RM15 Service Manual Rev 1.12 Feb 2021

Service Manual – RM15

Contents 1.

Introduction: ... 2

2.

Warnings & Cautions ... 2

3.

Controls & Indicators: ... 3

4.

Symbols: ... 3

5.

Spare Parts List: ... 4

6.

Routine Maintenance: ... 4

7.

Fault Finding:... 5

8.

Batteries: ... 6

9.

Opening & Closing the Case: ... 6

10. Replacing the Circuit Board: ... 7 11. Adjusting Sensitivity: ... 8 12. Replacing a Sounder: ... 8 13. Replacing Front Panel: ... 8 14. Replacing Case Rear: ... 8 15. Replacing the Strap Handle: ... 9 16. Attaching the Strap: ... 9 17. Technical Specifications: ... 10 Appendix A ... 11 Appendix B... 12

© 2020 Delta Medical International Ltd. All rights reserved. No part of this publication may be reproduced, translated, transmitted, transcribed, or stored in a retrieval system, in any form or by any means, without the prior permission of Delta Medical International. All possible care has been taken in the preparation of this manual, but Delta Medical International accepts no liability for any inaccuracies that may be found and reserves the right to make changes without notice to this publication and to the product.

Rev.:1.12 - 05-02-21

Page 1 of 12

Service Manual – RM15

1. Introduction: CAUTION: Service and maintenance must only be undertaken by a suitably qualified engineer or technician. If in doubt refer to Delta Medical International or your local supplier. The Respiration Monitor is used to continuously monitor the respiration of infants up to the age of 18 months. The Monitor will give audio and visual alarms if the infant stops breathing for more than a user-selected time. The respiration signal is picked up by a disposable pneumatic sensor which is attached to the infant’s abdomen. During breathing, expansion of the abdominal wall displaces a small amount of air in the sensor which is transmitted through an integral tube to the monitor. Each breath is detected by the monitor and triggers visual indication and an audible click if enabled. The Respiration Monitor only gives an indication of an apnoea event and cannot prevent it. The user must ensure all reasonable precautions and actions are taken. The unit consists of one printed circuit assembly mounted in a moulded plastic box with two sounders mounted internally to the case front panel and rear panel. The case has an externally accessible battery compartment designed to hold 3 off AA size alkaline batteries, each with a 1.5Vdc output, connected in series to give total output of 4.5Vdc. The unit is an approved medical device and should only be serviced by competent authorised staff. The instrument case is sealed to IP67 (with sensor attached) so it is important to ensure correct reassembly after any service to maintain this level of protection. This Manual should be read in conjunction with the Instruction Manual for the product.

2. Warnings & Cautions Service and maintenance should only be undertaken by a suitably qualified engineer or technician. If in doubt refer to Delta Medical International or your local supplier. Ensure work areas are clear, clean and free from any dirt before starting any service work. Always use correct type and size of screwdriver when removing and fitting screws. Only AA size 1.5V alkaline batteries must be used. Check case is correctly reassembled to preserve IP67 rating. If replacing case ensure serial number is correctly transferred. Verify correct performance after any service or repair work using designated test procedure. Do not autoclave, steam sterilise, ETO sterilise, immerse in fluids or expose the Monitor to high temperatures, in excess of 45°C. The screwdriver and batteries supplied with this product could be a choking hazard. Keep them away from small children.

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Service Manual – RM15

3. Controls & Indicators: Apnoea Alarm Indicator Respiration Indicator

Alarm Delay Indicators

Increase Delay Button Sounder On/Off Button Decrease Delay Button Sounder Off Indicator Low Battery Indicator Power On/Off Button

Alarm Cancel Button

Power On Indicator Sensor Input Socket

4. Symbols: Warning or Caution that could cause harm to the user or patient or damage to the product Refer to operating instructions

Power On/Off (standby) Respiration Sounder silence/enable

  Alarm Delay

 

Alarm Cancel button







Sensor input connector

+

Negative

Battery Polarity Positive

Type B applied part Battery compartment 3 x AA 1.5V cover

CE Mark, European MDD 93/42/EEC Dispose according to EU WEEE Directive

Manufacturer details

S/N

Low Battery indicator

Rev.:1.12 - 05-02-21

Alarm Delay increase/decrease

Page 3 of 12

Product Serial Number

Service Manual – RM15

5. Spare Parts List: Part No.

Description

NMA021

Strap, blue, RM15

NMA025

Screwdriver, Miniature

RM-120006

Front Label, RM15

RM-120003

Handle, RM15, for strap, supplied with screws and washers

RM-1200013

Main PCB Assembly, RM15, with input tubing fitted

RM-1200014

Case front panel, with label and sounder fitted

RM-1200015

Case rear, RM15, with input connector, handle, sounder and labels fitted

RM-UM-001

User Manual, RM15

6. Routine Maintenance: The following routine maintenance should be carried out at the intervals shown. Before each use:  Check there is no sign of damage or contamination to the monitor.  Check there is no sign of damage or contamination to the hanging strap if fitted.  Check the condition of the batteries.  Check alarm sounds after delay period if no sensor is connected.  Check the unit has been decontaminated in accordance to local infection control guidelines.  Check the unit registers breathing once connected to patient. Daily:  Check there is no sign of damage or contamination to the monitor.  Check there is no sign of damage or contamination to the hanging strap if fitted.  Check the condition of the batteries.  Check the unit is registering patient’s breathing.  Check alarm sounds after delay period if no sensor is connected. Annually (or at interval dictated by local guidelines if different):  Check there is no sign of damage or contamination to the monitor.  Check there is no sign of damage or contamination to the hanging strap if fitted.  Check the condition of the batteries.  Check the condition of the battery compartment screw and replace if necessary.  Check there is no sign of corrosion to the battery compartment terminals.  Check the condition of the battery compartment seal and replace if necessary.  Carry out Test Procedure as specified in Appendix A. Only if local policy and Risk Assessment allows, Test Procedure in Appendix B may be used as an alternative.

Rev.:1.12 - 05-02-21

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Service Manual – RM15

7. Fault Finding: The following table gives a guide to diagnosis of the cause of any fault. Ensure that the suggested causes / actions are carried out in the order shown. Symptom

Suggested Cause / Action

Strap comes loose

Check strap is passed through buckle in correct orientation

Unit will not turn on

Check On/Off button pressed for at least 2 sec. Check batteries are correct type and correctly fitted Fit new batteries Check PCB not loose inside case Check internal PCB connection to battery terminals Check supply voltage to PCB If no supply voltage replace case (battery compartment) If voltage present and still not working replace PCB

Unit will not turn off

Check On/Off button pressed for at least 3 sec. Check PCB not loose inside case If still not working replace PCB

Audio output volume low / No audio output

Check holes in front label are not blocked Check connections to both internal sounders are intact If only one sounder not working, replace sounder If both sounders not working replace PCB

Breath Sounder not working

Check breath silence button not pressed or stuck Remove sensor and check alarm sounds after delay period If alarm also not working check audio output as above If still not working replace PCB

Unit does not register breathing

Check sensor is correctly attached to baby Change sensor and see if problem resolved Check input connector is not obstructed Check internal input tubing is not kinked or obstructed Check internal input tubing is not detached or loose Check patient is no more than 18 months old Check sensitivity is in correct range (see Section 11) Increase sensitivity so breaths are detected at lower level If still not working replace PCB

Breath silence not working

Check PCB not loose inside case If still not working replace PCB

Breath LED not working

Check breath sounder is working If sounder working replace PCB If sounder not working check as “unit does not register breathing” above

Delay adjust not working

Check buttons pressed for at least 2 sec. Check PCB not loose inside case If still not working replace PCB

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Service Manual – RM15 Symptom

Suggested Cause / Action

Alarm not working (both audio and visual)

Check lack of signal lasts longer than Delay setting Check movement not creating artificial signal Check vibration not creating artificial signal Put tape over input connector and check alarm sounds If still not working replace PCB

Alarm LEDs not working

If sounder not working check “alarm not working” as above If alarm sounder is working replace PCB

Alarm audio not working

If breath sound not working check audio output as above If still not working replace PCB

Alarm silence not working

Check PCB not loose inside case Replace PCB

Device generates frequent false alarms

Check sensitivity is in correct range as described in Section 11 & Appendix A Increase sensitivity so breaths detected at lower level See also “unit does not register breathing” above

If it is not possible to diagnose the fault using above guide please return the unit to Delta Medical International or your local supplier for investigation, including as much detail about the fault as possible.

8. Batteries: Always check batteries used are of the type specified in the Operating Instructions. Always check batteries are fitted with correct polarity as shown inside the battery compartment. To change batteries open the compartment at the rear of the unit using a suitable sized screwdriver. Ensure the compartment is closed securely after replacing batteries to maintain seal.

9. Opening & Closing the Case: Opening the case: Remove the battery compartment cover and remove batteries. Remove 6 off crosshead screws holding the two case halves together. Note that the sounder connecting wires are short and fragile so ensure they are not stressed when opening the case. Carefully prise the case front panel from the case rear and place the front panel so that the sounder wires are not pulling. Remove the blue side pieces so they are not damaged.

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Service Manual – RM15 Closing the case: To close the case replace the blue side pieces, noting that they each need to be orientated so that the two notches fit over the corresponding spars in the case. Ensure that the grooves on each edge of the side pieces fit over the corresponding edges of the case and carefully push the two halves together so that the seal is made and the side pieces fit correctly and are not distorted. Replace the 6 screws, checking that they are all fully tightened. Then replace the batteries and battery compartment cover, checking the retaining screw is fully tightened.

10. Replacing the Circuit Board: Open the case as described earlier. Note the points on the PCB where the wires from the rear panel sounder are connected, as shown, and de-solder them so the sounder is disconnected. Disconnect the power input connection wires from the battery pack terminals as shown. Carefully disconnect the sensor tubing from the input to the pressure sensor on the PCB where shown.

Pressure Sensor

Remove the 4 screws securing the PCB to the case front panel, store them safely and carefully lift the PCB to allow access to the wires connecting the front panel sounder. Note the points on the PCB where the wires are connected and de-solder them so the sounder is disconnected. The PCB can now be removed. As the board uses surface-mount components there are no parts that are user serviceable and the complete assembly needs to be replaced. Re-solder the front panel sounder wires to the new PCB, ensuring the correct polarity as shown. Seat the PCB on the pillars on the front panel and secure using the 4 screws removed from the old board. Check the PCB is held securely and that the buttons can be operated. Reconnect the power input wires to the battery pack terminals. Re-solder the rear panel sounder wires to the new PCB, ensuring the correct polarity as noted when removing. Reconnect the sensor tubing by pushing the tube firmly over the barbed inlet on the pressure sensor and ensure it butts right up to the wall of the component. Close the case as described above. Carry out Test Procedure as specified in Appendix A. If local policy and Risk Assessment allows then the Test Procedure in Appendix B may be used as an alternative.

Rev.:1.12 - 05-02-21

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Service Manual – RM15

11. Adjusting Sensitivity: If the sensitivity test criteria cannot be met as described in the Test Procedure below, then adjust the sensitivity by adjusting the potentiometer shown until the unit meets the necessary performance characteristics specified. Sensitivity setting should be in the range 0.23µl to 0.37µl and should be adjusted using a Sensitivity Test Rig which is operated in accordance with its instructions for use. The setting required may vary according to the typical size and gestation of the patients being monitored.

12. Replacing a Sounder: Open the case as described earlier and determine which sounder needs replacing. It is prudent first to check that the problem is not due to any break in the connection wires or solder joints. As the sounders are glued to the case mouldings it is necessary to replace either the front panel or the case rear depending on which sounder has failed. Refer to instructions below for these.

13. Replacing Front Panel: Open the case as described earlier. Remove the 4 screws securing the PCB to the case, store them safely and carefully lift the PCB to allow access to the wires connecting the front panel sounder. Note the points on the PCB where the wires are connected and desolder them so the sounder is disconnected. Solder the front panel sounder wires to the PCB, ensuring the correct polarity. Seat the PCB on the pillars on the front panel and secure using the 4 screws removed from the old board. Check the PCB is held securely and that the buttons can be operated. Close the case as described above. Carry out Test Procedure as specified in Appendix A. If local policy and Risk Assessment allows then the Test Procedure in Appendix B may be used as an alternative.

14. Replacing Case Rear: Open the case as described earlier. Note the points on the PCB where the wires from the rear panel sounder are connected, as shown, and de-solder them so the sounder is disconnected. Disconnect the power input connection wires from the battery pack terminals as shown. Carefully disconnect the sensor tubing from the input to the pressure sensor on the PCB where shown. Pressure Sensor

Rev.:1.12 - 05-02-21

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Service Manual – RM15 The rear case is now removed and the new part can be fitted by reconnecting the sensor tubing. Push the tube firmly over the barbed inlet on the pressure sensor and ensure it butts right up to the wall of the component. Then reattach the speaker and power input wires, ensuring the correct polarity in both cases as noted above. Close the case as described above. Ensure that the serial number from the old case rear is transferred to the new rear serial number label. This is very important for Medical Device compliance. Carry out Test Procedure as specified in Appendix A. If local policy and Risk Assessment allows Test Procedure in Appendix B may be used as an alternative.

15. Replacing the Strap Handle: The handle should be fitted to the case with two self-tapping screws and washers supplied with handle, using screwdriver access holes in case. Open the case and remove the PCB as described above, although if careful it may not be necessary to de-solder the sounder wires. If there is silicone sealant in the two access holes carefully remove it (this was only fitted to early units and should not be replaced). Using the access holes, remove the two screws securing the handle to the case and the associated washers thus releasing the handle. Fit a new handle using the screws and washers provided by reversing the above process, ensuring the screws are tightened so the handle is fitted securely. After fitting check handle is securely attached.

16. Attaching the Strap: Attach the strap to the monitor, if required, by unclipping the buckles and passing the strap through the attachment loop at the top of the unit, then reattaching the loose clip as shown below. Check the orientation of the clip is correct or the strap will not be secure.



 The length of the strap can be adjusted by feeding the strap through the adjustment cleat in the appropriate direction.

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Service Manual – RM15

17. Technical Specifications: Parameter

Specification

Power Input

4.5V - 3 x AA (LR6) Alkaline Batteries

Power Consumption

32mW (typ.)

Power Input

4.5Vdc, 7mA (typ.)

Apnoea Alarm Interval

10, 15 or 20 sec (user selected)

Size

8.8 x 14.6 x 3.3cm (W x H x D)

Weight

0.3kg (including batteries)

Operating Temperature

+10°C to +40°C

Storage Temperature

-10°C to +55°C

Compliance

EN 60601-1, EN 60601-1-2, MDD 93/42/EEC

These specifications may change without notice due to continuous product improvement

Rev.:1.12 - 05-02-21

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Service Manual – RM15

Appendix A Test Procedure Procedure requires the use of a Respiration Simulator. Check the unit has no sign of any damage. Fit batteries. Power up the unit and check the power on/off light illuminates green. Press Power button for 1 second and release. Ensure the unit doesn’t turn off. Press Power button for 3 seconds and release. Ensure the unit turns off. Power up unit again. Set delay to 10, 15 and 20 sec in turn and check correct lights illuminate yellow. Power down and up again and check delay is still set to 20 sec (last setting). Set delay to 10 sec. Power down and up again and check delay is still set to 10 sec (last setting). Attach the respiration simulator to the unit and set simulator running at Normal respiration volume of 0.33μl. Check respiration click sounds and green light illuminates for each cycle. Check detection ceases if respiration volume is set to 0.23μl. If these test parameters are not met then adjust the sensitivity as described in the section on Adjusting Sensitivity above. Set the simulator to 0.33μl Press respiration sounder on/off button, check associated light illuminates yellow and click stops. Press respiration sounder on/off button and check associated light extinguishes and click re-starts. Turn simulator off and check audible and visual alarm (3 red lights) starts after 10 sec ±2 sec. Turn simulator on, check alarm continues until 3 breaths, then after 3 breaths sounder stops and lights continue flashing. Turn simulator off and check audible alarm sounds after 10 sec ±2 sec. Press Alarm Cancel and check audible and visual alarm stops and re-starts after 1 minute ±5 sec. Press Alarm Cancel, re-start simulator and check alarm does not recur after 1 minute ±5 sec. Change delay to 15 sec. Turn off simulator and check audible and visual alarm starts after 15 sec ±2 sec. Press Alarm Cancel and re-start simulator. Change delay to 20 sec. Turn off simulator and check audible and visual alarm starts after 20 sec ±2 sec. Press Alarm Cancel and re-start simulator. Set Delay to 10 sec. Turn off the unit. Remove batteries and attach a variable power supply to the battery terminals. Set output voltage of power supply to 4.5Vdc and turn it on. Turn on the apnoea monitor and check it is functioning by turning on simulator. Reduce the power supply voltage to 3.5Vdc and check the power on light changes to yellow and flashes to indicate low battery and that an audible beep sounds every 30 sec ±5 sec. Increase power supply voltage to 4.5Vdc and check power on light changes to green and is permanently lit and battery low audible beeping stops. Turn off the unit, disconnect the power supply and replace battery compartment cover.

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Service Manual – RM15

Appendix B Alternative Test Procedure Procedure does not require the use of a Respiration Simulator. Check the unit has no sign of any damage. Fit batteries. Power up the unit and check the power on/off light illuminates green. Press Power button for 1 second and release. Ensure the unit doesn’t turn off. Press Power button for 3 seconds and release. Ensure the unit turns off. Power up the unit again. Set delay to 10, 15 and 20 sec in turn and check correct lights illuminate, yellow. Power down and up again and check delay is still set to 20 sec (last setting). Set delay to 10 sec. Power down and up again and check delay is still set to 10 sec (last setting). Attach a respiration sensor. Tap sensor approximately once every 2 seconds, check respiration click sounds and green light illuminates for each tap. Press respiration sounder on/off button, check associated light illuminates yellow and click stops. Press respiration sounder on/off button and check associated light extinguishes and click re-starts. Stop tapping sensor and check audible and visual alarm (3 red lights) start after 10 sec ±2 sec. Tap sensor twice (only) and check alarm continues. Tap sensor three times and check alarm sounder stops and lights continue to flash. Stop tapping sensor and check audible alarm sounds after 10 sec ±2 sec. Press Alarm Cancel and check audible and visual alarm stops and re-starts after 1 minute ±5 sec. Press Alarm Cancel, start tapping sensor again, check alarm does not recur after 1 minute ±5 sec. Change delay to 15 sec. Stop tapping sensor and check audible and visual alarm starts after 15 sec ±2 sec. Press Alarm Cancel and start tapping sensor again. Change delay to 20 sec. Stop tapping sensor and check audible and visual alarm starts after 20 sec ±2 sec. Press Alarm Cancel and start tapping sensor again. Set Delay to 10 sec. Turn off the unit. Remove batteries and attach a variable power supply to the battery terminals. Set output voltage of power supply to 4.5Vdc and turn it on. Turn on the apnoea monitor and check it is functioning by tapping sensor. Reduce the power supply voltage to 3.5Vdc and check the power on light changes to yellow and flashes to indicate low battery and that an audible beep sounds every 30 sec ±5 sec. Increase power supply voltage to 4.5Vdc and check power on light changes to green and is permanently lit and battery low audible beeping stops. Turn off the unit, disconnect the power supply and replace battery compartment cover.

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