SIMS Graseby MR10 Neonatal Respiration Monitor Instruction Manual

MR10 Neonatal Respiration Monitor Instruction Manual

0473

MR10 Neonatal Respiration Monitor

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 Limited reserves the right to make changes without notice both to this publication and to the product which it describes. SIMS Graseby Limited seek to constantly improve its products, therefore, the specification for the MR10 is subject to change. ©

SIMS Graseby Limited 1998

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 SIMS Graseby Limited. SIMS GRASEBY LIMITED, Colonial Way, Watford, Hertfordshire, United Kingdom. WD2 4LG Tel: (+44) (0)1923 246434 Fax: (+44) (0)1923 231595 Registered in England. Company No. 995550

Instruction Manual

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MR10 Neonatal Respiration Monitor

Introduction Thank you for choosing a SIMS 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 using the Monitor.

Safety Warnings and Cautions •

If the Monitor alarms, before doing anything else make sure the baby is safe and comfortable.

•

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

•

The Monitor is not intended to be used on adults or children over 18 months old.

•

Do not use the Monitor in the presence of flammable anaesthetic gases or in an oxygen enriched atmosphere. It may increase the risk of a fire or explosion.

•

Do not immerse the Monitor in any liquid. It is not waterproof and the performance will be affected.

•

Do not use the Monitor outside its temperature range. The performance will be affected.

•

Do not use mobile telephones nearer than 1 metre to the Monitor. Although there have been no confirmed reports of interference with the operation of the Monitor, following this advice will reduce any risk.

•

Do not wipe the Monitor with organic cleaning solvents or strong disinfectants. The plastic case may be damaged.

•

Do not route the Respiration Sensor tubing near the baby's neck. Careful routing of the tubing is important to avoid it accidentally choking the baby.

•

The Respiration Sensor is intended for ‘single patient use’. Using the Sensor on more than one baby can cause cross-infection.

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Instruction Manual

MR10 Neonatal Respiration Monitor It is not known why some babies stop breathing. The following advice may help to reduce the risk of this happening: · position the baby on its back, · do not smoke and avoid smoky atmospheres, · do not let the baby get too hot, · contact a doctor immediately if the baby is unwell. The Monitor should only be used in the home environment under the direction of a doctor. Parents or carers must have the Monitor’s operation fully explained to them before using it. It is also essential that the parents or carers are able to use the most recent infant resuscitation techniques. 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 SIMS Graseby representative or SIMS Graseby Customer Care (Technical) Department.

Contents

Page

Introduction ... ii Safety Warnings and Cautions ... ii Overview of the Monitor ... 1 Batteries ... 1 Checking the alarm ... 3 Attaching the Resp. Sensor onto the baby ... 3 How to use the Monitor ... 4 If the alarm sounds ... 5 Faults, causes and actions ... 6 Care and maintenance ... 6 Cleaning ... 6 Disposal ... 7 Technical and performance specification ... 7 Symbols and their meaning ... 8 Figure 1. Front view of MR10 ... 2 2. Respiration Sensor placed on the baby ... 4

Instruction Manual

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MR10 Neonatal Respiration Monitor

Overview of the Monitor The SIMS Graseby MR10 Neonatal Respiration Monitor is capable of continuously monitoring the respiration of babies up to the age of 18 months and will give audible warnings and show visual alarms if the baby stops breathing for more than a set time. When a baby is being monitored it is preferable that the carer remains within both visual and audible range of the Monitor so that the alarms can be seen and heard. A pneumatic abdominal sensor is used to measure respiratory movement. This Respiration Sensor consists of an encapsulated foam pad connected to a plastic tube. Expansion of the baby’s 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 (10 sec.) or an orange light (20 sec.), an audible clicking sound.

If a baby stops breathing the condition is called apnoea. After a programmable preset delay (10 or 20 seconds) an apnoea is indicated by both audible and visual alarms. The MR10 only informs of an apnoea attack, it cannot prevent an apnoea attack.

Batteries The four LR6 (AA size) alkaline batteries are inserted into the top rear of the Monitor. Alkaline batteries are recommended in order to obtain the best usage from the Monitor. Under most conditions the batteries should last for up to three months. To remove the battery cover push down and slide the cover away from the Monitor. If installed, remove the four used batteries. Fit four new batteries (series connected) as shown in the diagram on the inside of the Monitor, and then slide the cover into place until it clicks. If the batteries are not inserted correctly the Monitor will ‘not’ work, but no damage will be done. When using the Monitor always have at least one spare set of batteries available. Remove the batteries if the Monitor is not going to be used for an extended period of time. Batteries low, first alarm: the orange low battery light ( - + ) will flash to indicate that the battery power is low. The Monitor will continue to operate normally for up to 36 hours. Change the batteries as soon as possible. Page 1

Instruction Manual

MR10 Neonatal Respiration Monitor

1 11 14

10 9 8

2

7 3

13

4 6

5 12

GM0804-A

ITEM:

1. Hanging loop. 2. Alarm light (red). 3. 10 second breath light (green). 4. 20 second breath light (orange). 5. OFF button. 6. Inlet socket. 7. 20 sec. apnoea alarm button. 8. 10 sec. apnoea alarm button. 9. Reset button. 10. Alarm sounder. 11. Low battery light (orange). 12. Respiration Sensor. 13. Sensor connector. 14. Battery cover.

Figure 1 Front view of MR10 Instruction Manual

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MR10 Neonatal Respiration Monitor Batteries exhausted, second alarm: if the batteries are not renewed when the low battery flashing indication is given and the Monitor remains in operation, then eventually when the batteries are exhausted, a continuous audible alarm will sound. This alarm cannot be cancelled. Renew all four batteries. Checking the alarm Each time the Monitor is used it must be checked to ensure that the audio/visual alarm is functioning correctly, as detailed below. Switch the Monitor on by pressing ON 10sec . The Monitor will confirm this selection with a beep and a green breath light. After 10 seconds an alarm will sound accompanied by the flashing red alarm light. Cancel the alarm by pressing RESET . Switch off the Monitor by pressing hold for OFF for two seconds, which the Monitor confirms with a beep. Attaching the Respiration Sensor onto the baby 1. Only use the SIMS Graseby Respiration Sensor REF 0108-0007. 2. Ensure the baby's abdomen is clean and dry. 3. Secure the Sensor's foam pad with a 50 mm wide and 100 mm long piece of hypo-allergenic surgical tape as shown in Figure 2. The best position is to either side of the lower part of the abdomen, below the navel. Ensure the tape is placed over both the pad and the tube. Feed the tube down the baby's legs. If clothing is worn, feed the tube down the leg underneath the clothing. This way the tubing cannot get round the baby's neck.

Correct and careful routing of the tubing is important in order to avoid the risk of the tubing becoming entangled around the baby's neck.

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Instruction Manual

MR10 Neonatal Respiration Monitor

50 mm

100 mm

GM0806-A

Figure 2 Respiration Sensor placed on the baby

How to use the Monitor 1. It is important to ensure that the Respiration Sensor connector is pushed firmly into the Monitor inlet socket using a slight twisting action. Do not apply excessive pressure. 2. With the Sensor attached to the Monitor, switch on the Monitor by pressing ON 10sec or ON 20sec thus selecting the time for the delay. 3. For every breath detected, the Monitor will make a clicking sound accompanied by a green flashing light ON 10sec or, an orange light ON 20sec . The click can be silenced by simultaneously pressing RESET and the selected alarm delay. Restore the click by repeating the above procedure. To change the alarm delay press the other alarm button. When the Monitor is first switched on there may be a small delay before it starts to detect the baby's breaths. 4. When the selected alarm time is breached an audiovisual alarm is triggered, which can be switched off by pressing RESET . 5. Should the baby start to breath again before RESET is pressed then the audible alarm will stop, but the red alarm light will continue to flash for another 60 seconds. Instruction Manual

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MR10 Neonatal Respiration Monitor 6. To switch the Monitor off, press hold for OFF for two seconds. The Monitor will confirm with a beep. 7. The best position for the Monitor is outside or at the bottom of the cot. The baby can also be monitored at any other time, e.g. in the pram, car seat etc. Always keep the Monitor out of reach of the baby. 8. When using the Monitor it is essential to be within earshot of the Monitor so that any alarm can be heard at all times. 9. To maintain the Monitor's effectiveness replace the Respiration Sensor after 7 days use.

If the alarm sounds If the Monitor alarms, before doing anything else make sure the baby is safe and comfortable. 1. Go to the baby but do not panic. 2. If the baby has stopped breathing carry out the resuscitation techniques that you have learned and immediately see that a doctor is called. 3. If the audible alarm has stopped sounding, but the alarm light is still flashing, then the baby has not taken a breath within the set alarm delay interval, but has taken a breath since the alarm sounded. Press RESET to cancel the alarm light and watch the baby for a while. If the alarm sounds again, confirm that the Monitor detects the breathing by checking the (audio) visual indicators, i.e. the click and the green or orange flashing light. 4. If the alarm continues sounding, stop it by pressing and look at the baby.

RESET

5. If the baby is a good colour and breathing, but there are no (audio) visual signals, then the system is not working correctly (refer to faults and possible causes below).

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MR10 Neonatal Respiration Monitor

Faults, causes and actions 1. Fault: Monitor completely inactive. Cause: Batteries are not fitted, connected incorrectly or they are exhausted. Action: Check that the batteries are fitted correctly, or if exhausted replace all four. 2. Fault: No breath signals registering. Cause: Sensor not connected to the Monitor. Action: Make sure that the Sensor connector is inserted in the Monitor's inlet socket, using a twisting motion. Alteratively, the Sensor pad has become loose on the baby's abdomen. Remove the Sensor, clean and dry the baby's skin. Using fresh tape apply a new Sensor. 3. Fault: Monitor has become defective. Cause: Internal fault. Action: Test by pressing gently with a finger over the inlet socket without the Sensor connected. This should produce signals on the Monitor, if it does not then contact a qualified SIMS Graseby service engineer.

Care and maintenance When used as described in these instructions the Monitor does not require any routine maintenance apart from replacing the batteries and occasional cleaning. It is recommended that the performance of the Monitor is checked at least annually. If the Monitor is damaged in any way the performance must always be checked before it is used again.

Cleaning The body of the Monitor should be cleaned when necessary by wiping it over with a cloth lightly moistened with a disinfectant solution.

Instruction Manual

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MR10 Neonatal Respiration Monitor

Disposal When the time comes to dispose of the Monitor, accessories or packaging 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 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.

Technical and performance specification Type:

• • • •

neonatal respiration monitor with passive pneumatic sensing system. internal low voltage power source. audible and visual alarm indicators. digital electronic filtering and timing.

Alarm delays: 10 seconds or 20 seconds, selectable. Controls:

ON 10sec and ON 20sec alarm delays. RESET and hold for OFF push buttons.

Alarm:

audible, pulsed 3 kHz. Visual, red solid state lamp.

Indicators: green (on 10 sec), orange (on 20 sec), and orange (low battery) solid state lamps. External sensor:

Graseby Respiration Sensor REF 0108-0007.

Battery:

4 x 1.5 V (6 V) primary alkaline, IEC LR6 type.

Battery life:

60 days continuous use, and depends on the operating conditions.

Size:

159 x 77 x 24 mm.

Weight:

240 grams, including batteries.

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Instruction Manual

MR10 Neonatal Respiration Monitor Operating mode-continuous.+10° C to + 40° C. 30% to 75% RH conditions: (non-condensing), 700 hPa to 1060 hPa. Transport and storage conditions: -40° C to +70° C, 10% to 100% RH (non-condensing), 500 hPa to 1060 hPa. Materials: case is ABS, labels are PC. Metal parts are stainless steel and the circuit boards are epoxy glass fabric. Electrical safety: complies with IEC 601-1:1988. Type BF Applied Part for protection against electric shock. Water ingress protection: IPX1 (IEC 529). EMC:

complies with EN 60601-1-2:1993 for emissions and immunity to electromagnetic disturbances. Group 1 Class B for emitted RF radiation according to EN 55011:1991 making it acceptable for use in domestic establishments.

Medical Device Directive 93/42/EEC: CE marked under Annex ll, risk class llb (active medical device). Notified Body: AMTAC (0473). Quality system standards used: EN ISO 9001 and EN 46001.

Symbols and their meaning 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. 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. Refer to the accompanying instructions on how to use the Monitor. The instructions are all in this manual. CE Mark 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 SIMS Graseby Ltd. are assessed.

Instruction Manual

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MR10 Neonatal Respiration Monitor

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Instruction Manual

IN AN EMERGENCY CONTACT:

SIMS Graseby Limited Colonial Way, Watford, Herts, UK, WD2 4LG Tel: +44(0)1923 246434 Fax: +44(0)1923 231595

GB Part No. 0126-0031-D February 1998

PRINTED ON RECYCLED PAPER

© SIMS Graseby Ltd. 1998