SIMS Graseby MR10 Neonatal Respiration Monitor Instruction Manual (New Shape)

MR10 Neonatal Respiration Monitor

Instruction Manual

Published by Graseby Medical Limited. All possible care has been taken in the preparation of this publication, but Graseby Medical Limited accepts no liability for any inaccuracies that may be found. Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes. Copyright © 2002 Graseby Medical Limited 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 or by any means without the prior permission of Graseby Medical Limited. GRASEBY MEDICAL LIMITED Colonial Way, Watford, Hertfordshire, United Kingdom, WD24 4LG Telephone: Fax: Web:

(+44) (0)1923 246434 (+44) (0)1923 231595 www.graseby.co.uk

Registered in England. Company number 995550

Trademarks and acknowledgements: Graseby and Smiths are registered trademarks of the Smiths Group plc. All other trademarks are acknowledged as the property of their respective owners.

Warnings and Cautions

Graseby Medical Ltd.

Wa r n i n g s 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.

WARNING: The MR10 only informs of an apnoea attack, it cannot prevent an apnoea attack.

2.

WARNING: If you suspect that the Monitor is not operating correctly, do not use and return to Graseby Medical or a suitably qualified technician for testing.

3.

WARNING: Only use the Graseby Medical Respiration Sensor, REF 0108-0007. The performance of the Monitor can only be guaranteed with this Sensor.

4.

5.

6.

7.

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.

MR10 Instruction Manual

8.

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.

9.

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.

10. 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. 11. WARNING: If the Monitor alarms, before doing anything else make sure that the infant is safe and comfortable and not in a dangerous situation. 12. 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. 13. 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. 14. 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.

Warnings and Cautions

Graseby Medical 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.

CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the Monitor must not be carried out.

2.

CAUTION: Do not autoclave, steam sterilise, ETO sterilise or subject the Monitor to temperatures in excess of 45° C (113° F). Excessive temperatures may cause damage to the Monitor.

3.

CAUTION: Do not use unapproved cleaning agents.

4.

CAUTION: To prevent serious damage to the Monitor it must not be immersed in any liquids or exposed to strong organic solvents. Wipe off spills immediately. Do not allow fluid or residues to remain on the Monitor. Additionally, the Monitor is not designed to allow it to be sterilised. Failure to observe these cautions may cause internal damage to the Monitor.

MR10 Instruction Manual

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Contents Introduction ... 1 - 2 Overview of the Monitor ... 1 - 2 Parts of the Monitor ... 1 - 3 Alarm system test ... 1 - 4 Using the Monitor ... 1 - 5 Attaching the Respiration Sensor ... 1 - 5 Monitor set up ... 1 - 6 Switching the MR10 on ... 1 - 6 Silencing the “clicking sound” ... 1 - 6 Changing the alarm delay ... 1 - 6 Checking alarm output ... 1 - 6 Monitoring the infant ... 1 - 7 Switching the MR10 off ... 1 - 7

If the alarm sounds ... 1 - 7 Batteries ... 1 - 8 Battery alarm ... 1 - 8 Battery replacement ... 1 - 8

Faults, causes and actions ... 1 - 9 Care and maintenance ... 1 - 10 Maintenance ... 1 - 10 Cleaning the Monitor ... 1 - 10 Respiration Sensor ... 1 - 10

Technical specification ... 1 - 11 Standards ... 1 - 12

MR10 Instruction Manual

1 - 1

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Introduction Thank you for choosing a Graseby MR10 Neonatal Respiration Monitor. This Instruction Manual contains important information on operating and looking after your Monitor. To become completely familiar with all the Monitor’s features please take time in reading this manual before use.

the direction of a clinician, who will provide full instruction in the handling of the Monitor where necessary. It is also essential that the parents or carers are able to use the most recent infant resuscitation techniques in emergency (if necessary consult a clinician).

It is not known why some infants stop breathing. The following advice may help to reduce the risk of this happening:

It is important to use the Monitor correctly. Always make sure the alarms are working by testing them every time the Monitor is used. If you are unsure about any aspect of the Monitor’s use contact your clinician.

• position the infant as advised by your clinician, • do not smoke near the infant and avoid smoky atmospheres, • take steps to prevent the infant becoming too hot. • contact a doctor immediately if you suspect that the infant is unwell. The Monitor should only be used under

Overview of the Monitor The Graseby MR10 Neonatal Respiration Monitor is capable of continuously monitoring the respiration of infants up to the age of 18 months and will give audio visual alarms if the infant stops breathing for more than a pre-set time. When an infant is being monitored it is essential that the user remains within visual and audible range of the Monitor so that the alarms can be seen and heard. WARNING: The MR10 only informs of an apnoea attack, it cannot prevent an apnoea attack.

1 - 2

The breathing signal is picked up by a soft, foam-filled Sensor (Respiration Sensor) that is attached to the infant’s abdomen. During breathing, expansion of the abdominal wall causes a small amount of air to pass through the Sensor and tube to the Monitor. This triggers an audible click and simultaneous visual indication. The Monitor is powered by 4 LR6 (AA) alkaine batteries, for further information see page 1-8, Batteries.

MR10 Instruction Manual

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Pa r t s o f t h e M o n i t o r

MR10 Instruction Manual

1 - 3

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Alarm system test The operation of the alarm system must always be checked as follows before the Monitor is used: • Prior to connecting a Respiration Sensor, press the ON 10 sec alarm delay button. The MR10 confirms the button selection by a short beep and the ON 10 sec light briefly illuminates. • The audio visual alarm (flashing red alarm indicator) should trigger after 10 seconds. • The MR10 is turned off by pressing

1 - 4

the HOLD FOR OFF button. (Keep the button pressed until you hear a short beep) • If the Alarm system test is unsuccessful for further information see page 1-9, Faults causes and actions.

WARNING: If you suspect that the Monitor is not operating correctly, do not use and return to Graseby Medical or a suitably qualified technician for testing.

MR10 Instruction Manual

2

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Using the Monitor IMPORTANT: Carry out the Alarm system test each time the MR10 is used, see page 1-4, Alarm system test.

Attaching the Respiration Sensor 1. Clean and dry the infant’s abdomen. 2. The most suitable position for attaching the Respiration Sensor is just below the navel, slightly to the left or right. Fix the Respiration Sensor pad and tube using hypo allergenic tape 50 mm wide and 100 mm long. Position the Sensor tube down between the infant’s legs to the Monitor, so that it is away from the neck, or so that the infant cannot play with it (see illustration). The Respiration Sensor can be worn under clothing (even nappies). In this case, however, ensure that the Sensor tube is passed through the clothing.

3. It is important to ensure that the Respiration Sensor connector is pushed firmly into the Monitor’s connector socket using a slight twisting action. Do not apply excessive pressure. NOTE: When attaching the Respiration Sensor pad ensure that the tape is long enough and does not interfere with the Respiration Sensor. The tape should not be stretched too tightly over the Sensor pad. Only the Graseby Medical Respiration Sensor should be used, part number 0108-0007.

WARNING: Only use the Graseby Medical 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.

MR10 Instruction Manual

1 - 5

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Monitor set up Switching the MR10 on Always check that the Monitor has been fitted with batteries, see page 1-8, Batteries. With the Respiration Sensor attached to the Monitor, switch the Monitor on by pressing either the ON 10 sec or ON 20 sec alarm delay button. The choice of which alarm delay button to use should always be determined by a clinician. • The ON 10 sec alarm delay button, will alarm if no breath is detected after 10 seconds. • The ON 20 sec delay button, will alarm if no breath is detected after 20 seconds. For every breath detected, the Monitor will make a clicking sound accompanied by a green ON 10 sec or, an orange ON 20 sec flashing light. When the Monitor is first switched on there may be a small delay before it starts to detect the infant’s breaths. If the selected alarm time is breached an audiovisual alarm is triggered, this can be silenced by pressing , see page 1-7, If the alarm sounds. Should the infant start to breath again before is pressed then the audible alarm will stop, but the red alarm light will continue to flash for another 60 seconds.

Silencing the “clicking sound” The clicking which sounds each time a breath is detected, can be silenced by simultaneously pressing the button and the selected alarm delay button.

1 - 6

To restore the click repeat the above procedure. However, breathing continues to be indicated by the flashing indicator lamp.

Changing the alarm delay If the Monitor is set to an alarm delay interval of 10 seconds and a 20 second alarm interval is required. This can be selected by pressing the ON 20 sec button without switching the Monitor off. You can also change from a 20 second alarm delay to a 10 second by pressing the ON 10 sec button.

Checking alarm output To check the alarm output, remove the Respiration Sensor connector from the Monitor; the audible alarm should sound after 10 seconds (or 20 seconds), and the alarm indicator flashes. Replace the Respiration Sensor connector, the audible alarm stops and the visual alarm continues to flash for about 60 seconds. The MR10 immediately reverts to the monitoring function. However, in order to save battery power it is recommended that the visual alarm be cancelled as soon as possible by pressing the button.

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.

MR10 Instruction Manual

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Monitoring the infant While the infant is being monitored by the MR10 it is essential that the user remains within audible and visual range of the Monitor.

To maintain the Monitor’s effectiveness, the Respiration Sensor should be replaced after a maximum of 7 days to minimise false alarms.

Switching the MR10 off

If using the Monitor in an infant’s cot position it away from the infant i.e. at the bottom of the cot or use the hanging strap (supplied with the Monitor) and hang the Monitor from the cot bars. The infant can also be monitored at any other time, for example: in a buggy, car seat etc.

To switch the Monitor off press the HOLD FOR OFF button (for about 2 seconds) until a short beep is heard.

WARNING: The Monitor is not suitable for use with adults or children over the age of 18 months.

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 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: 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.

If the alarm sounds WARNING: If the Monitor alarms, before doing anything else make sure that the infant is safe and comfortable and not in a dangerous situation.

1. Go to the infant but do not panic. 2. If the infant has stopped breathing carry out the resuscitation techniques that you have learned and immediately seek medical assistance. 3. If the red alarm indicator is flashing but the audible alarm is silent, this shows that a previous alarm condition was present. Press the MR10 Instruction Manual

button to cancel the visual alarm indication and observe the infant for a while. If an audible alarm sounds again, carry out the Alarm system test see page 1-4, Alarm system test. 4. If the audible alarm is repeated, press the button again and observe the infant. 5. If the infant is safe and breathing normally but the Monitor is not indicating the infant’s breath, there is possibly a technical fault, see page 1-9, Faults, causes and actions. 1 - 7

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Batteries Battery alarm

2. Remove the old batteries

If the battery power is reduced, the low battery symbol - + will flash. Although the MR10 will continue to operate for a time, for safety the batteries should be replaced immediately.

3. Insert 4 new batteries into the battery compartment. Observe correct polarity (see illustration below).

NOTE: If an audible alarm sounds in addition to the low battery symbol, and cannot be cancelled by pressing the reset alarm button, the batteries must be replaced immediately, otherwise safe respiration monitoring can no longer be guaranteed. The operational life of the batteries depends on the frequency of the alarms. However, a service life of approximately 60 days can generally be assumed. The batteries should be removed if the MR10 is not to be used for a prolonged period. It is recommended that at least one full set of spare batteries is always available.

Battery replacement 1. To replace the batteries open the battery compartment cover located on the rear of the Monitor. Insert a small coin or other suitable tool into the locating screw on the cover. Turn the screw anti-clockwise and remove the cover.

4. Close the battery compartment cover. 5. Carry out the Alarm system test before use, see page 1-4 Alarm system test. NOTE: • Old batteries should not be disposed of in household waste. • If after inserting new batteries no clicking signal is produced when the Sensor pad is pressed, use another set of new batteries. • It is important to bear in mind that even new batteries can be discharged after being stored for a long time.

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.

1 - 8

MR10 Instruction Manual

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Faults, causes and actions WARNING: If the Monitor alarms, before doing anything else make sure that the infant is safe and comfortable and not in a dangerous situation.

CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the Monitor must not be carried out.

Fault:

Cause:

Action:

Monitor does not work

No batteries fitted.

Fit new batteries.

Batteries fitted incorrectly.

Check that the batteries have been fitted as indicated in the battery compartment.

Batteries discharged.

Fit new batteries.

Respiration Sensor not connected to the Monitor.

Make sure that the Sensor connector is inserted in the Monitor's connector socket, using a twisting motion.

Sensor pad has become loose on the skin.

Remove the Sensor, clean and dry the infant's skin. Attach the Sensor pad with new hypo allergenic tape see page 1-5, Attaching the Respiration Sensor.

Internal fault.

Test by removing the Sensor tube from the Monitor (with a slight turning movement) and by pressing gently with a finger over the inlet socket. This should produce signals on the Monitor, if it does not the Monitor is faulty and must not be used. Contact a Graseby Medical or a suitably qualified technician.

Respiration Sensor is defective.

Attach a new Respiration Sensor to the Monitor, see page 1-5, Attaching the Respiration Sensor. If the Respiration Sensor still does not work, the Sensor maybe faulty, contact Graseby Medical.

No respiration signals

Monitor has become defective

MR10 Instruction Manual

1 - 9

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Care and maintenance Maintenance

Cleaning the Monitor

When used as described in these instructions the Monitor does not require any routine maintenance apart from replacing the batteries and occasional cleaning.

The Monitor should be wiped clean using only a cloth slightly moistened with a liquid disinfectant. Never use a dripping wet cloth.

It is recommended that the performance of the Monitor is checked at least annually by a qualified Graseby Medical engineer. If the Monitor is damaged in any way the performance must always be checked before it is used again. For details of technical and maintenance information, including annual checks, refer to the MR10 Technical Service Manual, part number 0514-0045. For further information, contact Graseby Medical Limited, Customer Care, an authorised technician or your local distributor CAUTION: Refer all service, repair and calibrations only to qualified technical personnel. Unauthorised modifications to the Monitor must not be carried out.

Refer to the MR10 Technical Service Manual, part number 0514-0045 for details of cleaning agents.

Respiration Sensor Sensors are single use items, they must not be cleaned or sterilized and with regular use should be replaced after a maximum of 7 days. Never use the same Sensor with more than one infant.

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 CAUTION: Do not autoclave, steam sterilize, ETO sterilise or subject the Monitor to temperatures in excess of 45°C (113°F). Excessive temperatures may cause damage to the Monitor. CAUTION: Do not use unapproved cleaning agents. CAUTION: To prevent serious damage to the Monitor it must not be immersed in any liquids or exposed to strong organic solvents. Wipe off spills immediately. Do not allow fluid or residues to remain on the Monitor. Additionally, the Monitor is not designed to allow it to be sterilised. Failure to observe these cautions may cause internal damage to the Monitor.

1 - 10

MR10 Instruction Manual

Graseby Medical Ltd.

MR10 Neonatal Respiration Monitor

Te c h n i c a l s p e c i f i c a t i o n Description

Neonatal respiration Monitor with passive pneumatic Sensor system. Battery-operated, visual and audible alarm output, digital electronic filtering and timing

Power supply

4 IEC type 6V LR6 (AA) alkaline batteries

Battery life

Approx. 60 days, depending on usage and number of alarms

Dimensions

170 x 85 x 30 mm (H x W x D)

Weight

275 g (including batteries)

Alarm limits

Adjustable to 10 or 20 seconds

Alarm output

Visual (red indicator lamp) and audible (3 kHz pulse)

Indicators

Green (10 sec.), orange (20 sec.)

Battery indicator

Orange (battery nearly discharged)

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 Law relating to electromagnetic compatibility, Group 1, Class B, emitted RF radiation to EN55011:1991, suitable for domestic use.

EMC

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:

Polyetheleyne foam, Corrugated cardboard

Respiration Sensor:

PVC, ABS

Note: all materials used in this product are latex free Accessories Respiration Sensor

Part number 0108-0007

Instruction Manual

Part number 0514-0035

MR10 Instruction Manual

1 - 11

MR10 Neonatal Respiration Monitor

Graseby Medical Ltd.

Standards 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. Design Standards

EN 60601-1, EN 60601-1-2 Fluid Ingress Protection

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 0473

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 Graseby Medical 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.

1 - 12

MR10 Instruction Manual

For further information, please contact your local distributor or Graseby Medical direct on +44 (0)1923 246434

Graseby Medical Ltd. Colonial Way, Watford, Herts, UK, WD24 4LG Telephone: +44 (0)1923 246434, Facsimile: +44 (0)1923 231595 http://www.graseby.co.uk Part No. 0514-0035-B June 2002 © 2002 Graseby Medical Ltd

Smiths Medical - A part of Smiths Group plc