SLE1500 OxyGenie Instructions for Use Sw V4 Issue 6

SLE1500 Instructions for Use

WARNING: A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

SLE Ltd Commerce Park Commerce Way, Croydon CR0 4YL, United Kingdom

CAUTION: A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, could result in minor or moderate injury. NOTE: Emphasises information of importance. This manual is only to be used with the SLE1500.

Telephone: +44 (0)330 175 0000

OxyGenie® is a registered trademark in the EEA. Masimo, Blue, DCI, E1, LNCS, LNOP, SET, TF-I, ROS, DOS, and uSpO2 are registered trademarks of Masimo Corporation. M-LNCS, RD SET, LNOPv, and TFA-1 are trademarks of Masimo Corporation.

E-mail: [email protected]

Website: www.inspirationhealthcaregroup.com

All other marks used are the property of their respective proprietors. SLE Ltd may revise or replace this manual without notice. Please contact your sales provider to ensure you have the most recent revision. All rights reserved. No part of this publication may be reproduced, stored in any retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopy, recording or otherwise, without the prior permission of SLE.

Distributor

© Copyright SLE 25/10/2023 Document ref: RA-IFU-000020 Issue 6 UM179/UK

2

SLE1500 Instructions for Use 8.13. Locking/unlocking the screen ... 37 8.14. Switching off the SLE1500 ... 37

Contents 1. Intended use ... 5

9. Alarms ... 38

1.1. Operating principle ... 5 1.2. OxyGenie®... 6

9.1. Adaptive alarms... 38 9.2. Technical alarms ... 38 9.3. Low priority alarms ... 40 9.3.1. General low priority alarms... 40 9.3.2. Masimo SpO2 low priority alarms ... 42 9.3.3. Masimo SpO2 low prioritytext messages.. 43 9.4. Medium priority alarms ... 44 9.4.1. General medium priority alarms ... 44 9.4.2. Masimo SpO2 limit medium priority alarms ... 45 9.5. High priority alarms ... 46 9.6. Alarm information screen ... 48 9.7. Alarm pre-mute... 48 9.8. Unrecoverable fault screen ... 48

2. Intended user ... 6 3. Operational notes ... 6 4. Limitations of use ... 6 5. Accessories ... 7 5.1. Included accessories... 7 5.2. Optional accessories... 8 5.3. Accessories for patient monitoring ... 8 5.4. High Flow mode accessories ... 10 5.5. Manual mode accessories ... 11 5.6. Intersurgical accessories... 12 5.7. Support documentation ... 13 6. Warnings and Cautions ... 14 6.1. SLE1500 warnings and cautions... 14 6.2. Masimo SpO2 warnings and cautions ... 15 6.3. OxyGenie® warnings and cautions... 17

10. Patient Monitoring ... 49

7. SLE1500 Assembly schematic ... 18

10.1. Overview ... 49 10.2. Set-up... 49 10.3. Patient Monitoring Display Information... 50

7.1. Installation ... 18

11. Settings ... 52

8. User interface ... 20

11.1. Adjusting screen brightness ... 53 11.2. Selecting language... 53 11.3. Selecting graph preferences ... 54 11.4. Protected settings... 55 11.4.1. Calibration menu ... 55 11.4.2. Adjusting time and date screen ... 56 11.4.3. Alarm history screen... 56 11.4.4. Software version number ... 56

8.1. SLE1500 start-up ... 20 8.2. Therapy screen ... 21 8.3. Therapy mode selection... 21 8.4. Therapy Modes ... 22 8.4.1. Neonatal, infant and paediatric HFOT Mode ... 22 8.4.2. Neonatal, infant and paediatric nCPAP – Flow Mode... 22 8.4.3. Neonatal, infant and paediatric nCPAP – Pressure Mode... 22 8.4.4. Manual Flow Mode... 23 8.4.5. Settings Mode ... 23 8.5. Therapy parameter adjustment ... 24 8.6. Start/pause treatment... 24 8.7. Therapy graph display... 25 8.8. SpO2 display ... 27 8.8.1. SpO2 settings and alarm limits... 28 8.9. OxyGenie®... 30 8.10. OxyGenie® modes of operation... 31 8.10.1. Treatment screens ... 32 8.10.2. Graph preferences ... 33 8.10.3. Manual override ... 33 8.10.4. SpO2 Settings with OxyGenie® ... 34 8.10.5. SpO2 Alarm Limits with OxyGenie®... 34 8.10.6. Fall-back Mode... 35 8.10.7. Turning off OxyGenie® ... 35 8.11. Power status display ... 36 8.12. Alarm display... 36

12. Symbols ... 57 13. Maintenance ... 61 13.1. Visual inspection ... 61 13.2. Periodic maintenance... 61 13.3. Servicing... 61 14. Cleaning ... 61 14.1. Cleaning instructions ... 61 14.2. Disinfection... 61 15. Duration of use ... 62 16. Disposal ... 62 16.1. WEEE Compliance ... 62 17. Storage, transport and operating conditions ... 62 17.1. Storage and transport conditions ... 62 17.2. Operating conditions ... 62

3

SLE1500 Instructions for Use 18. Technical & performance data ... 63 18.1. Technical... 63 18.1.1. Size ... 63 18.1.2. Weight ... 63 18.1.3. Gas supply (STPD) ... 63 18.1.4. Performance (BTPS)... 63 18.1.5. Mechanical PRV... 63 18.1.6. OxyGenie® PCLCS attributes... 63 18.1.7. Electrical rating... 63 18.1.8. Battery... 63 18.1.9. SD Card ... 63 18.1.10. System connections ... 63 18.1.11. Alarm volume ... 63 18.1.12. Noise emissions ... 63 18.2. Measurements ... 64 18.2.1. O2 ... 64 18.2.2. Flow... 64 18.2.3. Outlet Pressure ... 64 18.2.4. Patient Pressure... 64 18.2.5. SpO2 ... 64 18.2.6. Pulse ... 64 18.2.7. PI (Perfusion index)... 64 18.3. Classifications ... 65 19. Regulatory ... 65 19.1. Product standards ... 65 19.2. Essential Performance ... 65 20. EMC Compliance ... 66 20.1. Emissions tests compliance levels... 66 20.2. Immunity tests compliance levels... 66 21. Warranty ... 67 22. Pulse Oximetry–Masimo SET® ... 68 22.1. Principles of Operation... 68 22.2. Product Description... 68 22.3. Method of Operation ... 68 22.4. SpO2 Product Specifications... 68 22.5. Sensor accuracy information... 69 22.6. Masimo Patent Information ... 70 22.7. No Implied Licence Statement ... 70 22.8. Nomogram for CPAP and Flow... 70

4

SLE1500 Instructions for Use

1. Intended use

The SLE1500 monitors the O2%, flow rate and pressure of the gas delivered to the patient. The monitored parameters are displayed numerically on the therapy screen and can also be displayed graphically via a configurable real-time waveform.

The SLE1500 is intended to drive an air/oxygen blend at controlled flow and pressure to the required device for the chosen therapy. The SLE1500 is intended for use with neonatal, infant and paediatric patients.

In neonatal nCPAP mode the therapy screen will display a calculated breaths per minute value. The breaths per minute calculation uses a Schmitt trigger, which adjusts its threshold values, based on an average patient pressure. The mid-point average is calculated from 100 samples, so has a response time of 0.53s. The upper and lower thresholds are defined as 8% either side of the average patient pressure. Each time the patient pressure (85ms response time) crosses these thresholds, the time is noted. The reciprocal of this time gives the breaths per minute value.

The integrated Masimo SET® Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Pulse Oximeter is indicated for use with neonatal, infant and paediatric patients during both motion and no-motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The SLE1500 is supplied with an internal thermal mass flow sensor and a paramagnetic oxygen sensor. Both sensors are maintenance free and intended to last the lifetime of the device. The sensors are calibrated using the in-built calibration function within the device settings. The patient respiratory pressure is measured via the 6% female Luer proximal pressure port on the front of the device and/or the internal pressure sensor in the respiratory gas outlet.

The incorporated OxyGenie® system is intended to control the inspired oxygen delivery, to keep the SpO2 of the patient within a predefined range of SpO2, during mechanical ventilation, nCPAP and non-invasive respiratory support administered to neonatal, infant and paediatric patients.

1.1

Operating principle

The SLE1500 will deliver a continuous flow of blended oxygen and medical air in order to provide respiratory support for spontaneously breathing patients.

The SLE1500 contains a number of audible and visual text alarms to help ensure patient safety. A log of alarm incidents is saved to an internal memory.

The SLE1500 is intended to run on mains power and with high-pressure oxygen and air from wall supplies or cylinders.

The SLE1500 contains a rechargeable Li-ion battery, intended to provide limited backup power in the event of mains failure.

The SLE1500 offers a range of therapy modes. The parameter settings and alarms in these modes are customised to the intended patient size and therapy type. A full description of the therapy modes is included later in the Instructions for Use.

The Masimo SET® SpO2 sensor can be connected to the device to continuously monitor the patient’s blood oxygen saturation and pulse. The patient’s perfusion index and real-time plethysmograph waveform can also be displayed.

The SLE1500 contains an internal memory and, on device restart, will revert to the last used mode and reset to the lowest parameter settings for that mode.

See “Pulse Oximetry–Masimo SET®” on page 68 for more details.

The SLE1500 does not contact the patient but the user interacts with the device during set up.

In the event of a mains failure, the battery backup will continue to power the device with no change to the pulse oximeter equipment. Once the battery backup has run out, the device will turn off.

The user interface and therapy display are navigated using the 4.2” colour touchscreen. A separate power on/off button is located below the touchscreen.

NOTE: Leaks or internal venting of sample gas will have no effect on performance. If a leak is significant, the device will alarm or compensate.

The button will illuminate green when the device is switched on.

5

SLE1500 Instructions for Use

1.2

4. Limitations of use

OxyGenie®

The OxyGenie® system is integrated into the SLE1500 and is intended to control the inspired oxygen delivery, to keep the SpO2 of the patient within a predefined range of SpO2, during nCPAP, non-invasive respiratory support and High Flow Oxygen Therapy administered to neonatal, infant and paediatric patients. The OxyGenie® algorithm is a closed loop proportional-integral-derivative (PID) controller. Once a second, this algorithm uses the patient’s SpO2 (measured using Masimo SET® sensors) to calculate the appropriate O2 setting to maintain SpO2 within a target range.

• Not for use in homecare environment. • Not for use in a hyperbaric chamber. • The materials used in the SLE1500 and related equipment may not be compatible with anaesthetic or respirable gases, solutions/suspensions/emulsions that have not been evaluated. • Not for use with helium or gas mixtures including helium. • Not for use with antistatic or electrically conductive hoses or tubing. • Use of OxyGenie® is contraindicated on cardiac patients.

• Not for use during magnetic resonance imaging

WARNING: Use of OxyGenie® is contraindicated on patients whose target SpO2 is outside the available pre-set target ranges.

(MRI) or in an MRI environment.

WARNING: Use of OxyGenie® is contraindicated on cardiac patients.

2. Intended user To be used by clinical staff with an appropriate level of training in a hospital environment.

3. Operational notes • For use in hospital and hospital-type facilities only. • For use with spontaneously breathing patients only. • Only for use with tubing and breathing sets compliant with ISO 5367:2000. • Only for use with respiratory humidifiers compliant with ISO 8185:2007 or ISO 80601-2-74: 2020. • For use with SLE-recommended breathing system and accessories only. • Only for use with the supplied power supply. • For use with medical air and/or medical oxygen only. • Intended for use with the operator positioned directly in front of the device and with the display in full view. WARNING: Use of non-SLE recommended accessories or consumables could cause device malfunction, breakage or patient injury.

6

SLE1500 Instructions for Use

5. Accessories 5.1

Included accessories Items

Image

Part No

SLE1500 Plug top power supply - 3m Operating Voltage: 80 to 275 VAC, 47 to 63 Hz Max Power: 16.5W • Double insulated, Class II Protection • IEC60601-1 Edition 3.1, • ES60601-1:2005(R2012), • CSAC22.2 NO.60601-1:14, • EN60601-1:2006/A1:2013

MBL2411

SLE1500 Desktop power supply - 3m Operating Voltage: 80 to 275 VAC, 47 to 63 Hz Max Power: 13W Class I Protection • IEC60601-1 Edition 3.1, • ES60601-1:2005(R2012), • CSAC22.2 NO.60601-1:14, • EN60601-1:2006/A1:2013

MBL2711

Masimo RD SET® MD14-05 patient cable REF: RD SET MD14-05 (contact Masimo for sales and support)

Masimo SET® LNC- 4 patient cable REF: LNC SET (contact Masimo for sales and support)

7

MBL2432B00

LNC-4

SLE1500 Instructions for Use

5.2

Optional accessories Items

Image

Part No

F&P Medi-rail mounting bracket

N6627/08

Fixed pole clamp

7601000

Trolley

N6695

5.3

Accessories for patient monitoring

For use with both Philips IntelliBridge Items

Image

SLE1500 patient monitoring cable D-SUB 9 to mini-jack (Order from SLE)

DCI Masimo RD SET® DCI adult reusable sensor (For test purposes)

Part No

NBL9033

MBL2432C00

Masimo RD SET® Inf

4002

8

SLE1500 Instructions for Use

For use with both Philips IntelliBridge Items

Image

Part No

Masimo RD SET® Neo

4003

Masimo RD SET® NeoPt

4004

Masimo RD SET® NeoPt-500

4005

9

SLE1500 Instructions for Use

5.4

High Flow mode accessories

IntelliBridge Components Items

Image

Philips Part No

Philips IntelliBridge EC10 Module

865115 #A01,101

IntelliBridge EC5 ID-Module

865114 #101DB9 male connector

1.5 m: 865114 #L21 3 m: 865114 #L02 10 m: 865114 #L03

Standard ethernet cable, CAT5, straight wired

All accessories for patient monitoring are to be ordered from Philips; apart from SLE1500 patient monitoring lead. • See section 10 of this User Manual for set-up and further information on patient monitoring with the SLE1500. • For information on the full range of Philips IntelliBridge options available, please contact Philips for sales support. • SLE assumes no liability for correctness of stated Philips Product Codes.

Interface Description

Breathing Circuit and Interface Product Code

Fisher and Paykel Optiflow Ventilator Circuit

RT331

Fisher and Paykel Optiflow Junior Premature Nasal Cannula

OPT312

Fisher and Paykel Optiflow Junior 2 Nasal Interface XS

OJR410

Fisher and Paykel Optiflow Junior 2 Nasal Interface S

OJR412

Fisher and Paykel Optiflow Junior 2 Nasal Interface M

OJR414

Fisher and Paykel Optiflow Junior 2 Nasal Interface L

OJR416

Fisher and Paykel Optiflow Junior 2 Nasal Interface XL

OJR418

10

SLE1500 Instructions for Use

Humidification Description* Fisher and Paykel MR290 Humidification Autofeed Chamber

Humidification Chamber Product Code N3290/01

*NOTE: Any standard CE marked electronic humidifiers that are suitable and designed for use with infants and neonates shall be used with SLE1500.

5.5

Manual mode accessories* Interface Description

Fisher and Paykel Bubble CPAP System with FlexiTrunk Interface

Breathing Circuit and Interface Product Code BC161-10

Fisher and Paykel Nasal Tubing 70 mm

BC191

Fisher and Paykel Nasal Prongs (3.0mm nare diameter/2.0mm septal width)

BC3020

Fisher and Paykel Nasal Prongs (3.5mm nare diameter/2.0mm septal width)

BC3520

Fisher and Paykel Nasal Prongs (4.0mm nare diameter/3.0mm septal width)

BC4030

Fisher and Paykel Nasal Prongs (4.5mm nare diameter/4.0mm septal width)

BC4540

Fisher and Paykel Nasal Prongs (5.0mm nare diameter/4.0mm septal width)

BC5040

Fisher and Paykel Nasal Prongs (5.0mm nare diameter/5.0mm septal width)

BC5050

Fisher and Paykel Nasal Prongs (5.5mm nare diameter/5.0mm septal width)

BC5550

Fisher and Paykel Nasal Prongs (5.5mm nare diameter/6.0mm septal width)

BC5560

Fisher and Paykel Nasal Prongs (6.0mm nare diameter/6.0mm septal width)

BC6060

Fisher and Paykel Nasal Prongs (6.0mm nare diameter/7.0mm septal width)

BC6070

Fisher and Paykel Nasal Prongs (6.5mm nare diameter/7.0mm septal width)

BC6570

Fisher and Paykel Infant Nasal Mask – Small

BC800

Fisher and Paykel Infant Nasal Mask – Medium

BC801

Fisher and Paykel Infant Nasal Mask – Large

BC802

Fisher and Paykel Infant Nasal Mask – Extra Large

BC803

*NOTE: Non SLE stock, contact F&P for purchase.

11

SLE1500 Instructions for Use

5.6

Intersurgical accessories* Interface Description Circuit

nFlow™ CosyFit infant CPAP heated wire breathing system with detachable monitoring line ≥ 1.8m

Interface Description

Breathing Circuit and Interface Product Code 4800016

Modular System Product Code

Modular System nFlow™ CosyFit Generator Adapter Kit with Nasal Prongs

Interface Description

4800004

Bonnet Product Code

Bonnets nFlow™ CosyFit, Infant Bonnet, navy, size 9 (40 - 42 cm)

4907009

nFlow™ CosyFit, Infant Bonnet, turquoise, size 8 (38 - 40 cm)

4907008

nFlow™ CosyFit, Infant Bonnet, orange, size 7 (36 - 38 cm)

4907007

nFlow™ CosyFit, Infant Bonnet, red, size 6 (34 - 36 cm)

4907006

nFlow™ CosyFit, Infant Bonnet, green, size 5 (32 - 34 cm)

4907005

nFlow™ CosyFit, Infant Bonnet, light orange, size 4 (30 - 32 cm)

4907004

nFlow™ CosyFit, Infant Bonnet, blue, size 3 (28 - 30 cm)

4907003

nFlow™ CosyFit, Infant Bonnet, yellow, size 2 (26 - 28 cm)

4907002

nFlow™ CosyFit, Infant Bonnet, dark grey, size 1 (24 - 26 cm)

4907001

nFlow™ CosyFit, Infant Bonnet, pink, size 0 (22 - 24 cm)

4907110

nFlow™ CosyFit, Infant Bonnet, grey, size 00 (20 - 22 cm)

4907100

nFlow™ CosyFit, Infant Bonnet, white, size 000 (18 - 20 cm)

4907000

Interface Description

Mask and Prongs Product Code

Mask and Prongs nFlow™ Nasal Mask, Extra Large

4716000

nFlow™ Nasal Mask, Large

4706000

nFlow™ Nasal Mask, Medium

4705000

nFlow™ Nasal Mask, Small

4704000

nFlow™ Nasal Prong, Large

4703000

nFlow™ Nasal Prong, Medium

4702000

12

SLE1500 Instructions for Use

Interface Description

Mask and Prongs Product Code

Mask and Prongs nFlow™ Nasal Prong, Small

4701000

nFlow™ Nasal Prong, Extra Small

4711000

5.7

Support documentation

TS-SVM-000002 - SLE1500 Service Manual – English RA-IFU-000031 - SLE1500 Quick Start Guide – English Please contact SLE for further information and advice - [email protected]

13

SLE1500 Instructions for Use

6. Warnings and Cautions 6.1

• Do not occlude or tamper with any of the SLE1500 ports. • Ensure red dust caps are removed from device prior to use. • Do not reuse single-use accessories. Reuse poses a threat to patient safety in terms of cross infection and device malfunction and breakage. Cleaning can lead to device malfunction and breakage. • Ensure SLE1500 display screen is visible at all times. • The SLE1500 is a high flow device and should only be connected to a pipeline installation that allows for the indicated flow. • Should device software malfunction, display an unrecoverable error screen, or perform any unexpected action, remove from service and contact SLE for technical support. • Output cannot exceed the concentration of the input. • No alarms are present to indicate patient disconnection in flow mode using nFlow™ Generator with extra small prongs and small prongs. • For low set pressure (up to 4 mbar), the only alarm to state leak may be the “Unexpected flow high” with: nFlow™ Generator with extra small prongs.

SLE1500 warnings and cautions

WARNINGS: • Operators should familiarise themselves with this manual before using the SLE1500 on a patient. • The functioning of this device may be adversely affected by the operation of equipment such as high frequency surgical (diathermy) equipment, defibrillators, mobile phones or short-wave therapy equipment. If this occurs, the SLE1500 should be removed from the vicinity of such devices. Ensure normal operation of devices prior to use. • Do not use the SLE1500 in the presence of flammable anaesthetic agents or other ignition sources. • Unauthorised modification of the SLE1500 is not to be carried out by the end user. • Visually inspect the SLE1500 and accessories for damage before use. • Every component of the breathing system must be visually inspected and checked for function, leakage and occlusions, immediately before use on each patient. Ensure that connections are secure. • Check the condition of the gas supply hoses to the SLE1500. Do not use any hose that shows signs of cracking, abrasion, kinking, splits, excessive wear or ageing. Make sure that the Air and O2 hose have not come into contact with oil or grease. • Do not use the SLE1500 if it is subjected to a significant force or impact. Remove the SLE1500 from use and contact SLE for technical assistance. • Prior to use, consult the respective documentation and Instructions for Use of all connected devices, or combination of devices. • The materials used in the SLE1500 and related equipment may not be compatible with anaesthetic or respirable gases, solutions/ suspensions/emulsions that have not been evaluated. • If an alarm condition cannot be identified, the SLE1500 should be turned off immediately and removed from service. • Monitor the clinical parameters of the patient during the treatment. The device alarms should not be the only method of detecting faults. • Flow accuracy can be affected by use of a gasdriven nebuliser. • On activation of an adaptive alarm, check supply of gas to the patient. • Only to be used by suitably qualified clinicians. • Check the SLE1500 settings and alarm status before starting and during treatment.

CAUTIONS: • When connecting or disconnecting the breathing system, use a push and twist action. • Mount the SLE1500 in an upright orientation. • Ensure that screen touches are correctly registered. • Ensure that gas supply is connected prior to starting treatment. Do not connect gas supply if treatment is already running without pausing the treatment first. • If the SLE1500 is operating on battery power and is allowed to completely discharge the battery, the unit should be recharged as soon as possible. This is to avoid damaging the batteries by allowing them to remain in a deep discharged state for any period of time. Allowing the batteries to remain in the deep discharged state will shorten the life of the batteries and the amount of time the SLE1500 can remain on battery power. • The SLE1500 contains temperature dependent devices which perform normally in controlled environments in hospitals. If the SLE1500 has been stored at a temperature different to that in which it will be used, allow the unit to acclimatise before powering up. • The SLE1500 requires calibration after every software update.

14

SLE1500 Instructions for Use

6.2

Masimo SpO2 warnings and cautions

• Inaccurate SpO2 readings may be caused by:

NOTE: These cautions and warnings refer to use of Masimo Pulse Oximetry. GENERAL: • The pulse oximeter is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, directions for use, all precautionary information, and specifications should be read before use. WARNINGS: • As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. • Do not place the pulse oximeter or accessories in any position that might cause it to fall on the patient. • Do not start or operate the pulse oximeter unless the set-up was verified to be correct. • Do not use the pulse oximeter during magnetic resonance imaging (MRI) or in an MRI environment. • Do not use the pulse oximeter if it appears or is suspected to be damaged. • Explosion hazard: Do not use the pulse oximeter in the presence of flammable anaesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. • To ensure safety, avoid stacking multiple devices or placing anything on the device during operation. • To protect against injury, follow the directions below: ○ Avoid placing the device on surfaces with visible liquid spills. ○ Do not soak or immerse the device in liquids. ○ Do not attempt to sterilise the device. ○ Use cleaning solutions only as instructed in this operator's manual. ○ Do not attempt to clean the device while monitoring a patient. ○ To protect from electric shock, always remove the sensor and completely disconnect the pulse oximeter before bathing the patient. ○ If any measurement seems questionable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning.

•

•

• •

•

• •

•

15

○ Improper sensor application and placement. ○ Elevated levels of COHb or MetHb: High levels of COHb or MetHb may occur with a seemingly normal SpO2. When elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) of a blood sample should be performed. ○ Elevated levels of bilirubin. ○ Elevated levels of dyshemoglobin. ○ Vasospastic disease, such as Raynaud’s, and peripheral vascular disease. ○ Hemoglobinopathies and synthesis disorders such as thalassemia, Hb s, Hb c, sickle cell, etc. ○ Hypocapnic or hypercapnic conditions. ○ Severe anaemia. ○ Very low arterial perfusion. ○ Extreme motion artefact. ○ Abnormal venous pulsation or venous constriction. ○ Severe vasoconstriction or hypothermia. ○ Arterial catheters and intra-aortic balloon. ○ Intravascular dyes, such as indocyanine green or methylene blue. ○ Externally applied colouring and texture, such as nail polish, acrylic nails, glitter, etc. ○ Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers, etc. ○ Skin colour disorders. Interfering substances: Dyes or any substance containing dyes that change usual blood pigmentation may cause erroneous readings. The pulse oximeter should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptoms. The pulse oximeter is not an apnoea monitor. The pulse oximeter may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements. The pulse oximeter may be used during electrocautery, but this may affect the accuracy or availability of the parameters and measurements. The pulse oximeter should not be used for arrhythmia analysis. SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methaemoglobin (MetHb). Do not adjust, repair, open, disassemble, or modify the pulse oximeter or accessories. Injury to personnel or equipment damage could occur. Return the pulse oximeter for servicing if necessary.

SLE1500 Instructions for Use limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 metre or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. • Disposal of product - Comply with local laws in the disposal of the device and/or its accessories. • To minimize radio interference, other electrical equipment that emits radio frequency transmissions should not be in close proximity to the pulse oximeter. • Replace the cable or sensor when a Replace Sensor or when a Low SIQ message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual.

• Misapplication of a pulse oximeter sensor with excessive pressure for prolonged periods can induce pressure injury. CAUTIONS: • Do not place the pulse oximeter where the controls can be changed by the patient. • Electrical shock and flammability hazard: Before cleaning, always turn off the device and disconnect from any power source. • When patients are undergoing photodynamic therapy, they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimise interference with photodynamic therapy. • Do not place the pulse oximeter on electrical equipment that may affect the device, preventing it from working properly. • If SpO2 values indicate hypoxemia, a laboratory blood sample should be taken to confirm the patient’s condition. • If the Low Perfusion message is frequently displayed, find a better perfused monitoring site. In the interim, assess the patient and, if indicated, verify oxygenation status through other means. • Change the application site or replace the sensor and/or patient cable when a “Replace sensor” and/or “Replace patient cable”, or a persistent poor signal quality message (such as “Low SIQ”) is displayed on the host monitor. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor. • If using pulse oximetry during full body irradiation, keep the sensor out of the radiation field. If the sensor is exposed to the radiation, the reading might be inaccurate, or the device might read zero for the duration of the active irradiation period. • To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time the pulse oximeter is used. • Variation in measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patient’s clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analysed by laboratory instruments prior to clinical decision making to completely understand the patient’s condition. • Do not submerge the pulse oximeter in any cleaning solution or attempt to sterilise by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the pulse oximeter. • Electrical Shock Hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable

NOTES: • A functional tester cannot be used to assess the accuracy of the pulse oximeter. • High-intensity extreme lights (such as pulsating strobe lights) directed on the sensor, may not allow the pulse oximeter to obtain vital sign readings. • When using the Maximum Sensitivity setting, performance of the "Sensor Off" detection may be compromised. If the device is in this setting and the sensor becomes dislodged from the patient, the potential for false readings may occur due to environmental "noise" such as light, vibration, and excessive air movement. • Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the patient cabling. • Additional information specific to the Masimo sensors compatible with the pulse oximeter, including information about parameter/ measurement performance during motion and low perfusion, may be found in the sensor's Directions for Use (DFU). • Cables and sensors are provided with X-Cal™ technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time.

16

SLE1500 Instructions for Use

6.3

OxyGenie® warnings and cautions

NOTES: These cautions and warnings refer to use of OxyGenie®. The “Reference O2” value is an average of the patient’s oxygen requirement for every 30 minutes. OxyGenie® is only available when the SpO2 sensor is connected and SpO2 monitoring is turned on. GENERAL: • OxyGenie® is to be operated by, or under the supervision of, qualified personnel only. The manual, accessories, Directions for Use, all precautionary information, and specifications should be read before use. • Before initiating (or reinitiating) OxyGenie®, check that the O2 setting reflects the patient’s current clinical condition to ensure that the control algorithm responds appropriately. Failure to do so can affect the response time of the algorithm. WARNINGS: • SpO2 monitoring is via Masimo sensor. High and low SpO2 alarms are automatically set to 1% above the upper end of the target range and 1% below the lower end of the target range. These limits are user adjustable. • See SLE SpO2 Pulse Oximetry Cable (Masimo SET®) IFU for details of conditions which may affect the accuracy of SpO2 readings. • Do not use OxyGenie® if the difference between SpO2 and SaO2 is greater than 5%. • Time base for the OxyGenie® graph is selectable by the user between 10, 30, 60 & 120 minutes, graph axis displays duration of time. • The boost function (+5%) is not recommended to be used when the set O2 is equal or higher than 60, since it may not provide the desired oxygen output. CAUTIONS: • Additional ventilator independent patient monitoring (bedside vital-monitoring blood-gas analyser) should be performed. • An increasing requirement for oxygen while using OxyGenie® may be indicative of an underlying condition which has to be addressed, even if SpO2 is within the target range.

17

SLE1500 Instructions for Use

7. SLE1500 Assembly schematic

7.1

Installation

• Remove and dispose of the red dust caps from the device prior to first use.

Mount the SLE1500 • Attach the mounting bracket to the medi-rail, drip pole, trolley or other secure location. • Mount the SLE1500 on to the bracket. WARNING: Ensure that the SLE1500 is mounted securely to the bracket before the gas supplies, power supply, sensor cable or breathing system are connected. Connect supply • Connect the air supply to the SLE1500, ensure the supply is between 2 and 6 bar. • Connect the O2 supply to the SLE1500, ensure the supply is between 2 and 6 bar. • Connect the power supply to the SLE1500 and ensure the plug is safely connected to the mains. WARNING: Ensure that gas supply connections are hand tightened to avoid damage to the SLE1500. Do not use a spanner. Calibrate • Calibrate the SLE1500 prior to first use. See the service manual for further details.

18

SLE1500 Instructions for Use Connect the breathing system • Connect the breathing circuit to the SLE1500 respiratory gas outlet (see breathing system IFU for details). • Connect the breathing circuit proximal gas monitoring line to the proximal pressure port using a push and twist action (if applicable see breathing system IFU for details). Connect the SpO2 sensor (optional) • Connect the SpO2 sensor to the SpO2 connection on the SLE1500 (see SpO2 sensor IFU for details). WARNING: Ensure the following checks are performed before first use (refer to the SLE1500 service manual for further details): • Electrical safety check • Flow calibration • O2 calibration • Functionality checks WARNING: Ensure that pre-use checks are carried out on both the SLE1500, breathing system and other accessories prior to each use. WARNING: If a malfunction is detected, do not use the SLE1500 and contact SLE for assistance.

7.2 Using device with SLE1500 Cart • The SLE1500 is verified for use with the recommended SLE Cart. • The SLE1500 Cart is provided with an extendable pole with 4 bag holders, adjustable upper and lower mounting brackets and an accessories basket. • The SLE Cart should be adjusted for maximum stability. Limit the height of the bag holders to the minimum required for water to flow unimpeded up to a maximum of 1.8 metres/ 6 feet. • Use a maximum of 2kg (1 x 2 litre or 2 x 1 litre) water bags on the holders.

19

SLE1500 Instructions for Use

8. User interface 8.1

• If the Low Power screen is displayed, the SLE1500 will turn off after 5 seconds. • Check the SLE1500 is connected to mains power and press and hold the power on/off button. • If the power splash screen is still displayed, remove the SLE1500 and contact SLE for assistance. • If a malfunction is detected, the following message is displayed:

SLE1500 start-up

• To switch on the SLE1500, press and hold the power on/off button.

• A ‘splash screen’ will be displayed. • A system test is initiated automatically, and the SLE1500 alarms will beep twice. • During the system test the performance of the following components are checked: Software

WARNING: If a malfunction is detected or the device does not beep twice, remove the SLE1500 from use and contact SLE for assistance.

Electronic controls Audible alarms Power supply NOTE: The SLE1500 contains a rechargeable Liion battery intended to provide limited backup power in the event of mains failure. The battery is intended for short-term use only. The SLE1500 functionality may be limited when running on backup power. The SLE1500 should be plugged into the mains for as long as possible. The SLE1500 should be checked, calibrated and serviced before putting back into operation if it has been in storage for over 6 months. • If the power detected is too low to start the SLE1500, the Low Power splash screen will be displayed.

Low Power splash screen

20