Core Need photo N1053 TBD S21271 Need photo Need photo Foot right skin Ankle joint complete Pressure tank Assy complete

21266150

N0669 N0670 N0962 (17pcs)

Lower leg right, mated

21266250 212-

FST 1012 N0783

Compressor Board Knee module Assy (from

Page 112 of 127

TSM Draft
65250 N0840 (2) N0780 N0800 N0681 N0799 Need photo compressor to leg)

21266650

N1122 N1124 N0801

Pulse cables (right pedal)

21266750

N1195 (10)

Pulse skin popliteal

21266850

S21273

Compressor Assy Complete

21266950

N1156

Upper leg left, mated

21267050

N0950 N0951 N0962 (17)

Lower leg left, mated

21267150

N1005

Cable, Left Pedal pulses

21267250 21267350 21267450

N1134 N1054
Need photo

Cable, Left Popliteal pulse Foot left skin

N0953

Need photo

Foot left core

Page 113 of 127

TSM Draft

Page 114 of 127

TSM Draft

ATTACHMENT IV Graphical User Interface GUI Auto Mode: running validated built in patient cases GUI in Auto Mode:
1 3 2 8

5 6

Screen sections include: 1. Program menu bar 2. Learner events 3. Instructors patient monitor 4. Patient status and Airway status 5. Technical status 6. Performance 7. Simulation control and session log 8. Common learner events

Page 115 of 127

TSM Draft

Instructor Mode: on-the-fly simulations or running your

preprogrammed scenarios.

GUI in Instructor Mode:

1 2 3

11

4 10 5 6 7

Screen sections include: 1. Program menu bar 2. Learner events 3. Instructors patient monitor/Cardiac controls 4. Eyes 5. Airway and breathing 6. Circulation & fluids 7. Sounds 8. Technical status 9. Performance 10.Simulation control and Session log 11.Common learner events

Page 116 of 127

TSM Draft

GUI in Classic View:

1 5 2

6 4

10

Screen sections include: 1. Program menu bar 2. Learner events 3. Instructors patient monitor/ Cardiac controls 4. Eyes 5. Airway and breathing 6. Circulation & fluids 7. Sounds 8. Technical status 9. Performance 10.Simulation Control and Session Log

Page 117 of 127

TSM Draft

ATTACHMENT VI Need review SimMan 3G TROUBLESHOOTING GUIDE

Page 118 of 127

TSM Draft

Breathing No chest rise Only unilateral chest rise Resistance will not change Check if manikin is in sleep mode due to recent inactivity, reactivate the manikin Check for leakage in chest rise bladders Check if tubes are disconnected from chest rise bladders Check if tubes are kinked Check if air from compressor, and check if the condensation relief valve is closed If recently used, compressor may be overheated and is cooling down, wait 20 minutes Restart manikin

- Valve could be clogged/broken - Leakage in chest rise bladder - Servo motor for lung assembly stuck - Lost communication with valve board (Reset valve board and see if it calibrates) Check for lung silicone string in the lung assembly intersects between the lung bladders folds Silicone tubing has been forced down causing conflict between hook and lung plate top. Lift silicone tubing up Lost communication with valve board (Reset valve board and see if it calibrates) If there is shallow chest movements and the internal compressor never stops running Compressor is worn, replace compressor Kinked tubing or leakage Check settings in GUI Page 119 of 127

Compliance will not change

Shallow chest movements

TSM Draft CO2 exhalation - If no CO2 present it might be the valve not working (in pelvis) - Kinked tubing - Empty CO2 tank?

No Oxygen saturation and waveform No Cyanosis Not possible to do chest tube insertion Broken cable in head (under face skin) LEDs loosen and fallen behind airway Problems with communication with head

Airway Complications No detection of Head position No Tongue edema - Kinked tubing - Check communication with head - Kinked tubing - Check communication with head - Leakage in bladder - Broken valve - Check communication with head - Kinked tubing - Check communication with head - Leakage in bladder - Kinked tubing - Check communication with head - Leakage in bladder - Kinked tubing - Check communication with head - Leakage in bladder - Kinked tubing - Check communication with head - Leakage in bladder

Tongue always with edema No Pharyngeal swelling

No Laryngospasm

No DCRM (Decreased cervical range of motion) No Trismus

Page 120 of 127

TSM Draft

Pulses Pulse does not work - Check if broken cable - Check circuit board - Carotid pulses: Baseboard - Femoral pulses: - Brachial: IV Board - Left Pedal Pulses: Baseboard - Right Pedal Pulse: Compressor board - Pulse unit might be stuck, change pulse unit - Pulse driver on baseboard - Broken cable Skin may be too tight over pulse units, readjust skin and restart manikin NOTE: These pulses are programmed to be weaker than central pulses like carotid and femoral pulses, and can be harder to detect/feel - Compressor board failure

Pulse is working, but palpation is not detected on Instructor PC Cannot feel pedal pulses

Debrief Viewer Web-camera doesnt record video capture for use in the debriefing Check that the web-cameras USB-cable is plugged into the Patient Monitor PC. Connect to the same USB connector every time Check the Profile Editors webcamera settings. Ensure that the settings match with how the webcamera is connected. Ensure that there are not other active USB cameras on the PC Ensure that the computer to which the web-camera is attached Page 121 of 127

TSM Draft is available when going to debrief Check that the name of the Patient Monitor PC being used corresponds with the settings in the profile in use

Patient Monitor video capture isnt included in the debriefing

WLAN Connection between the PCs and the manikin is frequently lost The WLAN might interference with other radio traffic or noise (e.g. Bluetooth, cell phones) Could try to change WLAN channel (ref. DFU). Also see the SUN site for more help in choosing the best channel Avoid solid material (especially metal) blocking the signals Windows Vista have features for power management, there are settings that controls the WLAN adapter. Please configure it for Maximum performance When the manikin is stationary, customer could consider using wired network between the manikin and PCs

The manikin works with LAN cable, but not with WLAN

If it is possible to connect the manikin on WLAN using another computer, the problem most likely relates to the actual computer - Check if WLAN is enabled on the computer 1. Check that any button on the computer that controls WLAN is set to enable or on 2. Check that WLAN is not disabled by the driver - Check that the adapter is set up with the correct TCPIP settings. Default is using DHCP (Obtain an IP address automatically) - The WLAN adapter drivers and utilities might be equipped with Page 122 of 127

TSM Draft features that allow intelligent control of the radio. These sometimes decide to shut down the adaptor for some reason. Typically this happens after the computer has been in sleep mode or similar. Disable such features. Consider removing OEM utilities all together and rather use Windows built-in features instead. If it discovers other WLAN networks, but not the manikin, start looking for problems in the manikin: - Check if the WLAN adapter inside the manikin is properly connected to the USB cable connector marked WLAN and not the auxiliary USB connector - Check the networks settings by attaching an empty USB memory stick to the auxiliary USB connector and remove it after 30 sec. An xml-file should be created on the memory stick. Open the file using text editor (Notepad etc) and check that networks settings are correct - As a last resort you may restore the manikin to fabric defaults. This could be done by attaching the external optical drive to the auxiliary USB connector and inserting the recovery DVD. Then start up the manikin. The recovery process will take a considerable time. Vocal feedback will be played through head speaker. Once recovery is finished you may have to update the SW using the Update Manikin feature.

Can not find the manikin

If the manikin is discovered on WLAN, but are not able to connect

The problem often is related to security keys - SimMan 3G uses WPA authentication by default. The Page 123 of 127

TSM Draft default password is SimMan 3G You might have a problem with a WLAN profile, please delete existing WLAN profiles associated with the manikin and try reconnecting Make sure that the SimMan 3G manikin and the PC are powered on From the PC, run cmd (Windowsbutton + R), type cmd and press enter Type ping-t 192.168.170.1 (with wireless connection) or 192.168.169.2 (with cable connection)

To check the connection between the manikin and the PCs

NOTE: The same numbers apply for all manikins You will get error messages if you are missing connection, retry or contact 3rd Line Support, R&D Laerdal.

RFID No RFID Tag is detected - Could be interrupted of metal, move manikin and try again - Lost communication with IV arm - Tag not working, try another tag - Problems with antenna select board Could be from a wrong batch, not programmed - Jaw antenna: Check if antenna wire is properly connected - Antenna in IV Arm: Check if properly soldered on circuit board - Check for moisture/water/corrosion in IV arm - Tune antennas Page 124 of 127

A certain RFID Tags is not detected RFID Tags are difficult to detect

TSM Draft

SOUNDS No Vocal Sound No Heart Sound No Lung Sound No Korotkoff Sound - Check cabling - Check cabling - Check cabling - Check cabling - Correct pressure applied?

Eyes Eyes always closed Pupils do not respond to light, when running Healthy Patient Check communication with head Check settings in GUI If eyelid is loose you will have to restart the headboard/manikin Check communication with head Check settings in GUI Shaft has loosened from cog wheel. Replace eye module Recalibrate or restart manikin/headboard Check settings in GUI Check communication with head Check settings in GUI Pupils are stuck, replace eye module

Eyes always open Strange sound from eye module Pupils not synchronized when running Healthy Patient

Eye not blinking properly

- Try to push in eyelid shaft - Check for friction between eyelid and skin

Secretions No secretions from Ears Check tubing from pelvis and for kink in head Check valve Page 125 of 127

TSM Draft No secretions from Nose Check restriction manifold in head (under face skin)

Check tubing from pelvis and for kink in head - Check valve - Check restriction manifold in head (under face skin) Check tubing from pelvis and for kink in head Check valve Check restriction manifold in head (under face skin) Check tubing from pelvis and for kink in head Check valve Check restriction manifold in head (under face skin) Particles in valve, flush in opposite direction

No secretions from Mouth

No secretions from Eyes

Can not turn off secretion

Blood/ Fluid /Secretions/ Urine Can not turn urine off Particles in valve, flush opposite direction

CPR Not detected on Instructor PC when doing CPR Check cabling Check for damage on compression sensor unit

IV Access Not possible to do injection Do not force injection! (could cause leakage inside arm) Try initialize and calibrate via Test Utility Page 126 of 127

TSM Draft IV-fluids and drugs are incorrectly measured Reset arm/manikin If still not working open arm and look for any damages in IV system/Flow meter Check if is possible to inject only through IV Catheter, if not replace IV Catheter If the problem is not the IV Catheter replace the Flow meter Clean the IV arm with distilled water and ethanol solutions (ref. DFU) Recalibrate the flow meter (on Instructor PC, go to ToolsMaintenance-Calibrate IV Flow meter)

ECG No ECG rhythm on Patient Monitor - Check cabling

Page 127 of 127