Service Manual
93 Pages
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Table of Contents
Table of Contents Contents Table of Contents ... 2 1 General...6 1.1 Standards Compliance ... 6
2 3
4
1.2
CE Mark ...6
1.3
Classification ... 6
1.4
Warnings ...7
1.5
Cautions ...8
1.6
System Installation ... 9
1.7
Multiple Portable Socket Outlets (Including Isolation Transformers) ... 10
1.8
Electromagnetic Compatibility ... 11
1.9
Service & Warranty ... 11
1.10
Addresses ... 11
1.11
UK... 11
Introduction ... 12 Product Description ... 13 3.1 SC1000: Standard Features ... 13 3.2
SC1000: Optional Features ... 13
3.3
Front Panel Controls & LED'S ... 14
3.4
Rear panel Connectors ... 15
3.5
I/O Sockets ... 16
3.6
ECG/SPO2 and Temperature Connections ... 17
3.7
NiBp Connector... 18
3.8
IBP Connector... 18
3.9
Capnography (CO2 ) Connector ... 18
3.10
Display and Controls... 19
Product Specification ... 20 4.1 Physical Specification ... 20 4.2
Environmental ... 20
4.3
AC Supply Voltage and Fuse Values ... 20
4.4
Battery Specification ... 20
4.5
ECG ... 21
4.6
SPO2 ... 22
4.7
Respiration ... 23
4.8
Temperature ... 24
4.9
Non Invasive Blood Pressure NiBp ... 24
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Table of Contents
5
6
7
4.10
Invasive Blood Pressure IBP ... 25
4.11
Capnography CO2 ... 25
4.12
Recorder ... 26
Safety Testing ... 27 5.1 Electrical Safety Test: Protective Earth ... 27 5.2
Electrical Safety Test: Enclosure leakage current ... 28
5.3
Electrical Safety Test: Patient Connections leakage current ... 28
5.4
Earth Leakage... 29
5.5
Enclosure Leakage Current ... 30
5.6
Patient Leakage Current ... 31
5.7
Patient Auxiliary Current – (Mains Voltage on the Applied Part) ... 34
Performance Verification ... 35 6.1 Equipment Needed ... 35 6.2
Performance Tests: Power ... 35
6.3
Performance Tests: Display and Touchscreen ... 36
6.4
Performance Tests: Patient Information ... 36
6.5
Performance Tests: Language ... 36
6.6
Performance Tests: Time and Date ... 36
6.7
Performance test: Alarm Suspend Settings ... 36
6.8
Performance Tests: Setup Menu Slider Controls ... 37
6.9
Demo Mode ... 37
6.10
Recorder (If Fitted)... 37
6.11
Performance Tests: Trace Speed ... 37
6.12
Performance Tests: Trends ... 37
6.13
Performance Tests: Freeze Screen ... 38
6.14
Performance Tests: Disable touchscreen ... 38
6.15
Performance Tests: ECG... 39
6.16
Performance Test:-Respiration ... 41
6.17
Performance Tests: SO2 ... 42
6.18
Performance Tests: Temperature ... 42
6.19
Performance Test: NiBp (If Fitted) ... 43
6.20
Performance Test: IBP (If Fitted) ... 45
6.21
Performance Tests: CO2 (If Fitted) ... 46
6.22
Empty Module Slot Test... 49
Diagram ... 51 7.1 Figure 1 ... 52 7.2
Figure 2 ... 53
7.3
Figure 3 ... 54
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Table of Contents
8
9
7.4
Figure 4 ... 55
7.5
Figure 5 ... 56
7.6
Figure 6 ... 57
7.7
Figure 7 ... 57
7.8
Figure 8 ... 58
7.9
Figure 9 ... 59
7.10
Figure 10 ... 60
Assembly Breakdown ... 61 8.1 Tools Required... 61 8.2
Battery ... 62
8.3
Rear Case ... 64
8.4
Recorder ... 66
8.5
Mains PSU ... 67
8.6
LV PSU ... 68
8.7
Processor ... 69
8.8
Main Electronic Assembly ... 71
8.9
TFTTouchscreen... 71
8.10
Module Interface Board ... 73
8.11
Motherboard ... 75
8.1
SPO2 ... 76
8.2
Respiration ... 77
8.3
ECGDual Temperature ... 78
8.4
NiBp ... 79
8.5
Invasive Blood Pressure ... 80
8.6
CO2 ... 81
Calibration ... 82 9.1 Battery gauge conditioning ... 82 9.2
Reset Factory Defaults ... 82
9.3
NiBp Calibration ... 82
9.5
ECG ... 83
9.6
Temp ... 83
9.7
SPO2 ... 83
9.8
IBP ... 83
9.9
CO2 ... 84
10 Error Messages ... 85 10.1 ECG ... 85 10.2
Temp ... 85
10.3
SPO2 ... 85
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Table of Contents 10.4
NiBp ... 85
10.5
IBP ... 86
10.6
CO2 ... 86
11 Maintenance Schedules ... 87 11.1 Annual Checks ... 87 11.2
Real Time Clock Battery Replacement ... 87
12 External connection ... 88 12.1 LAN Connector ... 88 12.2
Serial Interface ... 88
12.3
VGA Out ... 88
12.4
Equipotential earth. ... 88
12.5
PS2 port... 88
13 Spare Parts ... 89 14 Trouble Shooting ... 91 Periodic inspection and preventative maintenance are essential to ensure continued effective operation. Contact the Company or its approved agents or distributors for further information on service contracts.
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General
1 General 1.1 Standards Compliance IEC60601-1 2nd Edition
1.2 CE Mark This equipment carries a CE mark but this is only fully valid if it is used in conjunction with cables and accessories approved by Huntleigh Healthcare Ltd.
Denotes conformity with the European Council Directive 93/42/EEC concerning medical devices
1.3 Classification Shock Protection Class -
Class 1 mains powered equipment
Shock Protection – Degree
Type CF with defibrillator protection
Water Ingress Protection
Ordinary Equipment (IPX1)
Flammable Gasses
Not suitable for use in the presence of flammable gasses
Operation Mode
Continuous
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General
1.4 Warnings
Warnings are identified by the WARNING symbol show. Warnings alert users and technical personnel to the potential; serious outcome (death, Injury or adverse events) to the patient or user
Do not touch live parts of any equipment (e.g. comport connector pins on a pc) and the patient at the same time. Explosion hazard. Do not use the smartsigns Compact 1000 (SC1000) in the presence of flammable anaesthetics or gasses.
Do not spray, spill or immerse the SC1000, its connector’s switches or openings in the chassis.
Electrical shock hazard Disconnect the power cord from the SC1000 before attempting to disassemble the SC1000 The use of accessories, transducers and cables other than those specified may result in increased emissions and or decreased immunity of the SC1000 patient monitor Do not silence SC1000 audible alarm or decrease its volume if patient safety could be compromised During safety tests, AC mains voltage will be present on the applied part terminals. Exercise caution to avoid electrical shock hazard. Do not place SC1000 into operation after repair or maintenance until Performance and Safety Tests listed in this service manual have been performed. This product contains sensitive electronics; strong radio frequency fields could interfere with the operation of the system. In the event where this occurs, we suggest that the source of interference is identified and the equipment is used 'out of range'. Do not use high temperature Sterilising of E-beam / gamma sterilisation processes.
Do not use solvent cleaner on any part of the system.
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General
1.5 Cautions
Cautions are identified by the Caution symbol shown. Cautions alert users and technical personnel to exercise care necessary for the safe and effective use of the SC1000 Patient monitor. Do not operate the equipment using damaged cables and wires, or loose snap fittings, which may cause interference or loss of signal. A frequent electrical and visual inspection on cables and wires is advisable. Observe ESD (electrostatic discharge) precautions when working within the unit and/or when disassembling and reassembling the SC1000 monitor and when handling any of the components of SC1000 patient monitor. Ferrite Cores are used for electromagnetic compatibility. Do not remove Ferrite Cores while disassembling or reassembling. For continued protection against risk of fire, replace only with same type and rating of fuse.
The accuracy of the readings obtained from this equipment may be affected by the presence of a pacemaker or by cardiac arrhythmia. The accuracy of the readings obtained from this equipment may be affected by the presence of a pacemaker or by cardiac arrhythmia.
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General
1.6 System Installation These requirements must be met when an SC1000 is connected to any of the following pieces of equipment:
CentralView, Central nurse station
A Pc Non-medical equipment must comply with the relevant IEC or ISO safety standards, for Information Technology equipment, this standard is IEC950/ EN60950 Medical equipment must comply with IEC601-1/EN60601-1 or equivalent. The configured system must comply with the system standard IEC601-11/EN60601-1-1 If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those permitted by IEC601-1/EN60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage current must be bought within the limits permitted by IEC601-1/EN60601-1, this may be achieved with the use of an isolating transformer, suitable types are available via Huntleigh Healthcare sales agents. Anybody who connects additional equipment to the signal input or signal output parts of the system is configuring a medical system and is therefore responsible for ensuring that the system complies with IEC601-1/EN60601-1-1. If there is any doubt as to whether your system does comply , consult with a the technical service department of your local Huntleigh Healthcare Ltd. The connection of extra equipment to the patient of SC1000 patient monitor could lead to the summation of leakage currents. In such cases the user must ensure that safe leakage currents are not exceeded
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General
1.7 Multiple Portable Socket Outlets (Including Isolation Transformers) Note: an Isolation transformer is a particular kind of multiple socket outlets. It is not recommended to power a medical system from a multiple portable socket outlet which is not supplied form an isolating transformer (IEC601-1-1/EN60601-1-1 Amendment 1). If such an outlet is in use, it should comply with the requirements of Annex EEE.2 of IEC601-11/EN60601 Amendment 1). If such an outlet is in use, it should comply with the requirements of Annex EEE.2 of IEC601-1-1/EN60601-1-1 Amendment 1. Do not exceed the power rating for the multiple portable sockets Do not place multiple portable socket-outlets on the floor. This is to protect against mechanical damage and the ingress of liquids. Multiple portable socket-outlets supplied with the system must not be used for powering equipment which does not form part of the system; This is to prevent the increased leakage currents and overload of the multiple portable socket outlets. If the system has been specified for use with Isolation transformer do not connect any non-medical electrical equipment which forms part of the system directly to the wall outlet, this is to prevent excessive leakage currents. Anybody who connects additional equipment to the signal input or signal output parts of the system is configuring a medical system and is therefore responsible for ensuring that the system complies with IEC601-1-1. If there is any doubt as to whether your system does comply consult the technical service department of your local Huntleigh Healthcare Ltd.
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General
1.8 Electromagnetic Compatibility
Make sure the environment in which the SC1000 is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones).
This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer's instructions, it may cause or be subject to interference. Type-tested in a fully configured system, it has been found to comply with IEC601-1-2/EN60601-1-2, the standard intended to provide reasonable protection against such interference. Whether the equipment causes interference may be determined by turning the equipment off and on. If it does cause or is affected by interference, one or more of the following measures may correct the interference: Reorientation the equipment Relocating the equipment with respect to the source of interference Moving the equipment away from the device with which it is interfering Plugging the equipment into a different outlet so that the devices are on different branch circuits Adding accessories or components to a system, or modifying a medical device or system, may degrade the immunity performance. Consult qualified personnel before making changes to the system configuration.
1.9 Service & Warranty Huntleigh Healthcare's standard terms and conditions apply to all sales. These contain full details of warranty terms and do not limit the statutory rights of the consumer. A copy is available on request. If there is any reason to return the SC1000 unit, please: 1. Clean the product, as described in the cleaning section. 2. Pack it in suitable packing. 3. Attach the decontamination certificate (or other written statement declaring that the product has been cleaned) to the outside of the package (Our service department reserve the right to reject items that appear to be contaminated). 4. Mark the package "Service Department – SC1000” and return to the address below.
1.10 Addresses 1.11 UK Huntleigh Healthcare Ltd 35 Portmanmoor Road, Cardiff. CF24 5HN. UK. Tel: +44 (0) 2920 485885 Fax: +44 (0) 2920 492520 E-mail: [email protected]
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Introduction Web page: www.huntleigh-diagnostics.com
2 Introduction
This manual contains information servicing the SC1000 patient monitor and its modules. Only qualified service personnel should service this product. Before servicing the SC1000 read the products instructions for use carefully for a thorough understanding of safe operation. Read and understand all safety warnings and service notes printed in this service manual and the user’s manual. The fault finding described is only intended to identify boards, modules or major components that need to be replaced, this document is not intended as a full diagnostics tool because many of the boards and modules cannot be satisfactorily repaired in the field and must be returned to Huntleigh Healthcare if faulty. If any warranty claim is intended then it is important to ensure that any security seals are intact on the items to be returned if the warranty is not to be invalidated. To reduce the risk of electric shock, do not remove the rear enclosure, Refer servicing to qualified service personnel. Only trained service technicians should perform all unit repairs. To isolate the SC1000 from the mains or supply line, disconnect the power cable from the mains inlet at the rear of the unit. Voltages dangerous to life exist in this unit, Take care when servicing the power supply and front panel assembly.
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Product Description
3 Product Description The smartsigns® compact 1000 is a modular multi parameter vital signs monitor, providing the user with high specification, reliable monitoring solution. Originally designed to satisfy the increase in day surgery and outpatient procedures the smartsigns® compact 1000 can be used in a variety of mainstream clinical environments. The smartsigns® compact series has been developed using a combination of high specification modular technologies , selecting from five monitoring options, the modular concept enables the user to tailor the configurations to match their exact requirements.
3.1 SC1000: Standard Features The following features are standard for all SC1000 configurations.
10.4” high resolution screen.
ECG/SPO2 and Temperature as standard.
Alarms
Ethernet connector for connection to the CentralView system
Serial and PS2 ports for connection to a computer and keyboard for updating.
Fully configurable alarms and settings using the ConfigManager software
Modular system allowing any combination of ECG/Temp/Resp, SPO2, Non-invasive blood pressure, Invasive blood pressure or Capnography to be selected.
Internal Battery, providing approximately 2.5 hours of battery back-up power
Intuitive graphical user interface.
External VGA connector
Up to 7 days of trend data maintained(unit must remain on to maintain trends)
3.2 SC1000: Optional Features In addition to the above, the following features are available as optional extras
Thermal recorder
Non Invasive Blood Pressure
Invasive Blood Pressure
Capnography
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Product Description
3.3 Front Panel Controls & LED'S
1
2
4
3
To isolate the SC1000 from the mains or supply line, disconnect the power cable from the mains inlet at the rear of the unit.
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Product Description
3.4 Rear panel Connectors 5 1
6
2
7
3 4
Key
Description
1
Carry Handle
2
Stand fixing (old version)
3
Module Release Mechanism
4
Battery
5
I/O Sockets:-
6
50mm high speed thermal printer(factory fit option)
7
Mains input socket and Line/Neutral Fuses
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Product Description
3.5 I/O Sockets Symbol
Description Network
Serial Port
Keyboard
External Monitor
Equipotential earth point
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Product Description
3.6 ECG/SPO2 and Temperature Connections
ECG
3/5 Lead ECG patient cable input socket
T1
Temperature Probe 1
T2
Temperature Probe 2
SpO2
BCI Pulse Oximetry finger probe connector (extension cable must be used) This symbol indicates type CF applied part with defibrillator protection. WARNING : Safety and performance are only assured when used in conjunction with the correct type of extension cable/patient cables and sensors, Do not attempt to connect cables and sensors to this device other than those that have been supplied by Huntleigh Healthcare
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Product Description
3.7 NiBp Connector
NIBP
Nibp hose connector for the connection of Adult, Paediatric or Neonatal Nibp cuffs
3.8 IBP Connector
IBP1
ART Invasive blood pressure transducer connector
IBP2
CVP Invasive blood pressure transducer connector This symbol indicates type CF applied part with defibrillator protection. WARNING : Safety and performance are only assured when used in conjunction with the correct type of transduce and extension cable, Do not attempt to connect Transducers or cables to this device other than those that have been supplied by Huntleigh Healthcare
3.9 Capnography (CO2 ) Connector
Exhaust gasses from side streaming CO2
Side-stream sensor port
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Product Description
3.10 Display and Controls
The SC1000 has a 10.4” TFT-LCD module with a built in white LED Backlight, 800 x 600 SVGA resolutions and displays 262k/16.2M colours. Horizontal Viewing angle typically 160˚ Vertical Viewing angle typically 140˚ Navigation of the graphical user interface is achieved via the 4 wire resistive touchscreen; the functions and features of the graphical user interface are detailed in the user manual.
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Product Specification
4 Product Specification 4.1 Physical Specification Height
240mm
Length
140mm
Width
310mm Weight
Basic Chassis
3.5kg
Chassis with recorder and fixing plate
3.9kg
ECG
0.28kg
NIBP
0.33Kg
CO2
0.25Kg
IBP
0.19Kg
Blank Module
0.14Kg
4.2 Environmental Operating
Storage
10˚C - 40˚C
Temperature
-10˚C to + 50˚C
30% - 90% ( non-condensing)
Relative Humidity
0% - 99% (non-condensing)
860mb – 1060mb
Pressure
860mb – 1060mb
4.3 AC Supply Voltage and Fuse Values Rated AC supply voltage
100=120V, 220-240V, 50-60Hz
Fuse Values
2A T HBC 250V 0001.2707
Power Rating
120VA
4.4 Battery Specification Battery
10 Cell, NiMh 3.8Ah
Temperature Sensor
25KΩ @ 20˚C
Thermal Cut out
Self-Resetting 70 ˚C
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