Inditherm Patient Warming Systems Operating Instructions Rev 2.18 Aug 2015

Inditherm Operating Instructions

Contents: Page Introduction

1

Description of Parts and Range of Products

2

Symbols

3

Safety

4

System Description

5

Setting Up

6

Connecting & Disconnecting

6

Storage

7

Use of Clamps with Mattress

7

Operation of Control Unit (MECU1) Before Use Control Unit Start Up Cycle Control Descriptions Language Selection Temperature Selection

7 7 8 8 9 9

Use and Care of Mattresses and Blankets

9

General Performance

10

Infection Control & Cleaning Instructions

11

Problem Solving & Warning Messages

12

Technical Specification

13

© Inditherm plc, 2015 Copyright: All rights reserved. No part of this handbook may be reproduced, stored in a retrieval system or transmitted in any form or by any means electronic, mechanical, photocopying, recording or otherwise, without the prior permission of Inditherm plc

Patient Warming Systems

Rev. 2.18 : 20-08-2015

Operating Instructions

Introduction:

The Inditherm Patient Warming Systems are designed for use in the operating room, recovery room, anaesthetic room, intensive care and emergency department. They provide safe and controlled warming to assist patients to maintain normal body temperature. The warming medium is available as:  A mattress for use under a patient  A recovery blanket or operating room blanket to be placed over a patient. In addition to warming, the mattresses also include a pressure-relieving pad. This is achieved using an integral pressure relieving foam pad under the flexible heating surface, ensuring no degradation of heating performance. Different sizes and models of mattress and blanket are available for various procedures and situations. They are sealed to prevent ingress of fluids and allow cleaning. Integral straps are provided to ensure mattresses can be securely fastened to the operating table or trolley. The system is powered and controlled by an electronic control unit. The mattresses and blankets are powered at low voltage, ensuring safety for patients and operators. The temperature is controlled automatically to user-selected level. An over-temperature safety cut-out is integrated into each mattress and blanket. The control unit can be placed on a flat surface or mounted on an IV pole, anaesthetic machine, etc. It has a standard mains supply input and a working voltage of 24Vac to the mattress or blanket. The system has 4 pre-set operating temperatures of 37, 38, 39 and 40C and is designed to be operated continuously, maintaining a uniform heat under or over the patient.

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Operating Instructions

Description of Parts and Range of Products Note: Any mattress / blanket can be used with any control unit.

Model

Size

Description

OTM1

1900 x 585 x 40 mm

OTM1 N

1900 x 535 x 40 mm

OTM2

1200 x 585 x 40 mm

OTM2 N

1200 x 535 x 40 mm

GTM1

1070 x 585 x 40 mm

GTM1 N

1070 x 535 x 40 mm

PTM1

560 x 500 x 40 mm

Operating Room Neonatal Mattress

OTB1

500 x 1070 x 40 mm

Operating Room Blanket, Long

OTB2

870 x 500 x 40 mm

Operating Room Blanket, Short

RB1

1660 x 800 x 40 mm

Recovery Room Blanket, Full length

RB2

1660 x 1200 x 40 mm

Recovery Room Blanket, Wide

MECU1

160 x 240 x 230 mm

Electronic Control Unit

Operating Room Mattress, Full Length

Operating Room Mattress, ¾ Length

Operating Room Mattress, ½ length

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Operating Instructions

Symbols: Warning Read fully these operating instructions as they may affect safety or prevent damage

Type BF Equipment

Class II Equipment

LATEX

Latex Free

Mains Switch I (On) Power connected to the mains supply O (Off) Power disconnected from mains supply Alternating Current

Product complies with the provisions of the Medical Device Directive (93/42/EEC) 0473 Within European Union product must be disposed of in accordance with WEEE Directive

Enable

Scroll

Alarm Cancel / Reset

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Safety: Indications for Use Designed for use in the operating room, recovery room (PACU), anaesthetic room, intensive care, emergency department, on medical and surgical wards, and for patient transport, the Inditherm patient warming system provides safe and controlled warming to assist patients to maintain normal body temperature. In addition to providing warming, the mattress also includes a pressure relief pad.

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.

Warnings Do not use the warming system if there is any sign of damage. Ensure any damaged item is checked and/or repaired by a qualified engineer or technician. Do not use the system in the presence of flammable anaesthetic gases or oxygen enriched atmospheres as these may pose an explosion hazard. Do not use gel pads on the mattress surface as this may compromise the control of the warming system Precautions Refer to section on Storage to prevent damage to the mattress or blanket. Ensure the mattresses and blankets are not folded or creased, and do not store any other product or item on top of the mattress. Refer to section on Setting Up to ensure patient safety. The mattress must be fitted to the operating room with the printed side towards the table and the plain surface uppermost. Refer to section on Use and Care of Mattresses and Blankets to prevent damage, ensure patient safety and obtain best performance. Refer to section on Use of Clamps to prevent damage to the mattress and ensure patient safety. Refer to section on Operation of Control Unit to prevent damage to the product and ensure safety of the user and other staff. Refer to sections on Infection Control and Cleaning to ensure safety. Pooling of most surgical prep solutions under the patient is specifically contraindicated, due to risk of skin irritation. Warming may exacerbate this, so ensure instructions for use of prep solution are followed. The Inditherm patient warming system is not sterile. Where necessary the user should take appropriate precautions to protect the sterile field.

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

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Operating Instructions

System Description Control Unit The control unit is a precision temperature control unit to be used in conjunction with the electrically heated blanket or mattress. Mains voltage is supplied to the control unit via a captive mains lead. A recess is provided to allow the mains cable to be safely coiled around the unit when not in use. There is a power switch on the right side of the unit that illuminates when the power is on. At the top is a carrying handle and to the rear is a clamp to allow the unit to be mounted on a pole or anaesthetic trolley.

Warning Indicator

On the front of the unit is a display and control panel from which all the functions can be accessed, there are three control buttons, and an LCD display. The cable for the mattress or blanket is at the front.

LCD Screen

The control unit input is protected by a 1600mA fuse, which is accessible from the base of the unit. The control unit provides a 24Vac supply to the mattress or blanket and receives temperature information back. The temperature setting is indicated on the display. The unit automatically adjusts to the type of mattress or blanket connected.

Enable Button

Scroll Button

Alarm Cancel / Reset Button

Mattress The mattress is available in various sizes and is only designed to operate under the patient. The mattress provides an even temperature over the whole surface and is extremely flexible. The basic construction of the mattresses remains the same throughout the range. 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 and are latex free. The internal patented Inditherm carbon polymer material provides the heat source, and an internal temperature sensor provides the output to the control unit for temperature control. The mattress has a thermal protector that will not allow the mattress to overheat. A pressure relief pad is integrated into the mattress, underneath the flexible warming surface. This helps reduce the incidence of pressure sores without any attenuation of the warming performance. Integral straps are used to retain the mattress in-situ. Blanket The blanket is designed to operate over the patient. There are two types of blanket available, both are 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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Setting Up Ensure the surface has no folds or creases and check that the surface is not damaged prior to securing the product to the operating table. Do not use if there is any sign of damage or wear. The mattress must be fitted with the printed side towards the table and the plain surface uppermost. The mattress can be fixed to the table via the straps and press-studs as shown. Straps should be secured on both sides. A number of press-studs are provided on each strap; use those which allow most secure fastening of the mattress to the table or trolley. It is important to ensure that the mattress is firmly secured and that the straps cannot slide off the operating table brackets. Note that strap positions vary depending on size of mattress. Mattresses can be manufactured with customised strap positions and lengths if required. See section on Operation of Control Unit (MECU1) for further information on setting up.

!

Connecting & Disconnecting A connection cable is provided to take power and control signals between the mattress or blanket and the control unit. Note: Do not force the connector into the socket. Ensure it is correctly orientated. Two types of connector are used, depending on specification. BLACK Connector: The Black connector plugs into the connector fitted to the mattress or blanket. Align the plug and socket and push together. It should be possible to feel a “click” as the connectors engage. To disconnect, hold the connector bodies and pull them apart. Note: Do not attempt to rotate or unscrew the connectors. It is important to pull them apart straight, do not bend or twist them. BLUE Connector: The Blue connector plugs into the connector fitted to the mattress or blanket. Align the plug and socket and push fully together. Rotate the ribbed collars clockwise to lock the connection. To disconnect, rotate the collars anti-clockwise to unlock and pull the connectors apart.

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Storage & Care To ensure the mattress is not damaged during storage, either keep flat or loosely roll the mattress with the printing on the inside. Do not fold the mattress. Do not store any other product or item on top of the mattress! Check the mattress or blanket for signs of damage before each use. Avoid storing Control Unit, mattresses or blankets in direct sunlight.

!

Use of Clamps with the Mattress The use of operating table clamps and similar devices may cause damage to the product and result in loss of the heating function and / or localised heat build-up in the damaged area. When using clamps, it is essential to avoid clamping the mattress. If clamping to the mattress is likely to be unavoidable, please contact Inditherm to discuss your special needs.

!

Operation of Control Unit (MECU 1) Before Use Check that the control unit is configured for the local supply voltage, as shown on the rating label on the underside of the control unit. Clamp the control unit to an IV or accessories pole or place in a suitable position on a flat surface. Connect the unit to a suitable mains supply and position the lead so it does not cause a hazard. Excess length of mains lead can be wrapped around the cable stowage channel on the control unit. Connect the socket on the control cable to the plug attached to the mattress or blanket.

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Operating Instructions

Control Unit Start-Up Cycle Turn on the power switch (green button) on the side of the unit and ensure the switch illuminates to indicate power on. The system will follow the cycle below:

Display Screen Readout

Action Required

Information Bleep will be heard on switch on First screen indicating initialisation started and software version If required language is set, take no action and system will automatically continue Bleep will be heard

Inditherm V2.03E

None

English UK  to change language

Option to change Language See Language Selection

Language English UK

None

Screen Indicates Language

System Check

None

Bleep will be heard Automatic system test Bleep will be heard

System OK

None

User indication that system is OK

Alarm Check

None

Alarm OK

None

 37 °C 

User can change temperature at this point See Temperature Selection

 37 °C 

User can change temperature at this point See Temperature Selection

 37 °C 

User can change temperature at this point See Temperature Selection

Bleep will be heard Automatic test of alarm sound Bleep will be heard User indication that alarm ok Bleep will be heard Display showing temperature. Unit automatically selects last temperature used. Arrows point upwards, indicating system is warming up, until desired temperature is achieved. Display showing temperature. Arrows point horizontally, indicating desired temperature is achieved. Display showing temperature. Arrows point downwards, indicating system is cooling down, until set temperature has been achieved.

Control Descriptions Warning Indicator

LCD Screen

Enable Button

Patient Warming Systems

Scroll Button

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Alarm Cancel / Reset Button

Rev. 2.18 : 20-08-2015

Operating Instructions

Language Selection The language can only be changed at the appropriate point in the start-up sequence, see section on Control Unit Start-Up Cycle. The language can be set to one of the following: English °C, English °F, Spanish, French, German, Italian, Polish When Language is displayed in the start-up sequence, press and hold down the Enable Button. While holding down the Enable button, press and release the Scroll button to set the required language, the unit will cycle sequentially through the available languages each time the Scroll button is pressed and released. When the required language is shown release the Scroll and Enable buttons.

Temperature Selection The temperature can be set at any time after the self-test start up cycle has completed, the following temperatures can be set: 37C

38C

39C

40C

To adjust the temperature, press and hold down the Enable Button and then press and release the Scroll button to set the required temperature. The unit will cycle sequentially through the temperatures each time the Scroll button is pressed and released. When the required temperature is shown release the Scroll and Enable buttons. When the system is first switched on it will default back to previous temperature setting that was used.

!

Use and Care of Mattresses and Blankets Do not allow sharp objects to penetrate the mattress / blanket. Inspect the surface before and after each use. Mattresses and blankets should not be used if there is any sign of damage. Do not use the blanket / mattress with any but the supplied control unit and connecting leads. You should not use gel pads. Use of gel pads may cause a loss of warming performance, as the mattress would have to heat the gel pad first. A clinical study on healthy volunteers suggests that the Inditherm system may provide better pressure relief than gel pads or standard operating table mattresses1. The operator should consider whether it is necessary to restrain the patient under or on the blanket / mattress.

Baker EA, Leaper DJ: Pressure-relieving properties of an intra-operative warming device. J Wound Care, 2003, 12:4, p. 156-140. 1

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Operating Instructions

General Performance On initial start up, if the ambient temperature is low, the mattress / blanket will take longer to achieve the desired temperature. If the selected temperature is not achieved within 40 minutes a Low Temperature warning will be displayed for one minute and an alert tone will sound for 20 seconds. The system will continue to warm the mattress / blanket. The alert tone may be silenced if desired by pressing the Alarm Cancel button. The system will automatically re-check every 20 minutes thereafter to confirm that the selected temperature is achieved. The alert will repeat if appropriate. If the alert persists then consult a qualified engineer. The mattress will not cause any environmental heating and contains a special conductive heating material. The heat given off by this material will only be felt by the user / patient when applying pressure / weight to the mattress. It is normal that the mattress or blanket do not feel particularly warm to the touch when left uncovered. The control unit will monitor temperature performance, and when the mattress/blanket reaches the desired temperature the control unit will stop heating the mattress/blanket. If the maximum allowed temperature is exceeded the over temperature alarm will sound. An internal safety cut-out temperature management system will operate if any fault condition causes the mattress/blanket to exceed a temperature of 43C. For best performance it is recommended that the system is switched on and left to run at set temperature in advance of placing the patient.

Guidance and manufacturer’s declaration – electromagnetic emissions The systems are intended for use in the electromagnetic environment specified below. User should assure use is in such environment Emissions test Compliance Electromagnetic environment - guidance RF emissions Systems use RF energy only for internal function. RF emissions are very low and unlikely to cause Group 1 CISPR 11 interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Class A Systems are suitable for use in all establishments, including domestic establishments and those IEC 61000-3-2 directly connected to the public low-voltage power supply network that supplies them. Voltage fluctuations / flicker emissions Complies IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The systems are intended for use in the electromagnetic environment specified below. User should assure use is in such environment Immunity test IEC 60601 test level Electromagnetic environment - guidance Electrostatic discharge (ESD) ±6kV contact Floors should be wood, concrete or ceramic tile. If floors are synthetic Pass IEC 61000-4-2 ±8kV air material, relative humidity should be at least 30% Electrostatic fast transient / burst ±2kV power supply lines Mains power quality should be that of a typical commercial or hospital Pass IEC 61000-4-4 ±1kV input/output lines environment Surge ±1kV line to line Mains power quality should be that of a typical commercial or hospital Pass IEC 61000-4-5 ±2kV line to earth environment Voltage dips, short interruptions and <5% UT for 0.5 cycle Mains power quality should be that of a typical commercial or hospital voltage variations on power input 40% UT for 5 cycles Pass environment. If the user requires continued operation during mains lines 70% UT for 25 cycles power interruptions the battery option should be fitted or a UPS used. IEC 61000-4-11 <5% UT for 5 sec Power frequency (50/60Hz) magnetic If interference is suspected it may be necessary to move the system field 3 A/m Pass further from sources of power frequency magnetic fields or install IEC 61000-4-8 magnetic shielding. Note: UT is the ac mains voltage prior to application of the test level

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Operating Instructions

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Infection Control and Cleaning Instructions Infection Control Infection control and routine cleaning should be carried out in accordance with the local Infection Control Policy. Products should be decontaminated prior to servicing or return to the supplier. If returning product to Inditherm or local distributor, then a decontamination certificate must accompany the product and a copy of the certificate should be affixed securely to the outside of the packaging. Cleaning Guidelines Ensure the control unit is disconnected from the mains electricity supply before cleaning it. Clean mattress and control unit with care using a damp soapy cloth and / or disinfectant wipes. There is no need to disconnect the mattress or blanket from the power supply during routine cleaning. After cleaning control unit dry thoroughly before use. For mattresses and blankets only; where higher level of decontamination is required, use Sodium Hypochlorite (bleach) solution, or similar, (up to 10,000 ppm available Chlorine). Note that after cleaning with bleach solution the mattress or blanket should be rinsed and dried, in accordance with normal instructions for use. Preparation and use of the cleaning agent should be carried out in accordance with the instructions for use of the manufacturer of the cleaning agent.  Do not immerse the mattress, blanket or control unit in fluids.  Do not use Phenolic based products for cleaning.  Do not process the mattress, blanket or control unit in an autoclave, steriliser, automatic washer-disinfector or any other high temperature system.  Do not use cleaning or decontamination methods different from those recommended without first checking with Inditherm that the proposed methods will not damage the equipment.

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Operating Instructions

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Problem Solving & Warning Messages The Inditherm system has a number of features integrated that check for correct performance. These will generate warning messages if appropriate, which will be shown on the display and sound the audible alarm. These are described below.

Connect Mattress / Blanket: Indicates that either the mattress / blanket is disconnected, or possibly there is a fault with the connection cable or connector. Check that the connector is fully engaged. If this fails to clear the fault then press the Alarm Cancel button. If the error persists have the system checked by a qualified engineer. This error may also indicate a fault on the mattress / blanket internal temperature sensor.

Mattress Fault: Normally indicates there is a fault within the mattress / blanket or if the thermal safety cut-out operates due to a fault. Press the Alarm Cancel button. If problem persists then have the system checked by a qualified engineer. This message is also displayed if the internal fuse on the control unit output is blown.

High Temperature Detected: Indicates that the temperature has exceeded the maximum setting. In some cases this will not be experienced as the thermal safety cut-out will operate first.

Low Temperature Detected: Indicates either that mattress has failed to reach temperature in the prescribed period after switching on or that the temperature of the mattress / blanket has fallen below the set value. During the warm-up period if the set temperature is not reached after 40 minutes then this warning will be displayed, and an alert tone will sound for 20 seconds. The system will continue to warm the mattress / blanket. This cycle will repeat every 20 minutes thereafter until the set temperature is reached. This is an alert only, and normal operation can be continued. This typically may occur in a cold operating room when there is no patient on the mattress. The alert tone may be silenced if desired by pressing the Alarm Cancel button. The warning is only generated during the warm-up period if the temperature is more than 3ºC below set temperature. If apparent faults persist or if any other problems are encountered, then a qualified engineer should be consulted or you should contact Inditherm or their local distributor or representative.

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Operating Instructions

Technical Specification Mattress Construction:

Inditherm® flexible polymer heating sheet, with 18mm foam pressure relief pad under and 305g.m-2 expanded polyester comfort lining over. Encapsulated in latex-free, nylon fabric cover, with non-microporous polyurethane coating, fully sealed with RF welded seams. In-built temperature sensor and over-temperature thermal cut-out. Connection cable, 20 cm long, with strain relief, fully sealed entry grommet and IP61 rated waterproof connector. Sensors and cables let into pressure relief pad for patient comfort.

Temperature Range:

37°C to 40°C (99°F to 104°F) in steps of 1°C (2°F) Over-temperature safety cut-out at 43°C (109°F)

Power:

Control Unit:

230 Vac or 110Vac or 100Vac (±6%), 50Hz/60Hz 75 W

Mattresses:

24 Vac (nom.), 50Hz 25 W to 65 W, depending on size

Dimensions:

Control Unit:

160 x 240 x 230 mm

Mattresses:

Part Standard Narrow OTM1 1900 x 585 mm 1900 x 535 mm OTM2 1200 x 585 mm 1200 x 535 mm GTM1 1070 x 585 mm 1070 x 535 mm PTM1 560 x 500 mm OTB1 1070 x 500 mm OTB2 870 x 500 mm RB1 1660 x 800 mm RB2 1660 x 1200 mm Other dimensions available on request

Cable Length:

4m

Compliance:

Type Mattress Mattress Mattress Mattress Blanket Blanket Blanket Blanket

EN60601-1, Class IIb, Type BF EN60601-1-2 EN60601-2-35 93/42/EEC, EEC Medical Devices Directive 73/23/EEC, EEC Low Voltage Devices Directive

Environmental: Ambient Temperature (Operating):

15°C to 40°C (59°F to 104°F)

Ambient Temperature (Storage):

-10°C to 55°C (14°F to 131°F)

Relative Humidity:

30% to 70%

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Inditherm plc Houndhill Park Bolton Road Rotherham S63 7LG Tel: +44 (0) 1709 761000 Fax: +44 (0) 1709 761066 e-mail: [email protected] www.inditherm.com/medical