Cocoon CWS 4000 User manual

COCOON
Essential care before, during and after surgery.
Convective Warming Machine
CE
Model CWS 4000
SERVICE MANUAL
Distributed by
CARE ESSENTIALS PTY LTD National
Unit 62, 170 Forster Road Phone [phone]
Me Waverley Vic 3149 Australia Fax [phone]
Email queries@careessentials com.au
Web www.careessentials comau
TM
PS
International
Phone [phone] Designed &
Fax [phone] manufactured
in Australia.
Copyright © 2003 Care Essentials Pty Lid

CONTENTS
IN O O ーー 2
2. OPERATION. нина нина 4
21. UnitSetup.......... νν νο ντ νο νο νε ντε τ εεττ ο ο εκτ κκωκκκεν εεττ τετ κκκωννωνν εεττ τετ ετεκ κκ κκν τε κε εεττ ετεκ κε κας 4
2.2、 Getting Stared nm eneret esserne 5
2.3. Unit Operation Procedure 00000 eee nenene nene 5
24 Symbols ON 6
3. SAFETY PRÉCAUTIONS iii KKK 7
A κκεεεεκκκας 7
3.2. Warmnnd 8. 7
3.3. Caution................................................. 111 en 7
34. Electromagnetic Interference.......................... ener 7
4. PREVENTATIVE MAINTENANCE eee eee nenene nenene 8
O eee eee ee nene ee K K K K AA K KA KA P P nene nné 8
4.2. Electrical Safety Inspection eee ekk k 8
4.3. Performance Inspection 111111 ининининнни 9
4.4. Temperature Limit Thermostat Test Procedure …............................................ 10
4.5. Filter Replacement iii лиинннни 12
5. TROUBLESHOOTING… せ κτ εεττ ετεκ κκ κος 13
5.1. Warming Blanket Will Not Inflate irei 13
5.2. Standby Indicator Will Not Light нии nm... 13
53. EguipmentRepairs.............................................. ee 13
6. SCHEMATIC DIAGRAM DESCRIPTION ινε нии ини 13
6.1. Control Boargd R RKK KE KAP ae nn nn 14
6.2. Sensor Board νε εντ ετων ωνκκεε εεττ λε εντ τε κε ενεωκκκεεκκεεεεεε εεττ εκ κκκκκ κε ε τε εκ κκαν 15
6.3... System Block Diagram................. m. 15
7. BOARD COMPONENT LEGENDS .Nt 16
7.1. Control Board... KG Rana nn hh hn 16
7.2. Sensor Board eee 17
8. SCHEMATIC DIAGRAMS ue 18
8.1. Control Board Schematic Diagram … せ … せ … せ ーー トーーーーーーーーーーーーー 18
8.2. Sensor Board Schenmatic Diagram .................... 19
8.3. System Block Diagram i 20
INC li 21
9.1. General Assembly e eee eh reeeen nn nn 21
9.2. Control Board... 22
9.3. Sensor Board........................... ee 23
10. WARRANTY EEE EEE KEE HHK H K KKK KEE 23
11. SPECIFICATIONS............................................ nr ero rcncnncoinnnnos 24
12. APPROVALS нии 25

Care Essentials CWS4000 Cocoon Warming System Service Manual
1. INTRODUCTION
It is a pre-requisite for all persons skilled in servicing medical devices to understand the
information contained in this Manual. Read and understand this Manual and the Operator
Manual and all precautions prior to servicing the Cocoon Convective Warming System.
When used with Care Essentials patient warming blankets, the Care Essentials CWS4000
provides a continuous method of warming patients and is intended for preventing and treating
hypothermia. The Cocoon Convective Warming System consists of a CWS4000 and a warming
blanket. A connecting hose conducts heated air from the CWS4000 to the warming blanket.
Figure 1 Convective Warming System
Care Essentials recommend that a program of regular routine maintenance, electrical safety
and performance inspections be instituted for the CWS4000 as described in Section 4 below.
The CWS4000 is a mains-powered, microprocessor-controlled device that delivers a continuous
flow of temperature-controlled air through a flexible hose to the warming blanket. The
temperature of the air delivered to the blanket can be set to one of six settings: ambient, 34°C,
37°C, 40°C, 43°C, or 46°C. When a temperature of 46°C is selected, the setting automatically
drops to 43°C after 10 minutes. The CWS4000 will not cool the air delivered to the blanket
below the ambient temperature of the room.
Air is drawn into the rear of the CWS4000 and passes through a bacteriological HEPA filter. The
CWS4000 includes a number of under- and over-temperature prevention systems and in a
temperature fault condition it automatically shuts down and signals an alarm.
This Manual presents all the relevant service information for the Care Essentials CWS4000
Cocoon Warming System. This information is provided as a service to engineering and technical
personnel. This information is intended for the fair purposes of operation and maintenance of
the CWS4000. It is provided as Commercial-In-Confidence material to the Care Essentials
Distributor or CWS4000 owner and shall not be made available to any other organization or
person without the specific written permission of Care Essentials.
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Care Essentials CWS4000 Cocoon Warming System Service Manual
While every attempt has been made to ensure this Manual is accurate and complete, no
responsibility is taken for any errors or omissions. Care Essentials has a policy of continuous
product improvement and product specifications and component types are subject to change
without notice.
If you, as a user of this manual, have any relevant comments or questions about the CWS4000
or this Manual, your communication with Care Essentials would be welcomed. Our contact
details are located on the first page of this Manual.
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Care Essentials CWS4000 Cocoon Warming System Service Manual
2. OPERATION
2.1. Unit Setup
The CWS4000 may be placed on the floor, mounted on the foot of the bed using the foldout
brackets, or clamped to an IV pole using the IV pole clamp. When using an IV pole, do not
mount the CWS4000 higher than 1 metre or it could tip over. Do not place the CWS4000 ona
bed surface. Note that if the CWS4000 is placed on the floor, increased levels of dust and lint
could reduce filter life.
IV Pole Clamp
maximum
Figure 4 Pole mounting height limit
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Care Essentials CWS4000 Cocoon Warming System Service Manual
F
Output Temperature
Seiection Indicators
|
Symbols
See section 2.4
Fault Alarm Indicator
Standby Indicator Filter Status Indicator
A+
Standby Button
Output temperature
Ambient Temperature
selection buttons
Output Button
Ambient Temperature
Output Indicator
Figure 5 Operator control panel
2.2. Getting Started
Plug the mains cable into a conventional, properly earthed 240 Volt 10 Amp mains power
socket-outlet and switch it on. The green Standby indicator (B) will illuminate and the
CWS4000 will beep when power is connected.
Ensure that air is not prevented from entering the inlet slots at the sides by blankets or other
objects.
Remove the warming blanket from its packaging. Unfold the warming blanket and place it over
the patient. Connect the air delivery hose to the warming blanket by pushing the plastic fitting
into the air inlet port.
2.3. Unit Operation Procedure
Select the desired temperature on the control panel pressing either one of the Output
temperature selection buttons (E) or Ambient Temperature Output Button (C). The
appropriate green or yellow light (D or F) will indicate the selected temperature setting. Another
temperature may be selected at any time. The air temperature surrounding the patient will vary
at each setting, depending upon ambient air temperature and the quality of the insulating
blanket or sheet that is used over the warming blanket. When using the 34°C, 37°C, 40°C, 43°C,
or 46°C temperature settings, place your hand under the warming blanket to confirm that the
CWS4000 is supplying warm air. Place a sheet or blanket over the inflated warming bianket to
maximize the efficiency and minimize the heat loss from the system.
The internal timer will automatically decrease the temperature setting from 46°C to 43°C after 10
minutes. This timer can be reset by momentarily selecting another setting and then re-selecting
46°C.
Switch the unit off by pressing the Standby Button (A). The green Standby indicator (B) will
illuminate when the unit is off.
The unit will automatically switch off in an alarm condition and the green Standby indicator (B)
will illuminate together with the red Fault Alarm indicator (H). In the event the Fault Alarm
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Care Essentials CWS4000 Cocoon Warming System Service Manual
indicator (H) illuminates, disconnect the CWS4000 from the patient and from the mains power
supply and have it serviced by trained personnel.
The Filter Status indicator (G) provides the user with information on remaining filter life. This
indicator is interpreted as follows:
Indication Description
Steady green indicator Filter status normal
Steady orange indicator | Filter life has reached 950 hours
Flashing orange indicator | Filter life has reached 990 hours
Steady red indicator Filter life has exceeded 1000 hours and requires replacing
2.4. Symbols
The following symbols are used on the CWS4000:
个 Attention: consult accompanying documents
Dangerous voltage
A Type BF applied part
16°C - 29°C Ambient operating temperature range, indoor use only
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Care Essentials CWS4000 Cocoon Warming System Service Manual
3. SAFETY PRECAUTIONS
Review the following safety precautions prior to servicing the CWS4000.
3.1. Danger
e Explosive hazard. Do not use in the presence of flammable anaesthetic agents.
e Risk of electric shock. Disconnect mains power before servicing the CWS4000.
3.2. Warning
e Ensure that no direct or indirect contact is made between the patient and the communications
connector located on the rear of the CWS4000.
e The CWS4000 must only be opened or serviced by qualified personnel such as certified
biomedical electronics technicians or certified clinical engineers familiar with repair practices
for servicing medical devices, and in accordance with the Service Manual. Damage to the
CWS4000 or malfunction could otherwise result.
e Ensure the CWS4000 is subjected to the specified routine electrical safety and performance
inspections.
e Inthe event of excess fluid contact with the CWS4000 it is recommended that the unit be
disconnected from the mains power supply and checked by qualified personnel.
e Use only in accordance with Operator Manual instructions.
3.3. Caution
e Operate the CWS4000 only in the specified supply voltage range and environmental
conditions and as detailed in Section 11 below.
ο When using an IV pole, do not mount the CWS4000 higher than 1 metre or it could tip over.
e The 46°C setting is not recommended for patients who are non-responsive or with impaired
circulation.
e It is not recommended that the unit be operated after the filter has exceeded the specified
life period.
3.4. Electromagnetic Interference
The CWS4000 has been designed to comply with IEC 601-1-2:2004 (Medical electrical
equipment — Part 1: General requirements for safety. 2. Collateral standard: electromagnetic
compatibility — Requirements and tests) but this does not guarantee that other equipment in the
vicinity will not be affected by the electromagnetic emissions from the CWS4000. Similarly,
other equipment in the vicinity may affect the operation of the CWS4000.
It is recommended that all equipment used near the CWS4000 comply with the relevant
electromagnetic compatibility requirements for that equipment and to check before use that no
interference is evident or disruptive. Increasing the distance between offending devices, and
keeping interconnecting leads as short as possible will help reduce the effect.
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Care Essentials CWS4000 Cocoon Warming System Service Manual
4. PREVENTATIVE MAINTENANCE
4.1. Cleaning
e Clean the CWS4000 control panel, enclosure exterior, and hose with a soft cloth lightly
dampened with a non-staining hospital disinfectant.
e Clean accumulated dirt and lint from the air inlet slots using a vacuum cleaner.
4.2. Electrical Safety Inspection
Care Essentials recommend that the CWS4000 receive regular electrical safety inspections.
Information on the type and frequency of inspections may be obtained from locally published
technical standards.
In Australia, the relevant technical standards are:
e AS3551 Technical management programs for medical devices.
This standard specifies procedures required to develop equipment management programs
for medical devices. Some of these include procedures for acceptance, fault management
and routine testing of medical devices. This standard specifies electrical safety, essential
safety and performance testing.
e AS2500 Guide to the safe use of electricity in patient care.
This standard provides a comprehensive guide to the safe use of electrically operated
equipment used in health care facilities. Measures are detailed to provide and maintain
patient and operator safety, including details of the classes of equipment and electrical
installations to be used for particular medical procedures.
Programmed electrical safety inspections are essential to confirm continued operator and
patient safety. Mandatory, statutory requirements for electrical safety inspections may also
apply.
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Care Essentials CWS4000 Cocoon Warming System Service Manual
4.3. Performance Inspection
Care Essentials recommend that the CWS4000 receive at least an annual performance
inspection to verify CWS4000 functions. The CWS4000 does not require adjustment or
calibration.
Items Required:
e CWS4000 Operator & Service Manuals.
» Digital Thermometer.
STEP PROCEDURE
1 If you have not already done so, read the CWS4000 Operator and Service Manuals.
2 e Place the CWS4000 on a firm, level surface.
e Do not connect the delivery hose to a warming blanket.
e Connect the CWS4000 to mains power.
3 Familiarise yourself with the operation of the CWS4000 by operating the CWS4000 with reference to
the CWS4000 Operator and Service Manuals.
4 The temperature control system is verified as follows:
e Ensure the delivery hose cover is undamaged and that it covers the entire hose.
e Ensure that the environmental conditions are 20°C to 22°C, 30% to 70% relative humidity, non-
condensing.
e Place the digital thermometer sensor in the centre of the delivery hose outlet as shown in
Figure 6.
« Check that the temperature of delivered air stabilises within five (5) minutes following a change in
set temperature.
e Check that the temperature of delivered air corresponds with the set temperature to within +2°C.
e Note that some variation between the set temperature and temperature of delivered air is
possible because of heat loss that occurs in the delivery hose. The magnitude of the heat loss
will depend on the ambient temperature and the degree to which the hose is longitudinally
compressed or extended.
Temperature Sensor
Figure 6 Delivery hose outlet showing temperature sensor position
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