Cocoon CWS 4000 User manual

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
WWWWW
Date 02.11.2015
Supersedes: 19.12.2014
Page 1

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 2
CONTENTS
1. OPERATION...........................................................................................................4
1.1. Unit Setup........................................................................................................4
1.2. Getting Started.................................................................................................5
1.3. Unit Operation Procedure ................................................................................5
2. PATIENT WARMING BLANKETS ...........................................................................6
2.1. Cocoon Disposable Patient Warming Blankets................................................6
2.2. Cocoon Reusable Patient Warming Blankets...................................................6
2.3. Practical Issues to Consider When Selecting and Using Blankets....................6
2.4. CWS4000 Operating Mode..............................................................................7
2.5. CWS 4000 Standby Mode................................................................................7
3. SYMBOLS...............................................................................................................8
4. SAFETY PRECAUTIONS......................................................................................10
4.1. Danger...........................................................................................................10
4.2. Contra-indications..........................................................................................10
4.3. Warning.........................................................................................................10
4.4. Caution..........................................................................................................11
4.5. Electromagnetic Interference.........................................................................11
5. PREVENTATIVE MAINTENANCE ........................................................................12
5.1. Cleaning ........................................................................................................12
5.2. Filter Service..................................................................................................12
5.3. Electrical Safety and Performance Inspection................................................12
6. TROUBLESHOOTING...........................................................................................13
6.1. Warming Blanket Will Not Inflate....................................................................13
6.2. Standby Indicator Will Not Light.....................................................................13
6.3. Equipment Repairs ........................................................................................13
7. ACCESSORIES.....................................................................................................13
7.1. Stand.............................................................................................................13
7.2. User Training.................................................................................................13
8.1.............................................................................................................................14
8. WARRANTY..........................................................................................................14
9. RETURNING OF UNIT FOR REPAIR ...................................................................14
9.1. Australia.........................................................................................................14
9.2. Worldwide......................................................................................................14
10. SPECIFICATIONS.................................................................................................15
11. APPROVALS.........................................................................................................16
12. APPENDIX 1. COCOON CWS4000 PRODUCT INFORMATION .........................18
13. APPENDIX 2. COCOON REUSABLE BLANKET WASHING AND FOLDING
INSTRUCTIONS...........................................................................................................20

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 3
INTRODUCTION
This device should only be operated under the guidance/supervision of qualified
medical/nursing personnel or other paramedical staff trained in the use of Convective Patient
Warming Systems.
Intended Use
The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or
normothermic patients for whom induced hyper or hypothermia or localized temperature therapy
is clinically indicated. In addition, the Cocoon Convective Warming System can be used to
provide patient thermal comfort when conditions exist that may cause patients to become too
cold or too warm. The Cocoon Convective Warming System can be used with adult and
pediatric patients.
It is a pre-requisite for all persons using this medical device to understand the information
contained in this Manual. Read and understand this Manual and all precautions prior to
operating the Cocoon Convective Warming System.
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 5.3.
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, 34oC
(93.2ºF), 37oC (98.6ºF), 40oC (104ºF), 43oC (109.4ºF), or 46oC (114.8ºF). When a temperature
of 46oC (114.8ºF) is selected, the setting automatically drops to 43oC (109.4ºF) 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 sides of the CWS4000 and passes through a bacteriological HEPA filter.
The CWS4000 includes a number of over-temperature prevention systems and in a temperature
fault condition it automatically shuts down and signals an alarm. The CWS4000 continuously
monitors system integrity and performance from the time of start-up.
This Manual presents all the relevant operation information for the Care Essentials CWS4000
Cocoon Warming System. This information is intended for the 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.
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

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 4
product improvement. 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.
1. OPERATION
1.1. Unit Setup
The CWS4000 may be placed on the floor, mounted on the bed rails of the bed using the bedrail
hooks, 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 on a bed
surface. Note that if the CWS4000 is placed on the floor, increased levels of dust and lint could
reduce filter life.
Figure 2 IV pole or stand mounted Figure 3 Bed rail mounted
Figure 4 Pole mounting height limit

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 5
Figure 5 Operator control panel
1.2. Getting Started
Plug the mains cable into a conventional, properly earthed 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 CE Marked warming blanket from its packaging. Unfold the warming blanket and
place it over or under the patient as per the blanket instruction. Connect the air delivery hose to
the warming blanket by pushing the plastic fitting into the air inlet port and securing it firmly.
1.3. Unit Operation Procedure
Select the desired temperature on the control panel by pressing the ambient temperature
output button (C) or one of the output temperature selection buttons (E). The appropriate
green or yellow light (D or F) will indicate the selected temperature setting. Another temperature
may be selected at any time. When using 34oC (93.2ºF), 37oC (98.6ºF), 40oC (104ºF), 43oC
(109.4ºF), or 46oC (114.8ºF) temperature settings, place your hand under the warming blanket
to confirm that the CWS4000 is supplying warm air. Placement of a blanket, sheet or drape over
the inflated warming blanket may be undertaken to maximize the efficiency and minimize the
heat loss from the system. When using additional covers it is important to ensure air flow
through the convective warming blanket is not disrupted.
The internal timer will automatically decrease the temperature setting from 46oC (114.8ºF) to
43oC (109.4ºF) after 10 minutes. This timer can be reset by re-selecting the 46oC (114.8ºF)
temperature setting.
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 that the fault alarm
indicator (H) illuminates, disconnect the CWS4000 from the patient and from the mains power
supply and have it serviced by trained personnel.

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 6
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 replacement
2. PATIENT WARMING BLANKETS
Care Essentials manufactures both Cocoon single-use and reusable (available Australia only)
patient warming blankets. Use only patient warming blankets and machines recommended by
Care Essentials. Failure to do so may result in thermal injury.
2.1. Cocoon Disposable Patient Warming Blankets
Features of Cocoon disposable patient warming blankets include:
Warm, soothing, cocooning design.
Single use. This product is not for reuse due to the risk of cross infection.
Universal inlet port ensures hose stays firmly in the blanket.
Latex free.
Full range of blankets. Refer to www.careessentials.com.au for details.
2.2. Cocoon Reusable Patient Warming Blankets
Features of Cocoon reusable patient warming blankets include:
Technically advanced smart fabric.
Antistatic and non-linting.
Oil and water repellent.
Universal air inlet is designed for ease of use and offers a secure fitting to all convective
warming machines.
Cocoon reusable blankets are an environmental friendly alternative to disposable blankets.
Full range of blankets: refer www.careessentials.com.au for details.
This is a reusable product, which should be laundered between patient uses as per the provided
washing instructions with blankets.
Care Essentials will review the blankets, with the intention of removing them from use, two
years following the date of issue.
2.3. Practical Issues to Consider When Selecting and Using Blankets
Select the correct style and size of blanket.
Ensure the CWS4000 delivery hose is attached securely.
Secure the position of the blanket on the patient using tapes and ties.
Place the convective warming blanket directly against the patient’s skin.

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 7
When using additional covers over the patient, e.g. sheets, blankets or drapes, it is
important to ensure air flow through the convective warming blanket is not disrupted.
Inflate the blanket before adding additional covers.
Monitor the temperature setting on the CWS4000.
In the course of temperature monitoring by clinical staff, if the temperature of the patient is
still going down, the CWS4000 should be checked for the performance inspection as per
section 3.3 of the Service Manual.
In case the warming through CWS4000 is not found effective, clinicians should consider an
alternative warming.
2.4. CWS4000 Operating Mode
The temperature of the air delivered to the blanket can be set to one of six settings ambient,
34oC (93.2ºF), 37oC (98.6ºF), 40oC (104ºF), 43oC (109.4ºF), or 46oC (114.8ºF)
Select the desired temperature on the control panel by pressing the ambient temperature output
button or one of the output temperature selection buttons 34oC (93.2ºF), 37oC (98.6ºF), 40oC
(104ºF), 43oC (109.4ºF), or 46oC (114.8ºF ). The CWS 4000 will deliver air within the specific
temperature range given bellow.
Temperature Mode Temperature of Delivered air
34oC 34oC±2oC
37oC 37oC±2oC
40oC 40oC±2oC
43oC 43oC±2oC
46oC 46oC±2oC
Ambient deliver air to the blanket at the ambient temperature of the room.
When the temperature mode selected, CWS4000 starts functioning as follows:
The green light indicator next to the selected temperature illuminates.
Fan motor operates.
Heater activation as per temperature settings except ambient mode, when heater does
not get activated.
Hour meter connected on the main PCB gets activated.
2.5. CWS 4000 Standby Mode
Select the standby button to place the unit in standby mode. When in standby mode, the
following events occur;
Illuminates standby green indicator light.
Turn off heater & fan
Deactivate hour meter
Alarm and fault detection function remains active.

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 8
3. SYMBOLS
The following symbols are used on the Cocoon Convective Warming System:
Follow Operating Instruction
Attention: Refer website or manual
Dangerous voltage
Type BF applied part
Do not free hose
Single patient Use
NON STERILE
The device has not been sterilised
Latex free
Keep Dry

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 9
Date of Manufacture
European Authorized Representative
European Conformity
Protective earth ground
Fuse
Ambient operating temperature range, indoor use only
Storage Conditions
16°C-
29°C
-20°C
55°C

Care Essentials
CWS4000 Cocoon Warming System Operator Manual
QPF 053 Revision Y
Date 02.11.2015
Supersedes: 19.12.2014
Page 10
4. SAFETY PRECAUTIONS
Review the following safety precautions prior to servicing the CWS4000.
4.1. Danger
Explosive hazard. Do not use in the presence of flammable anaesthetic agents.
Risk of electric shock. Disconnect mains power before servicing the CWS4000.
4.2. Contra-indications
The 46 degree Celsius setting is not recommended for patients who are non-responsive or
with impaired circulation.
Device is only to be used by or under the advice of healthcare professionals.
4.3. Warning
To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
Do not apply heat to lower extremities during aortic cross clamping. Thermal injury may
occur if heat is applied to ischemic limbs.

No free hosing –use of the CWS4000 without a compatible convective warming
blanket may cause thermal injury.
Ensure that no direct or indirect contact is made between the patient and the
communications connector located on the rear of the CWS4000.
Do not use other warming devices in conjunction with CWS4000 unless guided by
appropriate qualified clinician.
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.
Ensure the CWS4000 is subjected to the specified routine electrical safety and performance
inspections.
The temperature of the patient should be continuously be monitored at a regular interval.
In the course of temperature monitoring by clinical staff, if the temperature of the patient is
still going down, the CWS4000 should be checked for the performance inspection as per
section 3.3 of the service manual.
In case the warming through CWS4000 is not found effective, senior clinicians should be
informed for an alternative warming.
In the 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.
Use only in accordance with Operator Manual instructions.
Do not position the CWS4000 so that it is difficult to operate the appliance plug and socket.
Do not lay non-porous peach side of the Cocoon blanket touching the patient. Always lay
the porous white side of the Cocoon blanket over or under, touching the patient.
Do not use a Cocoon blanket to transfer or move the patient.