Inditherm

Inditherm AlphaCore5 Instructions for Use Rev 8 Oct 2018

Instructions for Use

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Patient Warming System Instructions for Use

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Contents 1.

Introduction General Description Description of Parts

3 3 3

Symbols

Safety Intended Use Indication for Use Contraindications Warnings Disclaimers User Profile

8 8 8 8 8 10 10

System Description/Application AlphaCore5 Controller Mattresses and Blanket

10 10 11

Connection and Disconnection Power to the AlphaCore5 Controller Power from the AlphaCore5 Controller ODU Connector Amphenol Connector Patient Probe

12 12 12 12 13 13

AlphaCore5 Controller Start-up AlphaCore5 Controller Start-up Cycle Bootloader Screen Bootloader HIGH PRIORITY ALARM Test Bootloader MEDIUM PRIORITY ALARM Test Bootloader LOW PRIORITY ALARM Test Commence Normal Operation

14 14 14 14 14 14 15

System Setup Control Descriptions Settings Screen (with active choices in green) Clock and Calendar Adjustment Screens Clock Adjustment Screens Calendar Adjustment Screens How to Use the AlphaCore5 Controller User Selectable Options Checking the Clock

16 16 16 17 17 17 18 21 22

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Normal Operation

Checking of Thermal Cut-Out Monthly Thermal Cut-Out Test Notification Thermal Cut-Out Test Access Settings Menu Select Thermal Cut-Out Test Thermal Cut-Out Test Screen Thermal Cut-Out Detected Thermal Cut-Out Not Detected

23 23 23 23 24 24 25 25

10. Checking of Alarms Temperature Sensor Alarm Test Access Settings Menu Select Temperature Sensor Alarm Test Temperature Sensor Alarm Test (ALARM-3-TEMP-HIGH) Temperature Sensor Alarm Test (ALARM-2-ACCESSORY-THERM) Temperature Sensor Alarm Test (ALARM-2-ACCESSORY-CUT-OUT)

26 26 26 26 27

11. Storage

12. Infection Control and Cleaning

13. Service & Maintenance

14. Disposal

15. Problem Solving and Warning Messages

16. Power Status Indicators

17. Alarms, User Alerts and User Actions

18. Technical Description and Specification

28 29

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Patient Warming System Instructions for Use

Patient Warming System 1. Introduction General Description The Inspiration Healthcare Limited Patient Warming System is designed for use in the operating room, recovery room, anaesthetic room, intensive care and emergency department. The AlphaCore5 Controller has only one mode of operation, providing safe and controlled warming to assist patients in maintaining normal body temperature. The applied parts are available as: • Mattresses for use under a patient • Blanket to be placed over a patient • Patient probe to indicate patient temperature (provided by third party manufacturer) Mattresses and blanket can be used in combination with each other simultaneously providing the total power draw of the combination does not exceed that required by two IHC-OTM1 mattresses (maximum total loading 170 watts). The patient’s core temperature should be regularly and independently monitored.

Different sizes and models of mattress and blanket are available from Inspiration Healthcare Limited for various procedures and situations. The AlphaCore5 Controller powers the mattresses and blanket at low voltage, ensuring safety for patients and operators. The temperature is controlled automatically to an operator selected level. An overtemperature safety cut-out is integrated into each mattress and blanket. The AlphaCore5 Controller is provided with a multi-purpose clamp and can be placed on a flat surface or mounted on an Intravenus pole (IV pole), anaesthetic machine, or Medi-rail. The system can control up to 5 accessory mattresses and/or blanket for one patient. It has a range of operating temperatures from 25-40°C and is designed to be operated continuously, maintaining a uniform heat under and/or over the patient. The serviceable life of the AlphaCore5 Controller is 5 years and serviceable life of the mattresses, blanket and connecting cables is 3 years under normal use conditions.

Description of Parts Figure 1 shown below is a picture of the AlphaCore5 Controller with mattresses and blanket.

Figure 1 – AlphaCore5 Controller with mattresses and blanket

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AlphaCore5 Controller Part Number

Part Description

IHC-1000

AlphaCore5 Controller

Note: Max Watts per channel = 85W, Sum of all channels Max Watts = 170W Table 1 - AlphaCore5 Controller Details

Operating Theatre Mattress Part Number

Part Description

Wattage

Warming Up Time

IHC-OTM1

O.T. Mattress, Full Length (1900mm x 585mm)

77W

45 minutes

IHC-OTM1-N

O.T. Mattress, Full Length, Narrow (1900mm x 535mm) 77W

45 minutes

IHC-OTM2

O.T. Mattress, ¾ Length (1200mm x 585mm)

65W

60 minutes

IHC-OTM2-N

O.T. Mattress, ¾ Length, Narrow (1200mm x 535mm)

65W

60 minutes

IHC-GTM1

O.T. Mattress, ½ Length (1070mm x 585mm)

55W

60 minutes

IHC-GTM1-N

O.T. Mattress, ½ Length, Narrow (1070mm x 535mm)

55W

60 minutes

Table 2 - Operating Theatre Mattress Details

Neonatal Mattress Part Number

Part Description

Wattage

Warming Up Time

IHC-NCM1

Neonatal Mattress, Small (610mm x 340mm)

55W

31 minutes

IHC-NCM3

Neonatal Mattress, Medium (610mm x 430mm)

40W

25 minutes

IHC-NCM5

Neonatal Mattress, Panda (660mm x 480mm)

35W

30 minutes

IHC-NCM9

Neonatal Mattress for LifeStart™

13W

37 minutes Table 3 - Neonatal Mattress Details

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Patient Warming System Instructions for Use

Recovery Room Blanket Part Number

Part Description

Wattage

Warming Up Time

IHC-RB1

Recovery Room Blanket (1660mm x 800mm)

58W

30 minutes

Table 4 - Recovery Room Blanket Details Note: Any Mattress can be used in combination with the Recovery Blanket Note: Warming Up Times shown are from 23°C to 37°C and are approximate

Mattress/Blanket Connection Cables Amphenol Connector (right-angled) Part Number

Part Description

IHC-1020-10

Connection Cable, 1m (right-angled)

IHC-1020-30

Connection Cable, 3m (right-angled) Table 5 - Mattress Blanket Amphenol Connecting Cable Details

Mattress/Blanket Connection Cables Amphenol Connector (straight) Part Number

Part Description

IHC-1021-10

Connection Cable, 1m (straight)

IHC-1021-30

Connection Cable, 3m (straight) Table 6 - Mattress Blanket Amphenol Connection Cable Details

Skin Probes Part Number

Part Description

TCFMT400/ AS-THT

Re-usable Skin Probe (supplied by Metko) (not for USA)

TCFMT400/ ASD Disposable Skin Probe (supplied by Metko) (not for USA) TCFMT400/ AECTHT

2 pin Redel Connector Table 7 - Skin Probe Details

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2. Symbols Warning: Read fully these operating instructions as they may affect safety or prevent damage The use of this equipment requires detailed knowledge and the observation of the Instructions for Use. This device is only intended for the described use Product complies with the provisions of the Medical Device Directive (93/42/EEC) Defibrillation Proof Type BF Equipment

1 2 3 4

1 The AlphaCore5 Controller is only compatible with the following patient warming accessories: Part Number

IHC – OTM1 IHC – OTM1-N IHC – OTM2 IHC – OTM2-N IHC – GTM1 IHC – GTM1-N IHC – NCM1 IHC – NCM3 IHC – NCM5 IHC – NCM9 IHC – RB1 2 Partial covering of the mattress/blanket device by pillows or other items having good insulating properties may impair the heating performance of the device 3 Mattresses and blanket should be used flat and unfolded 4 Mattresses and blanket can be used with direct patient contact or separated with a layer of fabric

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Patient Warming System Instructions for Use

Do not use Gel Pad(s)

Serial number

Patients lie on top of mattresses

Do not use if package is damaged

Patients lie underneath blanket

Keep dry

Printed side up

Keep away from sunlight

Do not fold it

Not for General Disposal

Roll it if necessary with print facing outwards

Humidity limitation (10% to 70% RH) 40

Patient temperature probe input

Manufacturer

Limit of temperature (-10°C to 40°C)

Caution: United States Federal law restricts this device for sale by or on the order of a physician

Mattresses and blanket may become damaged or perforated by sharp objects or instruments

Catalogue number

IP32

Mattresses / Blanket are rated to a degree of Ingress Protection (IP) 32

IP3X

AlphaCore5 Controller is rated to a degree of Ingress Protection (IP) 3X

Date of Manufacture

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3. Safety Intended Use The Inspiration Healthcare Limited Patient Warming System, consisting of a AlphaCore5 Controller, heating mattresses and blanket, is a system for use in supporting the maintenance of a patient’s core body temperature within the normothermic range between 36.5°C and 37.5°C. The patient applied parts of mattresses and blanket are for either neonatal or paediatric to adult patient ranges. An independent device should be used to regularly measure the patient’s core body temperature whilst the system is in use. Indication for Use To support the maintenance of normothermia in patients at risk or who may become at risk of inadvertent hypothermia within a hospital setting. The system should be used for all age ranges from Neonatal to Adult. Contraindications It is the responsibility of the user to determine whether warming is appropriate for each individual patient. The Patient Warming System should not be used on patients where clinical considerations indicate that warming of the patient is not advisable (e.g. aortic cross clamping). Caution should be used when using mattresses and blanket were patients have ischemic limbs. The Inspiration Healthcare Limited Patient Warming System and all its accessories are not MRI compatible. A potential increase in delivery of transdermal medications when in direct contact with either mattresses or blanket (for example, skin patches) may cause patient harm. Inspiration Healthcare Limited W inspiration-healthcare.com

Avoid direct contact with mattress or blanket in circumstances where patient’s skin is compromised. Warnings The user should carefully read the instructions for use before using the Patient Warming System AlphaCore5 Controller, mattresses and blanket to become familiar with the function of the equipment. On a monthly basis, the user should check the functionality of the thermal cut out by following the instructions in Section 9. This functional test must not be used when a patient is in contact with the warming accessory. Do not use the Patient Warming System if there is any sign of damage. Ensure the surface integrity of the mattresses and/or blanket and replace if necessary. Do not use the Patient Warming System in the presence of flammable anaesthetic gases or oxygen enriched atmospheres (zone of high risk) as these may pose an explosion hazard. Do not position the AlphaCore5 Controller in the path of a direct X-ray beam (mattresses and blanket are radiolucent and their performance will not be affected by X-ray activity). The time for the mattresses and blanket to reach a set temperature of 37°C from ambient (23°C ± 2°C) will vary depending on the size, with a maximum estimated time of 30 minutes for the smallest to 45 minutes for the largest (these may increase over the lifetime of the product). The AlphaCore5 Controller displays the heated element temperature, not the patient contact temperature. Whilst these may be very similar the actual contact surface may be between 1 and 3°C lower than the displayed temperature.

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The AlphaCore5 Controller has an alarm system with an interruption of power supply mains alarm condition. Do not use the blanket/mattresses with any AlphaCore5 Controller or connection cables other than those supplied with the system, or approved by Inspiration Healthcare Limited.

Pooling of surgical preparation solutions under the patient is specifically contraindicated, due to risk of skin irritation. Do not allow surgical skin preparation solution to pool under the patient. The AlphaCore5 Controller is only compatible with the following patient warming accessories: IHC-OTM1

O.T. Mattress, Full Length (1900mm x 585mm)

IHC-OTM1-N

O.T. Mattress, Full Length, Narrow (1900mm x 535mm)

IHC-OTM2

O.T. Mattress, ¾ Length (1200mm x 585mm)

IHC-OTM2-N

O.T. Mattress, ¾ Length, Narrow (1200mm x 535mm)

IHC-GTM1

O.T. Mattress, ½ Length (1070mm x 585mm)

IHC-GTM1-N

O.T. Mattress, ½ Length, Narrow (1070mm x 535mm)

IHC-NCM1

Neonatal Mattress, Small (610mm x 340mm)

IHC-NCM3

Neonatal Mattress, Medium (610mm x 430mm)

IHC-NCM5

Neonatal Mattress, Panda (660mm x 480mm)

Do not position the AlphaCore5 Controller in such a way as to make it difficult to disconnect the mains lead.

IHC-NCM9

Neonatal Mattress for LifeStart™

IHC-RB1

Recovery Room Blanket (1660mm x 800mm)

If disconnection from the mains power should be necessary, the IEC mains lead should be detached from the AlphaCore5 Controller or from the mains socket.

Partial covering of the mattress/blanket device by pillows or other items having good insulating properties may impair the heating performance of the device.

In the event of a power failure, use a back-up Power Supply such as a UPS (Uninterruptable Power Supply) or Institutional back-up generator.

Mattresses and blanket should be used flat and unfolded.

The mattresses/blanket are not to be wrapped around the patient. Ensure the surface of the mattress or blanket has no folds or creases and check that the surface is not damaged prior to placing on the operating table or trolley. Do not use if there is any damage, perforation or wear. Do not partially cover the mattresses with insulating materials like pillows/blankets. It is important to ensure that the mattress is firmly secured and that the straps cannot slide off the operating table brackets’ in relation to the operating theatre mattress. No part or accessory to the Patient Warming System can be maintained or serviced while the system is in use. To avoid the risk of electric shock this equipment must only be connected to an electrical supply with a protected earth.

The Patient Warming System is not sterile. Where necessary the user should take appropriate precautions to protect the sterile field. Inspiration Healthcare Limited W inspiration-healthcare.com

Mattresses and blanket can be used with direct patient contact or separated with a layer of fabric. Channels which are not in use should be left covered.

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4. System Description/Application Disclaimers

AlphaCore5 Controller

Inspiration Healthcare Limited assumes no responsibility for the use or reliability of its Patient Warming System AlphaCore5 Controller, mattresses or blanket if they are not used correctly as a system in conjunction with appropriate accessory mattresses, blanket and AlphaCore5 Controllers authorised for use by Inspiration Healthcare Limited.

The AlphaCore5 Controller is a precision temperature Controller to be used only in conjunction with the low voltage, electrically heated Inspiration Healthcare Limited branded blanket/mattresses.

Inspiration Healthcare Limited makes no warranty of any kind with regard to other manufacturer’s Controller , mattress or blanket applications that are created to be used in conjunction with Inspiration Healthcare Limited devices by the user. This document contains confidential and proprietary information that is protected by copyright. All rights are reserved. Any unauthorised copying, storage, reproduction or translation of this document in any form is strictly prohibited. User Profile Designed for use by, or under the supervision of, a registered medical professional (Doctor, Midwife Nurse or Practitioner) in the operating room, recovery room, anaesthetic room, intensive care, emergency department, and/or medical, obstetric, maternity and surgical wards.

Mains voltage is supplied to the AlphaCore5 Controller via an IEC socket and IEC mains lead. There is a device on/off button at the top of the unit and a touchscreen interface along with the active/alarm bar which illuminates when power is connected, and the on/off button is pressed. At the top is a carrying handle and to the rear is a clamp to allow the unit to be mounted on an IV pole, anaesthetic trolley or Medi-rail. At the front of the unit is a touchscreen GUI (Graphical User Interface) (see Figure 2) control panel from which all the functions can be accessed. There are five yellow ODU-style connection points, three at the front and one on either side to allow for the connection of up to five accessories: mattresses in combination with blanket. The connection cables are provided for mattresses/blanket in a number of lengths and configurations. There is a blue ODU-style connector on the right-hand side of the device for a patient temperature probe. There is an IEC socket on the left-hand side of the device for mains power input. The AlphaCore5 Controller input is protected by two 3Amp fuses which are accessible on the side of the unit underneath the IEC socket (for qualified service personnel only). The AlphaCore5 Controller provides a 26Vdc supply to the mattresses/blanket and receives temperature information back. The temperature setting is controlled and indicated on the GUI. When the mattresses/blanket are warming up the channel indicator will be blue, if passively cooling from a

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Patient Warming System Instructions for Use

higher set temperature to a lower one the channel indicator will be amber and green when at the set temperature.

A pressure relief pad is integrated into the mattress underneath the flexible warming surface to work in conjunction with the operating table mattress. This may help reduce the incidence of pressure sores, without any attenuation of the warming performance. Integral straps are used to retain the mattress in-situ.

The blanket is designed to operate over the patient and constructed in the same manner as the mattresses, but without the pressure relief pad which is replaced by a soft insulating material.

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Figure 2 - AlphaCore5 Controller GUI

The maximum working power output is equivalent to controlling two full size mattresses (IHC-OTM1) irrespective of configuration (170 watts). There is no active cooling with this device, reduction in accessory temperature is passive and will not decrease below ambient. Mattresses and Blanket Mattresses must be fitted with the marked side uppermost, and the plain surface facing downwards. The blanket is to be placed over the patient with the writing uppermost, away from the patient. Mattresses are available in various sizes and are only designed to operate under the patient. They provide an even temperature over the whole surface and are extremely flexible. The basic construction of mattresses across the range is the same. The mattresses are water and solvent resistant and have been tested for bio-compatibility to allow skin contact during use. All seams are fully sealed by RF Welding.

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On initial start-up, if the ambient temperature is low, the mattress/blanket will take longer to achieve the desired temperature. If the desired temperature is not achieved within the defined warming up time, there will be a visual and audible indication. Should this happen, the AlphaCore5 Controller will continue to power up the mattress/blanket until the desired temperature is achieved. The mattresses/blanket contain a special conductive heating material and will not cause any environmental heating. The heat emitted by this material will only be felt by the user/patient when applying pressure or weight to the mattress. It is normal that the mattresses/blanket do not feel particularly warm to the touch when left uncovered. The AlphaCore5 Controller monitors temperature and when the mattress/blanket reaches the desired temperature the AlphaCore5 Controller will maintain this automatically. If the maximum allowed temperature is exceeded, a visual warning indicator will be displayed, and the over-temperature alarm will sound. An internal safety cut-out system will operate if any fault condition causes the mattress/blanket to exceed a temperature of 41°C.

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5. Connection and Disconnection Refer to Section 1: Introduction for the list of connection cable options and accessories. Power to the AlphaCore5 Controller Power can be applied from two sources: a mains cable and the internal battery. The internal battery will only support the independent use of the NCM-9 mattress for a minimum of 30 minutes (from fully charged). The mains power input is 100-240Vac, 50-60Hz. The battery is on continuous charge whilst mains power is connected, and the AlphaCore5 Controller turned on. To connect the mains cable, hold the connector body and push into the mains socket. To remove the cable, hold the connector body and pull, do not twist or pull by the cable. The AlphaCore5 Controller can be powered via other medical devices, provided that they have an isolated earth.

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Power from the AlphaCore5 Controller Connection cables are provided to take power and control signals between the mattresses/blanket and AlphaCore5 Controller . Warning: Do not force the connector into the socket. Ensure it is correctly orientated by aligning the directional arrow on the connector body with the marker on top of the terminal housing. ODU Connector For connection to the AlphaCore5 Controller, there is a choice of right angled and straight ODU-style connectors which are colour coded yellow. The right-angled connector is designed to point the cable downwards, away from the display. The connector pushes into the yellow terminals on the AlphaCore5 Controller. The connectors are keyed – align keying before pushing home – never force connectors. To disconnect, hold the main body of the connector and pull. Do not twist or force the connection.

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Patient Warming System Instructions for Use

Amphenol Connector

Patient Probe

The Amphenol connector at the opposite end of the connection cable plugs into the connector fitted to the mattress/blanket. Align the plug and socket then push together and rotate the black collars clockwise to lock the connection as shown below.

The patient probe is connected with an ODU-style connector to the blue connection on the righthand side of the AlphaCore5 Controller This can be connected and disconnected to the AlphaCore5 Controller as described in ODU Connector section above.

Warning: Clinical decisions should not be made based on the patient temperature probe reading of the AlphaCore5 Controller – it is for indication only. Do not attempt to force the connectors and pay attention to the orientation of the plugs for proper connection.

The ODU-style connectors are all keyed (and colour coded) so that only a mattress cable can be plugged in to the mattress output; only the patient probe can be connected to the patient probe input. To disconnect, hold the connector locking rings, rotate counter-clockwise and then pull them apart.

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6. AlphaCore5 Controller Start-Up AlphaCore5 Controller Start-Up Cycle

Bootloader MEDIUM PRIORITY ALARM Test

After pressing the power button and the unit powers up, the bootloader screen is displayed. At the final stage of the bootloader process the HIGH, MEDIUM, and LOW alarm audible signals should each be initiated for a signal alarm burst. At the same time, the visual alarm bar at the top of the unit should be illuminated RED or AMBER according to the priority of the audible alert being sounded.

The visual alarm bar should be illuminated in AMBER. The audible alarm should complete at least one full sequence of the MEDIUM PRIORITY ALARM tone.

Bootloader Screen In the first stage of the bootloader, the visual alarm bar should be GREEN and there should be no audible alarms sounding.

Bootloader LOW PRIORITY ALARM Test The visual alarm bar should be illuminated in AMBER. The audible alarm should complete at least one full sequence of the LOW PRIORITY ALARM tone.

Bootloader HIGH PRIORITY ALARM Test The visual alarm bar should be illuminated in RED. The audible alarm should complete at least one full sequence of the HIGH PRIORITY ALARM tone.

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Commence Normal Operation After completing the alarm system test, the bootloader should complete and the unit commence normal operation. At this point all audible alarms should be turned OFF and the visual alarm bar illuminated GREEN (unless real alarms are active).

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7. System Setup Connect and utilise the AlphaCore5 Controller , mattresses/blanket with consideration to safety as outlined in Section 3. Control Descriptions Below is a list of meanings of all the buttons on the display and indicator lights:

Power on and off: 3 second hold

8 2

1 5 6

1. Settings menu 2. Power source and battery status 3. Mains connected 4. Accessory connection status 5. Increase desired temperature 6. Decrease desired temperature

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7. Initial accessory connection indication (with associated active alarm bar amber)

8. Device status and alarm bar green okay and amber active 9. Set temperature target of accessories 10. Patient probe connected and temperature measured

Settings Screen (with active choices in green) V1.0.0 (PMU v1.0)

1. Clock and Calendar adjustment option screens

2. Degrees Celsius or Fahrenheit (for patient probe temperature display) 3. Decimal point or comma

4 5

4. Screen locked or unlocked 5. Tick press to confirm

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Clock and Calendar Adjustment Screens Calendar Adjustment Screen

Clock Adjustment Screen

00:00

00-00-00

DD - MM - YY

3 4

1. Adjustment up arrow 2. Adjustment down arrow 3. Hours 4. Minutes 5. Tick for confirmation of settings 6. Day – Month – Year

1. Settings icon faded whilst screen lock is active

2. Screen Locked icon

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How to Use the AlphaCore5 Controller Securely mount the AlphaCore5 Controller to either a pole or Medi-rail using the clamp provided. The device can be used free standing; however, it should be positioned with due consideration to the local environment and safety. Rail Mount

Pole Mount

Connected to the mains supply, press the on/off switch to the top right of the display for 3 seconds. The device will power up with the touchscreen displaying the target temperature. To the left of this temperature value are up/down arrows which, when pressed, adjust the temperature in 1°C steps to enable the desired temperature to be set. Note: pressing and holding the arrows will not increase or decrease the value by more than 1°C. The temperature range is 25-40°C in 1°C increments. The touchscreen will display icons as indicated below.

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On the top right of the display a battery icon, mains power connection icon, charging icon and a status bar will be shown. If a patient probe is connected, a smaller blue icon will be visible displaying the probe temperature (below and to the right of the main temperature setting display). If a temperature probe is not attached, this icon will not be displayed.

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Along the bottom of the screen, there are five accessory boxes related to the potential number of accessories that can be active at any one time (five in all). If none are connected, they will all remain grey.

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Once an accessory mattress or blanket is connected the related grey box will flash amber, a repeating beep will be heard and the status bar above the general display will be amber.

The flashing amber box should be pressed to confirm connection of the accessory. The status bar will turn green, the beeping will stop, and the associated accessory box will be blue if under temperature and warming.

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AlphaC

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If the attached accessory is above the set temperature, the associated accessory box will turn amber.

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51.4784

When the set temperature is reached, the accessory box will turn green. Note that there is no active cooling.

If the accessory monitored temperature is 1oC over the set target temperature for 1 minute, the device will alarm with a repeating beep. The related accessory box will flash amber and the status bar will also turn amber. To silence this and confirm observation, press the accessory box flashing amber. The box will remain amber until the temperature of the accessory normalises. The alert condition will return if the temperatures do not become normalised. This applies to any number of accessories connected individually.

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51.4784

If an accessory is disconnected, the device will alarm with a repeating beep, the status bar will turn amber, and the related accessory box will flash amber with a white ‘disconnected plug’ icon. To accept the disconnection, press the related icon and the alarming box will return to grey. Should the disconnection be accidental then reconnect to the AlphaCore5 Controller and reset the alarm condition by pressing the associated box (the ‘unplugged’ icon will disappear). Accept connection by pressing the accessory box again and the colour of the box will change from amber to the appropriate status as previously described.

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