Operating Instructions
16 Pages
Preview
Page 1
CosyTherm Operating Instructions
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
7
Storage & Care
7
Operation of Control Unit (CCU1 & CRU1) Before Use Control Unit Start Up Cycle Control Descriptions Language Selection Temperature Range Selection Temperature Selection Standby mode Selection
7 7 8 9 9 9 10 10
Use and Care of Mattresses and Blankets
10
General Performance
11
Infection Control & Cleaning Instructions
11
Problem Solving & Warning Messages
12
Technical Specification
13
© Inditherm plc, 2010 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.
CosyTherm Systems
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Introduction:
The CosyTherm Systems are designed for use in the neonatal intensive care department, special care baby unit or maternity wards. They provide safe and controlled warming to assist newborn infants to maintain normal body temperature. The warming medium is available as: • A mattress for use under a patient • A blanket to be placed over a patient. In addition to warming, the mattresses also provide pressure relief. This is achieved using an integral foam pad under the flexible heating surface, ensuring no degradation of heating performance. Different sizes and models of mattress and blanket are available to suit different cribs. They are sealed to prevent ingress of fluids and allow cleaning. 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 a vertical pole. It has a standard mains supply input and a working voltage of 24Vac to the mattress or blanket. The system has different ranges of pre-set operating temperatures between 28 and 39°C and is designed to be operated continuously, maintaining a uniform heat under or over the patient.
CosyTherm Systems
-1-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Description of Parts and Range of Products Note: Any mattress / blanket can be used with any control unit.
Integrated Control Unit Output to blanket or mattress
Cosytherm Mattress
Remote Display & Control Panel
Output to blanket or mattress
Power Unit
Cosytherm Mattress
Model
Size
Description
NCM1
610 x 340 x 40 mm
Neonatal Mattress, Standard
NCM2
730 x 580 x 40 mm
Neonatal Mattress, Large
NCB1
450 x 500 x 40 mm
Infant Blanket
CCU1
160 x 240 x 230 mm
CosyTherm Control Unit - Integrated
CRU1
160 x 240 x 230 mm 145 x 85 x 56 mm
CosyTherm Control Unit - Remote
CosyTherm Systems
-2-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Symbols: Warning Read fully these operating instructions as they may affect safety or prevent damage
Type BF Equipment
Class II Equipment
Power Switch I (On) Power connected to the mains power supply O (Off) Power disconnected from mains power 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 CosyTherm Systems
-3-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
!
Safety: Indications for Use Designed for use in the Neonatal Intensive Care Unit (NICU), Special Care Baby Unit (SCBU), Paediatric Intensive Care Unit (PICU), delivery suite and post-natal wards and during transport, the CosyTherm system provides safe and controlled warming to assist newborn infants 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. 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 with the printed side down 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 Operation of Control Unit to prevent damage to the product and ensure safety of the user and other staff. The patient’s temperature should be monitored when using any warming system. Local hospital guidelines should be followed. Refer to sections on Infection Control and Cleaning to ensure safety. 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
CosyTherm Systems
-4-
Rev. 1.6 : 17-02-2010
Inditherm 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. Two versions are available, one fully integrated and the other with remote display and control panel. Mains voltage is supplied to the control unit via a captive mains power lead. A recess is provided to allow the 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 frame upright.
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.
Warning Indicator
The control unit input is protected by a 1600mA fuse, which is accessible from the base of the unit. LCD Screen
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 welding.
CosyTherm Systems
-5-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
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 provides pressure relief without any attenuation of the warming performance.
Blanket Blankets are designed to operate over the patient. These are constructed in the same manner as the mattresses, but without the pressure relief pad, which is replaced by a soft insulating material.
!
Setting Up Ensure the surface has no folds or creases and check that the surface is not damaged prior to placing in the crib. Do not use if there is any sign of damage or wear.
The mattress must be fitted with the printed side underneath, away from the patient, and the plain surface uppermost.
See section on Operation of Control Unit (CCU1 and CRU1) for further information on setting up.
CosyTherm Systems
-6-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
!
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.
!
Storage & Care To ensure the mattress is not damaged during storage, it should be kept flat. 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.
!
Operation of Control Unit (CCU1 and CRU1) 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 upright, IV or accessories pole or place in a suitable position on a flat surface. Ensure that the weight of the unit will not cause any risk that it can topple over the item it is attached to. Connect the unit to a suitable mains power supply and position the lead so it does not cause a hazard. Excess length of mains power cable can be wrapped around the cable stowage channel on the control unit. Connect the black socket on the control cable to the plug attached to the mattress or blanket.
CosyTherm Systems
-7-
Rev. 1.6 : 17-02-2010
Inditherm 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
Option to change Language See Language Selection
First screen indicating initialisation started and software version If required language is set, take no action and system will automatically continue
Language English UK
None
Screen Indicates Language
Temperature Range >change
Option to change Temperature Range See Temperature Range
If required range is set, take no action and system will automatically continue
Temperature Range 33-37
None
Screen Indicated Temperature Range
System Check
None
Automatic system test
System OK
None
User indication that system is OK
Testing Alarm
None
System OK
None
Automatic test of alarm sound Bleep will be heard User indication that alarm ok
∧ 33 °C ∧
User can change temperature at this point See Temperature Selection
> 33 °C <
User can change temperature at this point See Temperature Selection
∨ 33 °C ∨
User can change temperature at this point See Temperature Selection
Inditherm NCU1 V1.01 English UK > to change language
CosyTherm Systems
None
-8-
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.
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Control Descriptions Warning Indicator
LCD Screen
Enable Button
Alarm Cancel / Reset Button
Scroll Button
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 UK, English US, French, German, Spanish, Italian 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. English US shows temperatures in Fahrenheit and all other languages show temperatures in Celsius.
Temperature Range Selection The temperature range can only be changed at the appropriate point in the start-up sequence, see section on Control Unit Start-Up Cycle. The range can be set to one of the following: 33.0°C to 37.0°C in steps of 0.5°C 28.0°C to 35.0°C in steps of 0.5°C 32.0°C to 39.0°C in steps of 0.5°C When Temperature Range 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 range, the unit will cycle sequentially through the available ranges each time the Scroll button is pressed and released. When the required range is shown release the Scroll and Enable buttons.
CosyTherm Systems
-9-
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Temperature Selection The temperature can be set at any time after the self-test start up cycle has completed. The temperatures that can be set will depend on the range selected, and are changed in 0.5°C decrements. When changing temperature if the minimum of the range is reached then the next selection will scroll round to the maximum within the range. 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, or after Standby, it will default back to previous range and temperature setting that was used. The range can be changed at the appropriate point in the start-up cycle. If the range has been changed during the self-test start up cycle the temperature defaults to the lowest selectable temperature within the chosen range.
Standby Mode Selection Standby Mode allows the user to stop the unit from heating without turning off the power. This facility is provided for situations where a Remote Control Unit is in use and the On/Off switch is not easily accessible. Standby Mode can be selected at any time during normal operation. To set the system to Standby mode, which will turn off the heating, press and hold the Scroll and Enable buttons for at least 2 seconds and then release them. A message will request confirmation, which must be made in less than 2 seconds by pressing Scroll and Enable again. To return the system from Standby mode and resume heating press and hold the Scroll and Enable buttons for at least 2 seconds and then release them.
!
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. Gel pads are not required. Use of gel pads may cause a loss of warming performance, as the mattress would have to heat the gel pad first. Clinical evidence is available to support the Inditherm mattress performance in terms of pressure relieving properties, which are more effective than a gel pad.
CosyTherm Systems
- 10 -
Rev. 1.6 : 17-02-2010
Inditherm 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 desired temperature is not achieved within 25 minutes the alarm will sound. Should this happen select the Alarm Cancel / Reset button and the unit will restart and will allow a further 25 minutes for the desired temperature to be achieved. 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.
!
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. After cleaning control unit dry thoroughly before use. Where higher level of decontamination is required, use Sodium Hypochlorite (bleach) solution, or similar, (up to 10,000 ppm available Chlorine). After cleaning with bleach solution the mattress should be rinsed and dried. All cleaning agents must be used in accordance with manufacturer’s instructions for use. 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 or automatic washer-disinfector. Do not use cleaning or decontamination methods different from those recommended without first checking with Inditherm.
CosyTherm Systems
- 11 -
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
!
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: Normally 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. 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 25 minutes then this warning will be displayed. If Alarm Cancel is pressed then a further 25 minute warming up period will be initiated. If temperature is still low after the second period then the message will be displayed again. In this case the system should be checked by a qualified engineer.
If any other problems are encountered, then a qualified engineer should be consulted.
CosyTherm Systems
- 12 -
Rev. 1.6 : 17-02-2010
Inditherm Operating Instructions
Technical Specification Mattress Construction:
Inditherm® flexible polymer heating sheet, with 18mm foam pressure relief pad under and 205g.m-2 expanded polyester comfort lining over. Encapsulated in latex-free, nylon fabric cover, with non-microporous polyurethane coating, fully sealed with welded seams. In-built temperature sensor and over-temperature thermal cut-out.
Temperature Ranges:
33°C to 37°C (91°F to 97°F) in steps of 0.5°C (1°F)
(User Selected)
28°C to 35°C (82°F to 95°F) in steps of 0.5°C (1°F) 32°C to 39°C (90°F to 102°F) in steps of 0.5°C (1°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.) 20 W to 35 W, depending on size
Dimensions:
Control Unit:
160 x 240 x 230 mm
Remote Panel:
145 x 85 x 56 mm
Mattresses:
Part NCM1 NCM2 NCB1
Dimensions 610 x 340 mm 730 x 580 mm 450 x 500 mm
Type Mattress Mattress Blanket
Other dimensions available on request Cable Lengths:
Mattress Cable:
2 m with remote unit 1.5 m with integrated unit
Remote Panel Cable: Compliance:
1m
EN60601-1, Class IIa, 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%
CosyTherm Systems
- 13 -
Rev. 1.6 : 17-02-2010
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
©Inditherm plc 2010
CosyTherm Systems
Rev. 1.6 : 17-02-2010