Technical Service Manual
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Graseby Instruction Manuals This publication has been compiled and approved by Graseby Medical Ltd for use with their respective products. It is supplied in this format to permit users to access the text and illustrations for their own use e.g. training and educational purposes. Users of the equipment must ensure that they have read and understood the contents of the complete manual including the warnings and cautions and have been trained in the correct use of the product. Graseby Medical Ltd cannot be held responsible for the accuracy and any resulting incident arising from information that has been extracted from this manual and compiled into the users documentation. These manuals are subject to revision and it is the users responsibility to ensure that the correct version of manual/ text/illustration is used in conjunction with the equipment.
Graseby MR10 Neonatal Respiration Monitor
Te c h n i c a l S e r v i c e Manual 0473
MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
Warnings Warnings tell you about dangerous conditions, that could lead to death or serious injury to the user or infant, that can occur if you do not obey all of the instructions in this manual. 1. 2. 3. 4. 5.
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7. 8.
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WARNING: The MR10 only informs of an apnoea attack, it cannot prevent an apnoea attack. WARNING: If you suspect that the Monitor is not operating correctly, do not use and return to SIMS Graseby or a suitably qualified technician for testing. WARNING: Only use the SIMS Graseby Respiration Sensor, REF 0108-0007. The performance of the Monitor can only be guaranteed with this Sensor. WARNING: The Respiration Sensor should only be used on one infant. Using the same Sensor on more than one infant increases the risk of cross infection. WARNING: Correct positioning of the Respiration Sensor tubing is important to avoid the tube becoming entangled around the infant’s neck, resulting in infant injury or death. WARNING: Mobile communication devices e.g. mobile phones, should not be used at a distance of less than one metre to the MR10 Monitor, as this could affect the safe operation of the Monitor. Even if these devices cause no obvious interference, possible interference can only be ruled out if this advice is strictly observed. WARNING: The Monitor is not suitable for use with adults or children over the age of 18 months. WARNING: The Monitor must not be covered by bedding or other objects so that the audible and visual alarms are impaired. Failure to observe this warning could result in infant injury or death. WARNING: To prevent the Monitor being accidentally switched off, the Monitor must not be placed within reach of the infant. Failure to observe this warning could result in infant injury or death. WARNING: The Monitor must not be pushed into confined spaces, so that pressure could be exerted upon the keypad buttons causing the Monitor to be switched off or the settings to be changed. Failure to observe this warning could result in infant injury or death. WARNING: If the Monitor alarms, before doing anything else make sure that the infant is safe and comfortable and not in a dangerous situation. WARNING: Use only type LR6 alkaline batteries. Rechargeable batteries are unsuitable and must not be used as they could affect safe operation of the Monitor. WARNING: This equipment is not suitable for use in the presence of flammable anaesthetics oxygen-enriched or explosive atmospheres. The use of the device in such atmospheres can lead to explosion or fire. WARNING: The Monitor must be operated within the specified parameters, see Technical specification page 1-11. Failure to do so could result in infant injury or death. WARNING: With the monitor working correctly, if an alarm occurs frequently then medical advice must be sought to ensure that the infant’s health is not in any danger. WARNING: The monitor must not be used in the presence of, or in combination with Magnetic Resonance Imaging (MRI) machines. Induced current could cause burns to the infant or user injury and affect the functions of the monitor. The monitor may also affect the MRI image. WARNING: To avoid possible malfunction of the monitor, do not expose the monitor to X-rays, gamma rays, ionising radiation, strong electric or magnetic fields such as diathermy or mobile telephones. Malfunction of the monitor can cause incorrect monitoring or loss of monitoring resulting in infant injury or death.
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MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
Cautions Cautions tell you about dangerous conditions that can occur and cause damage to the Monitor if you do not obey all of the instructions in this manual. 1. 2.
3.
CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the Monitor must not be carried out. CAUTION: Failure to observe the following cautions may cause internal damage to the monitor. • Do not autoclave, steam sterilise, pressure sterilise or gas sterilise this monitor. • Do not expose this monitor to temperatures in excess of 40°C (104° F). • Cleaning Do not immerse the monitor in any liquid. • Wipe off any liquid spills immediately, do not allow any fluid or residues to remain on the monitor. • Do not use abrasive agents or strong organic solvents. CAUTION: The Printed Circuit Board (PCB) contained in the monitor is electrostatically sensitive. Always use an earthing strap when handling the PCB to avoid electrostatic damage to the components. Ensure that replacement PCB are stored in anti-static containers.
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MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
Published by SIMS Graseby Limited. All possible care has been taken in the preparation of this publication, but SIMS Graseby Limited accepts no liability for any inaccuracies that may be found. SIMS Graseby reserves the right to make changes without notice both to this publication and to the product which it describes. ©
SIMS Graseby Limited 2001
No part of this publication may be reproduced, transmitted, transcribed, or stored in a retrieval system or translated into any human or computer language in any form by any means without the prior permission of SIMS Graseby Limited. SIMS GRASEBY LTD, Colonial Way, Watford, Hertfordshire, UK WD24 4LG TEL:
(+44) (0)1923 246434
FAX:
(+44) (0)1923 231595
WEB:
www.graseby.co.uk
REGISTERED IN ENGLAND COMPANY No. 995550
Trademarks and acknowledgements: Graseby; and SIMS are all trademarks of Smiths Industries Medical Systems. All other trademarks are acknowledged as the property of their respective owners.
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MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
ISSUE RECORD Issue No. A
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Reason for change
Pages effected
Date
Initial issue
All
April 2001
Issue A (April 2001)
M R 1 0 Te c h n i c a l S e r v i c e M a n u a l
MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
Contents Chapter 1 Introduction ... 1 - 1 Case design ... 1 - 1 Specification ... 1 - 3 Dimensions: ... 1 - 3 Weight: ... 1 - 3 Indicators ... 1 - 3 Sensitivity: ... 1 - 3 Timing accuracy: ... 1 - 3 Signal detection and filtering: ... 1 - 3 Batteries:... 1 - 4 Low battery indicator ... 1 - 4 External sensor: ... 1 - 4 Environmental conditions: ... 1 - 4 Alarm: ... 1 - 4 Materials used ... 1 - 4 Operating position: ... 1 - 4 Standards ... 1 - 5 Electrical Safety ... 1 - 5 EMC ... 1 - 5 Design Standards ... 1 - 5 Fluid Ingress Protection ... 1 - 5 CE Marking ... 1 - 5 Disposal ... 1 - 5
Chapter 2 Introduction ... 2 - 1 Circuit Description ... 2 - 2 Master Clock ... 2 - 2 Transducer oscillator ... 2 - 2 Alarm circuit ... 2 - 2 Visual indicators ... 2 - 2 Battery protection ... 2 - 2 Sensitivity adjustment ... 2 - 2
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Chapter 3 Acceptance and Routine Tests ... 3 - 1
Chapter 4 Cleaning and Maintenance ... 4 - 1 Cleaning... 4 - 1 Maintenance ... 4 - 1
Battery replacement... 4 - 2 Alarm system test ... 4 - 2 Disassembly of the monitor ... 4 - 3 Handling precautions ... 4 - 3 Replacing the transducer ... 4 - 3 Sensitivity setting ... 4 - 4 Replacing the front panel keypad membrane ... 4 - 4
Chapter 5 Illustrated Parts List ... 5 - 1 General assembly of the MR10 new case design (serial numbers from 80,000) ... 5 - 2 General assembly of the MR10 old case design (for serial numbers below 80,000) ... 5 - 4
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MR10 Neonatal Respiration Monitor
SIMS Graseby Ltd.
Abbreviations The following list shows the abbreviations that have been used within this Manual. Abbrev.
Item
ABS
Acrylonitrile butadiene styrene
C
Capacitor
D
Diode
dB
Decibel
DSP
Digital switching processor
Hz
Hertz
IC
Integrated circuit
kHz
Kilo Hertz
µL
Microlitres
LED
Light emmitting diode
PC
Polycarbonate
PCB
Printed circuit board
Pf
Picofarad
Pl
Plug
R
Resistor
Sec
Second
Sk
Socket
V
Volts
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MR10 Neonatal Respiration Monitor
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SIMS Graseby Ltd.
M R 1 0 Te c h n i c a l S e r v i c e M a n u a l
SIMS Graseby Ltd.
MR10 Neonatal Respiration Monitor
Chapter 1
1 Introduction The MR10 Neonatal Respiration Monitor is capable of continuously monitoring the respiration of infants up to the age of 18 months, and will give audible warnings and visual alarms if the infant stops breathing for more than the pre-set selected time. The Respiration Sensor consists of an encapsulated foam pad connected to a plastic tube. Expansion of the babys abdomen (with each breath) produces a change in pressure in the tube; this change is detected by the Monitor which shows the following:
a flashing green light if the ON 10 sec alarm delay button is selected or an orange light ON 20 sec alarm delay button is selected
an audible clicking sound.
If the baby stops breathing the condition is called apnoea. After a programmable preset delay (10 or 20 seconds depending on which alarm delay was selected) an apnoea is indicated by both audible and visual alarms.
Case design The MR10 Neonatal Respiration Monitor has two different types of case design, although the actual monitor operates exactly the same. This manual covers both versions of the MR10 case design, where differences occur within the manual they are refered to as the old case or new case design. The 2 types of design are shown on the next page.
the old case design covers monitors with serial numbers from 30,000 to 80,000 see Figure 1-1.
the new case design covers monitors with serial numbers from 80,000, see Figure 1-2.
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Figure 1-1 MR10 old case design (for serial numbers from 30,000 to 80,000)
Figure 1-2 MR10 new case design (for serial numbers from 80,000)
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MR10 Neonatal Respiration Monitor
Specification
1
Dimensions: Old case design 159 x 77 x 24 mm (H x W x D) for serial number below 80,000 New case design 170 x 85 x 30 mm (H x W x D) for serial numbers above 80,000
Weight: Old case design 240 grams (with batteries fitted). New case design 275 grams (with batteries fitted).
Indicators A green LED is lit when the 10 sec. Alarm delay button is set A orange LED is lit when the 20 sec. Alarm delay button is set
Sensitivity: When delivered, the monitor will be adjusted to detect breathing within certain limits. These limits are defined in terms of a pneumatic signal connected to the transducer inlet port. This signal is measured in microlitres (µ1) of air volume (limits 0.23 µ1 to 0.37 µ1).
Timing accuracy: + /- 0.8% or 0.5 second, whichever is the greater.
Signal detection and filtering: The monitor filters the respiration signal before the breath detection process. This removes features of the signal which could otherwise cause erroneous results. This includes removal of signals caused by movement, the unwanted DC component of the pneumatic signal, electrical interference (e.g. mains hum), and the cardiac pressure pulse (which is reduced in intensity by the low pass filter). The monitor expects the breathing rate to be between 40 and 140 per minute (this corresponds to a frequency range of 0.67 Hz to 2.3 Hz). The filter type is bandpass, with a frequency response of 0.5 Hz to 3.0 Hz (-3 dB). The presence of a breath is detected by a threshold comparator. The threshold is set to detect the inhalation part of the signal; it will be near the beginning of the inhalation for a large signal but a small signal will not be detected until later. The filter also introduces a time lag into the detection process.
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MR10 Neonatal Respiration Monitor
Batteries: 4 x 1.5 V (6 V), type IEC, LR6 (AA size), e.g. Duracell MN1500 (alkaline).
1
The battery life should be approximately 60 days with continuous use (with up to 150 alarms, each of 2 minutes duration). SIMS Graseby advises users not to use batteries other than the alkaline type. This is because the life of other battery types is much lower, and the low battery indication is less effective with non alkaline cells.
Low battery indicator The low battery LED lights orange with each breath, when the supply voltage is 3.5 to 4.4V. The monitor produces a non-resetable alarm if the supply voltage falls 0.5 V ±0.1V below the voltage at which the primary low battery detector is triggered.
External sensor: SIMS Graseby disposable item for single use (part No. 0108-0007).
Environmental conditions: Temperature range:
Operating 10 °C to +40 °C Storage -10 °C to +55 °C
Humidity range:
Operating 30 to 75 % RH Storage 10 to 95 % RH
Pressure range:
Operating 700 hPa to 1060 hPa Storage 500 hPa to 1060 hPa
Alarm: Alarm limits:
Adjustable to 10 or 20 seconds
Alarm output:
Visual (red indicator lamp) and audible (3 kHz pulse)
Materials used Monitor:
Case:
ABS, Brass inserts, Acrylic
Adhesive: PVC All metal components are of stainless steel, the printed circuit boards are made of epoxy glass fibre. Packaging:
Expanded polystyrene foam, Corrugated cardboard
Respiration Sensor:
PVC, ABS
Operating position: Any. A loop is provided on top of the monitor to allow it to be attached to a suitable fixing for vertical operation using the hanging strap supplied with the monitor.
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MR10 Neonatal Respiration Monitor
Standards
1
Electrical Safety An electrical safety classification in the international safety standard for medical electrical equipment, Type BF. If the Monitor is used as intended there will be no risk of a serious electrical shock. The Monitor is not suitable for direct connection to the heart.
EMC Law relating to electromagnetic compatibility, Group 1, Class B, emitted RF radiation to EN55011:1991, suitable for domestic use.
Design Standards EN 60601-1, EN 60601-1-2
Fluid Ingress Protection 0473
IPX1 In the normal operating position the Monitor is protected against drops of water falling vertically onto it. It is not safe to use the Monitor in more severe wet conditions.
CE Marking The CE mark demonstrates that the Monitor conforms to the requirements in the European Council Directive 93/42/EEC concerning medical devices. The number 0473 identifies the Notified Body under which the Quality Systems operated within SIMS Graseby Ltd are assessed.
Disposal When the time comes to dispose of the Monitor, its batteries, or any of its accessories, do so in the best way to minimise any negative impact on the environment. You may be able to use special recycling or disposal schemes. To find out about these contact your local waste disposal service. Separate any other parts of the equipment where arrangements can be made for their recovery, either by recycling or energy recovery. Important: Existing national or local regulations concerning waste disposal must take precedence over the above advice.
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Chapter 2 Introduction The SIMS Graseby Respiration Sensor is connected to a sensitive capacitive transducer that is mounted inside the monitor. The transducer consists of a fixed plate and a moving plate, both made of metallised film.
2
As the baby breathes, the sensor detects the abdominal movements caused by the babys respiration. This in turn causes minute air movements which are detected by the transducer and are passed to the associated circuits. The monitor incorporates a high integration silicon chip (see Fig. 2.1) that contains a digital signal processor; a signal conditioning circuit; the alarm and timing logic circuits, and a low battery detection circuit.
DIGITAL SIGNAL PROCESSOR
CLOCK OSCILLATOR MHZIN1
XTAL1
MHZIN2
XTAL2
CLOCK CLOCK RCOSCADC
RC OSCILLATOR ADC RCOSC1
RCOSC1 RCOSC2
RCOSC2
RCOSC3
RCOSC3
SENS RESET
OUT
BREATH
TESTBAR
TESTBAR
SENSITIVITY ADJUST LOGIC SENS0 SENS1 SENS2 SENS3
SENS0 SENS1 SENS2 SENS3
TESTOUT
TESTOUT
20 BIT SIGNATURE ANALYSER SENS
VDD
ALARM LOGIC INIT
PWMOFF
SOUND
SOUND
LEDLB LED10S LED20S LAMPALM EXTALM
LEDLB LED10S LED20S LAMPALM EXTALM
BREATH
SEC10
SEC10
SEC20
SEC20
RESET
RESET
OFF
OFF LOWBAT
LOW BATTERY DETECTOR LBAT
LBAT
LOWBAT
GM1185-A
Figure 2.1 Block diagram of silicon chip
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Circuit Description Master Clock The timing for the system is controlled by a lM Hz ceramic resonator, X1 (see page 7-5), with associated components C3, C4, R6. Loading this circuit, for example with an oscilloscope probe, may prevent the oscillator from starting. Connect the probe after the monitor is operating.
2
Transducer oscillator The transducer is used in an RC oscillator, the frequency of which is measured and compared with the master clock. At ICI, pin 25, a square wave should be present, at a frequency of about 6.5 kHz. This frequency varies if a pneumatic signal is injected into the transducer port. The transducer oscillator is controlled by the Digital Signal Processor (DSP). The square wave occurs in a burst of 16 cycles. The oscillator is restarted by the system every 7.8 ms. This circuit has a separate power pin (pin 27) to ensure the stability of the oscillator during supply voltage fluctuations, that may be caused by the alarm. C7, R11 and D1 provide voltage stabilisation.
Alarm circuit The piezo-electric sounder (X2) is used in a self-oscillating circuit. Q2, R1, R2, R9 and L1 form this circuit. The inductor provides voltage boosting to increase the sound level. D3 protects ICI from voltage transients generated by the alarm oscillator.
Visual indicators The three rectangular LEDs (LED 1, 2 and 3) are driven directly by ICI, with resistors R4 and R5 providing current limiting. The red alarm light (LED 4) is a special high brightness device which is driven through transistor Q1.
Battery protection D2 prevents ICI from being damaged if the batteries are reversed.
Sensitivity adjustment The link block LK1 provides 16 sensitivity settings, which allows the monitor to be adjusted to give a sensitivity to the stated specification. The sensitivity adjustment procedures must be carried out using the Graseby Apnoea Sensitivity Test Rig kit (Part No. 0512-0114). The part number for the Instruction Leaflet for using the Graseby Apnoea Sensitivity Test Rig is 0512-0116.
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MR10 Neonatal Respiration Monitor
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Figure 2.2 Circuit diagram
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