SimMan 3G Technical Service Manual Rev B

Technical Service Manual

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SimMan 3G Technical Service Manual

Att 1 to PRO-PR01-2933 Rev B01

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 Lung Module 3.3.1.1 Compliance 3.3.1.2 Restriction 3.4 CO2 System 3.5 Bleeding & Fluid System 3.5.1 Bleeding System Pelvis 3.5.2 Fluid distribution Unit Pelvis 4.0 Functional Verification 4.1 Battery Operation 4.2 Battery change 4.3 Battery – Heat warning 4.4 Battery Capacity and power down of manikin 4.5 How to access the Test Utility Program 4.6 Test Utility Program 4.6.1 Head 4.6.2 Arm 4.6.3 Valve 4.6.4 Leg 4.6.5 Vital Signs 4.6.6 Sounds 4.6.7 Comp/Vent 4.6.8 Pulses 4.6.9 Status 4.6.10 Power 4.6.11 Defib/Pacing 4.6.12 Test 4.6.13 Update 4.7 Manikin statistics 5.0 Interconnection System 5.1 Cable Connections between the circuit boards 5.2 Base Board cable connections 5.3 Head Board cable connection 5.4 Valve Board & Lung Boards cable connections 5.5 Drug registration Board cable connections 5.6 Compressor Board cable connections 5.7 Tubing in Head, air distribution 5.8 Tubing in Head, Fluid distribution 5.9 Tubing in Neck, Air distribution 5.10 Tubing in Neck, Fluid distribution

4 4 5 5 6 7 12 12 13 14 15 16 18 18 20 22 23 24 25 26 27 28 29 29 29 29 29 30 31 31 33 34 35 36 37 38 39 40 41 42 43 44 45 46 46 47 48 49 50 51 52 53 54 55

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6.0

7.0

5.11 Tubing in Torso, Air and Fluid 5.12 Tubing in Pelvis, Air distribution unit Assy 5.13 Tubing in Pelvis, Fluid distribution unit Assy 5.14 Tubing in Pelvis, Fluid fill panel Assy 5.15 Tubing in Pelvis, Valve Board 5.16 Tubing in Pelvis, Manifold Assy 5.17 Tubing in Pelvis, Blood valves and pressure regulator Assy 5.18 Tubing in Pelvis, Chest rise valves Assy 5.19 Tubing in Pelvis, Fluid Pressure regulator Assy Exploded views 6.1 Head Assembly 6.2 Skull Lower Assembly 6.3 Neck Assembly 6.4 Torso Assembly 6.5 Torso w/Pelvis Assembly 6.6 Torso (back) Assembly 6.7 Torso (front) Assembly 6.8 Torso Base plate Assembly I 6.9 Torso Base plate Assembly II 6.10 Torso Base plate w/ Base Board Assembly 6.11 Back Cover Assembly, w/speakers 6.12 Chest Assembly I 6.13 Chest Assembly II 6.14 Valve Board Protection Assembly 6.15 Fluid Panel 6.16 Pelvis Mechanical Assembly 6.17 Leg Left Assembly 6.18 Leg Right Assembly 6.19 Pressure Tank 6.20 Lower Right Leg 6.21 Compressor 6.22 Left Arm, BP Arm 6.23 Right Arm, IV Arm 6.24 Flow meter Assembly (right arm) 6.25 IV Arm w/antenna Networking and Communication System 7.1 Networking Overview 7.2 Communication System

56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 91 92

ATTACHMENT I ATTACHMENT II ATTACHMENT III

93 107 110

Service Parts – SimMan 3G Graphical User Interface - GUI SimMan 3G Troubleshooting Guide

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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 its associated peripherals as well as information on the mechanical assembly of the manikin. Please note that the Directions for Use manual provided with every new manikin should be consulted for detailed information on use of the product.

Note To be able to read schematics and drawings in detail, this manual includes some pages in which need to be printed in A3 format.

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

Note

Servicing of the SimMan 3G simulator should only be performed by authorized service personnel. Servicing by others may invalidate the warranty of the product. Copyright © 2001-2011 Laerdal Medical. All rights reserved. The content of this document/work, including, without limitation, text, images and graphics are the copyrighted works of Laerdal Medical. Reproduction in whole or in part, whether on paper, on internet, on CD-ROM, or any other medium, including utilization in machines capable of reproduction or without the express permissions of Laerdal Medical is prohibited.

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.

•

Defibrillation of manikin with open torso skin or open back cover should not be performed.

•

Do not open the air compressor with compressed air in the tank; always drain the compressed air before service.

•

The tank drain valve (located on the right upper leg) has to be open when filling the reservoir with fluid or simulated blood.

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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 doesn’t require physical connections to any hardware.

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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**: • 5°C : 4h 20 min • Room temperature: 4h 15 min • 40° : 3h 10 min o Battery capacity Worst case Patient***: • 5°C: 3h 35 min • 40°C: 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 motion 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 and 5.0 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: +4°C - + 40°C (39°F to 104°F) o Storage*: -15°C - + 50°C (5°F to 122°F) *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

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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 with 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

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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

RF Electromagnetic Fields

80-2000 MHz

SimMan 3G may sometimes be susceptible to interference from other RF communication equipment. In such instances increase the distance between the SimMan 3G and the interfering RF transmitters.

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

Electrostatic Discharge

4kV contact* 8kV Air

Observe precautions for handling of electrostatic sensitive devices during service and maintenance of the manikin.

* 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

Conducted emission

0.15 MHz – 1GHz

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 to nearby electronics equipment.*

EN 301 489-1 Test Method: EN 55022

Radiated emission

Equipment class B Harmonic Current Emission

Test method and limits: EN 61000-3-2

Voltage Fluctuation and Flicker

Test method and limits: EN 61000-3-3

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Att 1 to PRO-PR01-2933 Rev B01 * 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

Operating Range [meter]

Power [Watt] RFID

13.56 MHz

< 0.2 m

WLAN

2.412 ~ 2.462 GHz

13 dBm – 18 dBm

< 100 m

(Channels 1-11) 5.180 – 5.320 GHz (Channels 36,40,44,48-64) 5.745 – 5.825 GHz (Channels 149-165) 802.11 a/b/g/n Technical Specifications

RADIATION TEST

COMPLIANCE LEVEL

RADIO FREQUENCY COMMUNICATION ENVIRONMENT GUIDANCE

RFID

42 dBuA/m @ 10 m

GENERAL

Transmitter class 1

13.553 to 13.567 MHz

Receiver class 3

Duty cycle: Up to 100%

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

Antenna type 1 WLAN

20 dBm @ 3m

2,4 GHz

2.400 ~ 2.484 GHz

5,0 GHz

5.180 ~ 5.825 GHz

WLAN This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.

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Att 1 to PRO-PR01-2933 Rev B01 Applicable Regulations: • EU Directive, 1999/5/EC, Radio and Telecommunications Terminal Equipment (RTT&E) • 47 CFR Part 15 – Radio Frequency Devices (FCC) • FCC Part 15 – Radio Frequency Devices (FCC)

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. Manufacturer’s Declaration of Conformity is included in SimMan 3G Directions for Use. WLAN adapter is declared by manufacturer Gigabyte (2.4 GHz) and Engenius (5.0 GHz) to be in compliance with RTT&E Directive and CE marked as an individual component. Gigabyte was used as default in manikin from start of production until serial number 212-41101434 then Gigabyte was replaced with Engenius as default. Some of the products produced before serial number 212-41101434 might have been upgraded to Engenius adapter. 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 WLAN - SPECIAL CONSIDERATIONS SimMan 3G will carry Class 2 Equipment identifier for WLAN. Restrictions on use in 2.4 GHz band: France: Outdoor use not allowed in France. Open channels in 5 GHz band: Channels 36, 40, 44, 48, 52, 56, 60, 64 are open across Europe

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 micro volts/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, either for Gigabyte or Engenius (ref. 1.3.4.1). Contains FCC ID:

JCK-GN-WB31N-RH Gigabyte U2M-UB9801MOD Engenius

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Att 1 to PRO-PR01-2933 Rev B01 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. (2) This device must accept any interference received, including interference that may cause undesired operation. 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.

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TOUR OF THE SIMULATOR 2.1. External Connections and Vascular Access

Defibrillation Connections Sternal IO Module

BP Cuff

IV Catheter

Refill Unit Blood Compressor /Regulator /CO2 bottle

LAN (Ethernet) Power Supply

Refill Unit Fluid Intra Muscular Injection (IM Pad)

: ECG Connections (4) : IM Pad (right buttock)

Tibial IO Module

Fig. 1

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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

Blood port Urinary port (internal)

Fig. 2

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2.3. Overview Pulses

Carotid Pulse (Right)

Carotid Pulse (Left)

Brachial Pulse (Left) Radial Pulse (Right)

Radial Pulse (Left)

Femoral Pulse (Right)

Femoral Pulse (Left)

Dorsalis Pedis (Right)

Dorsalis Pedis (Left)

Posterior Tibial Pulse (Right)

Posterior Tibial Pulse (Left) Fig. 3

Popliteal Pulse (Right) Popliteal Pulse (Left)

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2.4. Internal System Overview Head Board

Head Manifold

Eye Modules

Jaw Antenna

Compression module Lung modules Drug and RFID Sub assembly

Base Board

- RFID Board - RFID Reader Module - Drug. Reg Board

System on Module (SOM) PC Card

IV Arm Antenna

WLAN Dongle

Antenna select board

Convulsion motor

Fluid Manifold M

Air distr. unit

Convulsion motor

Valve Board

Pressure Tank w/Blood and Fluid Bags

Batteries

Compressor M

Compressor Board

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2.5. Speaker and Sound System Overview All four heart speakers have their own channel, which means that sound and volume can be set for each speaker. Figure 6 illustrates locations of the Heart speakers:

1. RUSB – Right Upper Sternum (Aortic) (16 Ώ) 2. LUSB – Left Upper Sternum (Pulmonary) (16 Ώ) 3. LLSB – Left Lower Sternum (Tricuspid) (16 Ώ) 4. Apex – Mitral (16 Ώ) 5. BP (Blood Pressure) (8 Ώ)

3 3

Fig. 6

For the Stomach speakers there is one channel for all, and each speaker is 16 Ώ. Figure 7 illustrates the four Stomach speaker’s locations:

Fig. 7

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The microphones in the ears are parallel coupled (on head board) in head. Figure 8 illustrates the two microphones located in the ears, and the vocal speaker in the head. Vocal speaker (8Ώ) Microphone (2) Fig. 8

The five lung speakers in front have their own channel, which means that sound and volume can be set for each speaker. Torso Anterior (front) is illustrated with lung speakers in Figure 9:

1. RU 2. LU 3. RM 4. RLL 5. LLL

2 3

– Right Upper Lobe (16 Ώ) – Left Upper Lobe (16 Ώ) – Right Middle (16 Ώ) – Right Lower Lobe (16 Ώ) – Left Lower Lobe (16 Ώ)

Fig. 9

Torso Posterior (back) is illustrated with lung speakers in Figure 10: 6 7. 8. 9. 10. 11.

Fig. 10

LU RU LM RM LL RL

– Left Upper Lobe (16 Ώ) – Right Upper Lobe (16 Ώ) – Left Lower Lobe (16 Ώ) – Right Lower Lobe (16 Ώ) – Left Lower Lobe (16 Ώ) - Right Lower Lobe (16 Ώ)

LM & LL are parallel coupled (on Base Board), and share one channel. RM & RL are parallel coupled (on Base Board), and share one channel. LU and RU have both separate channels.

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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) Pneumothorax 5) Chest drain (left and right) 6) ECG 7) Lung Compliance 8) Lung Resistance 9) Ventilation 10) 11 x Lung Speakers 11) 4x Heart Speaker 12) System on Module (SOM) PCcard

PELVIS 1) USB WLAN dongle 2) Defib Apex 3) 4x Bowel sound 4) Fluid Manifold 5) Pneumatics Manifold 6) Valveboard PCB 7) 2x Femoral pulse 8) IM Pad

RIGHT LEG 1) ECG Right Leg 2) Blood & Fluid Bags 3) Popliteal pulse 4) Pressure Tank 5) Leg PCB 6) Compressor/pump

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

RIGHT FOOT 1) Pedal pulses

LEFT FOOT 1) Pedal pulses

Fig. 11

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HEAD 1)

2x Eye module: Active eyes w/lids pupils responding to light 2) Head speaker 3) Head control card 4) Head manifold 5) Jaw Antenna Board 6) 1 x Antenna for airway event registration 7) Tongue edema 8) Trismus 9) Pharyngeal swelling 10) Laryngospasm

NECK 1) 2) 3)

RIGHT ARM 1) 4x Antennas for Drug registration 2) IV module PCB 3) IV drain 4) Flowmeter 5) Right Radial pulse 6) Convulsion Right Arm

2x Carotid pulse Neck potentiometer, for registration of neck position/head tilt DCRM

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

Fig. 12

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

Fig. 13

Fig. 14 On the depth gauge there is a label placed 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 optical switch reads the pattern and then calculates the depth of compression.

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SimMan 3G Technical Service Manual Rev B