Care Essentials CWS4000 Cocoon Warming System Operator
Contents
1. Care Essentials CWS4000 Cocoon Warming System Operator Manual 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 ae IV Pole Clamp Figure 2 IV pole or stand mounted Figure 3 Bed rail mounted 1m maxi Figure 4 Pole mounting height limit QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 4 Care Essentials CWS4000 Cocoon Warming System Operator Manual F Output Temperature Selection Indicators COCOON CONVECTIVE WARMING SYSTEM Symbols See section 2 4 E Fault Alarm Indicator Standby Indicator Filter Status Indicator A Standby Button c O E Ambient Temperature Output temperature Output Button selection buttons D Ambient Temperature Output Indicato2. QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 10 Care Essentials CWS4000 Cocoon Warming System Operator Manual s Do not allow the patient to lie on the warming unit hose or allow the hose directly contact the patient s skin during patients warming thermal injury may result e No modification of this equipment is allowed e The unit will automatically switch off in an alarm condition and the green standby indicator will illuminate together with the red fault alarm indicator on the front key pad e To avoid injury do not use the CWS4000 patient warming system for therapy unless the CWS4000 system is free from mechanical damage mounted securely or safely placed ona hard surface e Do not use material of good conductivity such as water gel and other similar substances underneath the blanket If used it will lead to decrease of effectiveness of warming 4 4 Caution e Operate the CWS4000 only in the specified supply voltage range as detailed in Section 11 below e When using an IV pole do not mount the CWS4000 higher than 1 metre or it could tip over e Use only with 5 wheel base IV pole with atleast 3 wheels with breaking padels and maximum height of 1m e Monitor the temperature and cutaneous response of patients who are incapable of reacting communicating and or who are without a sense of feeling according to institutional protocol Monitor the patient s vital signs regularly Adjust air temperature or
3. 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 46 C 114 8 F to 43 C 109 4 F after 10 minutes This timer can be reset by re selecting the 46 C 114 8 F temperature setting Switch the unit off by pressing the standby button A The green standby indicator B will illuminate when the unit is off QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 5 Care Essentials CWS4000 Cocoon Warming System Operator Manual 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 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 bo
4. EI Essential care before during and after surgery Convective Warming Machine CARE ESSENTIALS 0000 Postal Address 25 27 Slevin Street Nth Geelong Vic 3215 Australia Telephone 613 5277 1455 Facsimile 613 5277 1411 Copyright 2007 Care Essentials Pty Ltd CWS 4000 OPERATOR MANUAL Priory Analysts Ltd The Atrium Park Street West C Luton LU1 3BE United Kingdom 0805 Care Essentials CWS4000 Cocoon Warming System Operator Manual CONTENTS E a lt 2 lt T ARON HT 4 Tele Unit SOUP it eisai hl eter atnart E E EE e 4 1 2 Getting SIAC A he mit ages eee ea area etna eee tei on needa nen Meet en tees 5 1 3 Unit Operation Procedure sss esse eee eee 5 2 PATIENT WARMING BLANKETS see eee 6 2 1 Cocoon Disposable Patient Warming Blankets eee eee eee 6 2 2 Cocoon Reusable Patient Warming Blankets ccccccceeeseeeeeeeeeeeeeeeeenaees 6 2 3 Practical Issues to Consider When Selecting and Using Blankets 6 2 4 CWS4000 Operating Mode esse eee 7 2 5 CWS 4000 Standby Mode 7 E amc 026 H H 8 SAFETY PRECAUTIONS cis coteetts aide inva Ait E teeta alee 10 ale Dangerren eo ee a eee er eee eee 10 4 2 OOMPAINGIGAONS setccc eet cnccatatet E E S 10 4 3 NWA ae casi a leusea te aE a ea akiges ak Geel E EE EE aA 10 BA MEANS Meee te shel Oe ak a Mach se E eae Mane ee 11 4 5 Electromagnetic Interference sss 11 B PREVENTATIVE MAINTENANCE eee 12 Salie Glea
5. discontinue therapy when the therapeutic goal is reached or if vital sign instability occurs Notify physician of vital sign instability immediately s Do not leave paediatric patients including infants unattended during therapy s It is not recommended that the unit be operated with a filter which has exceeded the specified life period e Federal US law restricts this device to sale by or on the order of a physician e To reduce the risks associated with environment contamination follow applicable regulations when disposing this device along with accessories or any of its electronic components 4 5 Electromagnetic Interference The CWS4000 has been designed to comply with IEC 60601 1 3rd Edition 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 QPF 053 Revision V Date
6. 000 delivery hose is attached securely QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 6 Care Essentials CWS4000 Cocoon Warming System Operator Manual e Secure the position of the blanket on the patient using tapes and ties e Place the convective warming blanket directly against the patient s skin e 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 e Inflate the blanket before adding additional covers e Monitor the temperature setting on the CWS4000 e Inthe 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 e Incase 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 34 C 93 2 F 37 C 98 6 F 40 C 104 F 43 C 109 4 F or 46 C 114 8 F Select the desired temperature on the control panel by pressing the ambient temperature output button or one of the output temperature selection buttons 34 C 93 2 F 37 C 98 6 F 40 C 104 F 43 C 109 4 F or 46 C 114 8 F The CWS 4000 will deliver air within the specific temperature range give
7. 02 04 2014 Supersedes 11 03 2014 Page 11 Care Essentials CWS4000 Cocoon Warming System Operator Manual 5 PREVENTATIVE MAINTENANCE 5 1 Cleaning s Do not immerse the device or hose while cleaning Moisture will damage the components and thermal injury may occur s Do not use a dripping wet cloth to clean the device Moisture may seep into the electrical contacts and damage the components s Do not use alcohol or other solvents to clean the labels of the device strong solvents may damage the labels and other plastic parts e Disconnect the device from the power source before cleaning e Clean the CWS4000 control panel enclosure exterior and hose with a soft cloth lightly dampened with a non staining hospital disinfectant or mild detergent or antimicrobial spray e Dry with separate soft cloth e Clean accumulated dirt and lint from the air inlet slots using a vacuum cleaner 5 2 Filter Service Only qualified service personnel may change filters Refer to the CWS4000 Service Manual for instructions on replacing the filter Under normal use replace the HEPA filter inside the CWS4000 every 1000 operating hours or 12 months whichever occurs first The filter status indicator G will warn of the need for filter replacement 5 3 Electrical Safety and Performance Inspection Care Essentials recommend that the CWS4000 receive regular electrical safety inspections Information on the type and frequency of inspections may be ob
8. LESHOOTING 6 1 Warming Blanket Will Not Inflate e Make sure the CWS4000 is plugged in to an energized mains power socket outlet e Check both ends of the delivery hose for proper connection e Check the delivery hose and warming blanket inlet for kinks e Check that there are no obstructions to the air inlet slots e Check the warming blanket for damage If air is flowing from the hose try another warming blanket e Request qualified service personnel check for a clogged or dirty filter e Check for fault alarm 6 2 Standby Indicator Will Not Light Extremely high storage temperatures such as those found motor cars on hot summer days can cause the temperature limit thermostats in the CWS4000 to actuate Should this occur the standby indicator B will fail to light when the CWS4000 is connected to mains power If this occurs simply wait for the CWS4000 to cool down and eventually the thermostats will automatically reset and the standby indicator B will light Request qualified service personnel check for blown mains power fuses 6 3 Equipment Repairs Repairs to the CWS4000 should be performed by qualified personnel such as certified biomedical electronics technicians or clinical engineers familiar with repair practices for servicing medical devices and in accordance with the CWS4000 Service Manual Damage to the CWS4000 or malfunction may otherwise result 7 ACCESSORIES 7 1 Stand An optional stand for the CWS4000 is av
9. NSI AAMI ES60601 1 2005 C1 A2 CSA C22 2 No 60601 1 2008 IEC EN 60601 1 2005 2006 C1 C2 80601 2 35 Heating Blankets Pads and Mattresses 2009 QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 18 Care Essentials CWS4000 Cocoon Warming System Operator Manual 13 APPENDIX 1 COCOON CWS4000 PRODUCT INFORMATION Model Care Essentials Pty Ltd Cocoon CWS4000 220V 240V 110V 120V Where Marketed Australia Asia Middle East Africa Europe North America South America etc FDA Clearance No 510K being applied for CE Mark Yes CE 0805 Configuration Mobile portable pole or bed mounted trolley Applications Operating Theatre Intensive Critical Care Area Recovery Emergency Trauma Ward Controls Keypad Display Type LED Visual Indicators Function Indicators Standby Filter Status Fault Indicator six temperature settings plus ambient setting Ambient to 46 degrees Celsius Line Power VAC 110 120 VAC or 220 240VAC Warmer Power W 1100 watts maximum Blanket Full range of disposable and reusable types Hose Length 1 8 metres Temp Settings Ambient 34 37 40 43 46 degrees Celsius 93 2 98 6 104 109 4 114 8 degrees Fahrenheit Safety Thermostats 53 degrees Celsius 3 degrees Celsius 127 4 degrees Fahrenheit 5 4 degrees Fahrenheit Automatic Overheat Shutoff Yes Alarm Conditions High temperature safety c
10. ailable 7 2 User Training In service training is available from Care Essentials or a nominated distributor QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 13 Care Essentials CWS4000 Cocoon Warming System Operator Manual 8 COMMINGLING WARMING UNITS AND BLANKETS Commingling refers to the use of Cocoon warming blankets with other manufacturer s Class II B Convective Warming Systems Care Essentials recommends that you consider the following recommendations and warnings when commingling 8 1 _Commingling Recommendations and instructions Use warming units that delivers air at a regulated temperature through a delivery hose Use warming units with audible and visual over temperature alarms Ensure that bends in the delivery hose are minimised when in use Excessive bends in the delivery hose may affect the temperature performance Ensure that the end of the delivery hose of the warming machine is properly inserted into an entry inlet of a Cocoon blanket and secured tightly with the ties like tying shoe laces For Reusable blankets ensure that the end of the delivery hose is well inserted into the blue ribbed hose inlet Inflate the blanket and ensure that there is no leakage of warm air To compare the Cocoon Convective Warming System with other manufacturers please refer to the CWS 4000 Product Information chart in Appendix 1 8 2 Commingling Warnings Ensure the connection of the delivery hose and blanke
11. ded by appropriate qualified clinician 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 The temperature of the patient should be continuously be monitored at a regular interval e Inthe 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 e Incase the warming through CWS4000 is not found effective senior clinicians should be informed for an alternative warming 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 s Do not position the CWS4000 so that it is difficult to operate the appliance plug and socket s 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 e Do not use a Cocoon blanket to transfer or move the patient
12. duct is laundered Plastic bags are clear so product labels can be clearly viewed and included manufacturers name and contact details Folding instructions are provided below for laundries to ensure blankets are folded correctly when re packaged QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 21 Care Essentials CWS4000 Cocoon Warming System Operator Manual F Cee INSTRUCTIONS d Blanket in 715 again G Fold Blanket in R Right to Left Fold Blanket in 1 2 again G Fold Blanket in fs Right to Left Fold Blanket in 2 Left to Rigt Label should show on top right corner a a ae aret 7 Te lt R o OL J Fos bottom meen 7 1 3 up Ek eree a Fold Blanket in k n d C L 1 2 Right to Left Fold bottom G Fold Blanket in Ys up 6 Erg 1 3 Right to Left L Fold Blanket in 2 Left to Right Laina Label should show on top right comer 6 Fold Blanket in 1 2 Right to Left zee 5 Fold Blanket in 2 Left to Righ Label should show on top right comer Fold Blanket in 2 Fold Blanket in O iit hy Right to Left 2 Fold Eiee inYeand ge 2 Fold Blanket in 2 Left to Righ tuck straps in G Label should show on top right corner o Lay Blanket flat al Fold Blanket Fold i Fold PF Fold E in 2 i bottom to top in Yo wR in leagain Label should show on Sterilisation Reusable blankets can be sterilized in accordance
13. exible 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 93 2 F 37 C 98 6 F 40 C 104 F 43 C 109 4 F or 46 C 114 8 F When a temperature of 46 C 114 8 F is selected the setting automatically drops to 43 C 109 4 F 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 QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 3
14. flammable anaesthetic mixtures with air oxygen nitrous oxide Surface disinfection is possible using a cloth moistened with a mild Method of disinfection a ae S non staining disinfectant solution PERFORMANCE Ambient 34 2 C 93 2 3 6 F 37 2 C 98 6 3 6 F 40 2 C 104 3 6 F Temperature settings indicate the average air 43 42 C 109 4 3 6 F temperature at the end of the delivery hose 46 2 C 114 8 3 6 F Note The air temperature around the patient is affected by the ambient air temperature the warming blanket type and the use of an insulating blanket placed on top of the warming blanket Recommended operating environment is 16 C 60 8 F to 25 C 77 F Temperature accuracy of delivered air except About 2 C 3 62F with delivery hose cover for the ambient temperature setting Not specified without delivery hose cover Environmental conditions required to achieve 16 C 60 8 F to 25 C 77 F 30 to 70 relative humidity non the specified temperature accuracy condensing maximum altitude of 2000m QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 16 Care Essentials CWS4000 Cocoon Warming System Operator Manual Time required to attain the specified temperature accuracy of delivered air following a change in temperature setting including temperature rise from 23 2 C to 37 C SAFETY SYSTEMS Either of two independent 53 C 127 4 F self reset
15. ision V Date 02 04 2014 Supersedes 11 03 2014 Page 17 Care Essentials CWS4000 Cocoon Warming System Operator Manual Care Essentials Medical Electrical Equipment Part 1 General requirements for safety for CWS 4000 220V 240V Medical Electrical Equipment Part 1 General requirements for safety Section 2 Collateral Standard Electromagnetic Compatibility Requirements and tests for CWS 4000 220V 240V IEC 60601 1 2007 IEC 60601 1 2 2007 UL International New Zealand 21 Tarndale Grove Albany Auckland 0632 New Zealand T 649 414 9580 W ul com Medical Electrical Equipment Part 1 General requirements for safety Part A Collateral Standard Electromagnetic Compatibility Requirements and tests for CWS 4000 110V 120V Particular Standard IEC 80601 2 35 Heating Blankets Pads and Mattresses 2009 _ IEC 60601 3rd Edition Affiliated ANSI AAMI ES60601 1 2005 C1 A2 CSA C22 2 No 60601 1 2008 IEC EN 60601 1 2005 2006 C1 C2 80601 2 35 Heating Blankets Pads and Mattresses 2009 UL International New Zealand 21 Tarndale Grove Albany Auckland 0632 New Zealand T 649 414 9580 W ul com Full Safety Evaluation including UL Classification CUL Classification Informative Test Report for CWS 4000 110V 120V Particular Standard IEC 80601 2 35 Heating Blankets Pads and Mattresses 2009 _ IEC 60601 3rd Edition Affiliated A
16. n bellow Temperature Mode Temperature of Delivered air 34 C 34 C 2 C 37 C 37 C 2 C 40 C 40 C 2 C 43 C 43 C 2 C 46 C 46 C 2 C Ambient deliver air to the blanket at the ambient temperature of the room When the temperature mode selected CWS4000 starts functioning as follows e The green light indicator next to the selected temperature illuminates e Fan motor operates e Heater activation as per temperature settings except ambient mode when heater does not get activated e 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 e lluminates standby green indicator light e Turn off heater amp fan e Deactivate hour meter e Alarm and fault detection function remains active QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 7 Care Essentials CWS4000 Cocoon Warming System Operator Manual 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 09 Se NON STERILE The device has not been sterilised Latex free D Keep Dry P QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 8 Care Essentials CWS4000 Cocoon Warming System Ope
17. nings a e aeons Sacred eae tac daca te caddie ceeded Cate acne ee 12 B25 PIPERS e cc connie ean sano aee AE ass ethers land N cite sete 12 5 3 Electrical Safety and Performance Inspection eee eee eee eee 12 6 TROUBLESHOOTING iid serge daisaer taeae a eaaa aa aa aa a eaaa Tiai 13 6 1 Warming Blanket Will Not lnfiate s sese 13 6 2 Standby Indicator Will Not ght sss eee eee 13 6 3 EQUIPMENT Repalls actus acnceenters once ei tar aguseieare e E tare tea eee 13 Po IO GESSORIES TTT 13 Polis 1 r le Te ATETA AAR EEE AT AEE AE tees barteie TEE TE SIETE 13 7 2 User Training esenea ee eh ed a phe REER E ERR 13 8 COMMINGLING WARMING UNITS AND BLANKETS ceeeeeeeeeeeeeeteeeeeee 14 8 1 Commingling Recommendations and instructions ssseeseeeeeeeeeeeeeees 14 8 2 COMMINGIING WarnlNGS seis sce hoe ceaescdsceet receieesecd geal sede tpensed ones cede cquevedetoeaecntes 14 S WARRANT a E e a e E 15 10 RETURNING OF UNIT FOR REPAIR sss sees eee 15 aO Sa ISTERI EE EEEE E E E E E E E E 15 WOES UL elese Ue rea a E E 15 11 SPE CF OAT O N O e e TT Re THK path EA EEA A 16 12 1 22 PROVA R D 17 13 APPENDIX 1 COCOON CWS4000 PRODUCT 1INEORMATION xxe 19 14 APPENDIX 2 COCOON REUSABLE BLANKET WASHING AND FOLDING IIS TRUO T ON S gee ters eae Sec aN adsl Jae dice ate dieu ware dudes degen on 21 QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 2 Care Essentials CWS4000 Cocoon Warming System Ope
18. or consumables filters hose covers power cords or accessory blankets 10 RETURNING OF UNIT FOR REPAIR 10 1 Australia Call Customer Service 61 3 5277 1455 or write to queries careessentials com au to request a Return for Repair The Cocoon CWS 4000 must be cleaned and disinfected by wiping over with Chlorhexidine 0 5 in Alcohol 70 solution prior to return to Care Essentials The Cocoon CWS 4000 must be packaged with suitable packaging to protect the machine in transit Preferably the Cocoon carton and foam packaging as supplied with the machine Apply the shipping label addressed to Care Essentials Pty Ltd 10 2 Worldwide Contact your local distributor supplier agent for any warranty repair replacement or parts requirements QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 15 Care Essentials CWS4000 Cocoon Warming System Operator Manual 11 SPECIFICATIONS ELECTRICAL 220 240 VAC 50 60Hz Rated input 110 120 VAC 50 60 Hz Supply Power 1100 Watts Maximum 2 x 6 3 Amp 250V Time Lag T 5x20mm 220 240 VAC 2 x HBC 10 Amp 250V Time Lag T 5x20mm 110 120 VAC 1000 Watt heating element 45 Watt 230 V 46 Watts 115 V m 5 Meets UL 60601 1 3 edition and IEC 60601 1 3 Ed requirements Degree of protection against ingress of liquid Degree of safety in the presence of flammable anaesthetic mixtures with air oxygen nitrous oxide Not designed for use in the presence of
19. r 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 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 Refer to Section 8 below for commingling information relating to the use of Cocoon warming blankets with other manufacturer s warming units 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 34 C 93 2 F 37 C 98 6 F 40 C 104 F 43 C 109 4 F or 46 C 114 8 F 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
20. rator Manual 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 re re O oO 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 fl
21. rator Manual mi Date of Manufacture rer European Authorized Representative C European Conformity m 5 Protective earth ground Fuse Ambient operating temperature range indoor use only Storage Conditions QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 9 Care Essentials CWS4000 Cocoon Warming System Operator Manual 4 SAFETY PRECAUTIONS Review the following safety precautions prior to servicing the CWS4000 4 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 4 2 Contra indications e The 46 degree Celsius setting is not recommended for patients who are non responsive or with impaired circulation e Device is only to be used by or under the advice of healthcare professionals 4 3 Warning e To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth s Do not apply heat to lower extremities during aortic cross clamping Thermal injury may occur if heat is applied to ischemic limbs U free hosing use of the CWS4000 without a compatible convective warming blanket may cause thermal injury e Ensure that no direct or indirect contact is made between the patient and the communications connector located on the rear of the CWS4000 s Do not use other warming devices in conjunction with CWS4000 unless gui
22. t is secure and that air is not escaping Consider individual manufacturer s recommendations and warnings when commingling Only use Convective warming machines that have passed safety and electrical testing and approved by CE or FDA Temperature of patients should be monitored by authorised clinicians at regular intervals QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 14 Care Essentials CWS4000 Cocoon Warming System Operator Manual 9 WARRANTY The CWS4000 is warranted free of defects in material and workmanship under normal use and operation for a period of one year under the terms and conditions of the Care Essentials warranty in place at time of purchase During the warranty period Care Essentials will repair or replace at its sole option free of charge any defective parts or products returned with prior authorization prepaid to Care Essentials Consumable items such as filters are excluded The full warranty is available from Care Essentials upon request This warranty does not cover products abused misused or altered outside the factory There are no obligations on the part of Care Essentials for consequential damages arising out of or in connection with the use or performance of the product Care Essentials disclaims all implied warranties including but not limited to the implied warranties of merchantability and of fitness for a particular purpose This warranty does not cover the following accessories
23. tained from locally published technical standards In Australia the relevant technical standards are AS NZS 3551 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 AS NZS 2500 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 Care Essentials also recommends that the CWS4000 receive at least an annual performance inspection as described in the CWS4000 Service Manual As a minimum electrical safety inspection performance inspection and temperature limit thermostat test should be performed annually QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 12 Care Essentials CWS4000 Cocoon Warming System Operator Manual 6 TROUB
24. th 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 e Warm soothing cocooning design e Single use This product is not for reuse due to the risk of cross infection e Universal inlet port ensures hose stays firmly in the blanket e 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 e Technically advanced smart fabric e Antistatic and non linting e Oil and water repellent e Universal air inlet is designed for ease of use and offers a secure fitting to all convective warming machines e 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 e Select the correct style and size of blanket e Ensure the CWS4
25. ting thermostats removes power from the CWS4000 if the delivered air exceeds a preset limit temperature About 2 5 minutes depending on the blanket models Dual temperature limit thermostats A 98 C 208 42F thermal fuse Continuous temperature monitoring guarantees that the temperature of the delivered air maintains its specified accuracy Heater temperature limit devices Temperature limit alarm Continuous self monitoring by the control system ensures that it always functions predictably PHYSICAL 29 cm x 22 cm x 40 cm 6 Kilograms Flame Retardant ABS PC Plastic Bacteriological HEPA filter 1000 hours Dimensions Weight Enclosure Filter type Life orage conditions 20 C to 55 C 4 F to 131 F A tightly engaged blanket with the hose can withstand over 20N force Hose engagement with blanket 12 APPROVALS The CWS4000 has achieved the following medical device approvals Certifying Body Title Standard Wakefield Laboratories Report No 21977 Medical Electrical Equipment Part 1 General requirements for safety for CWS 4000 220V 240V IEC 60601 1 1988 Amendments 1 and 2 AS NZS 3200 1 0 1998 EMC Technologies Report No M050325 Medical Electrical Equipment Part 1 General requirements for safety Section 2 Collateral Standard Electromagnetic Compatibility Requirements and tests for CWS 4000 220V 240V IEC 60601 1 2 2004 QPF 053 Rev
26. ut out fuse visual and audible Noise Level lt 50dB Warm Up Time About 2 5 minutes Air Flow 38 CFM Filtration System Yes HEPA Filtration 0 2 U QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 19 Care Essentials CWS4000 Cocoon Warming System Operator Manual HxWxD 40cm x 29cm x 22cm Weight 6 kg Warranty 2 years Delivery Time 0 3 weeks Other Specifications Heater Element thermal fuse test port through windows Hyper terminal communications program QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 20 Care Essentials CWS4000 Cocoon Warming System Operator Manual 14 APPENDIX 2 COCOON REUSABLE BLANKET WASHING AND FOLDING INSTRUCTIONS Care Essentials recommends the following Cocoon reusable blanket washing instructions to laundries Washing Instructions Loading Instructions Machines should be loaded to no more than 60 of their capacity to reduce friction to the fabric which will reduce the longevity of the blanket Cold rinse wash at 60 degrees C for 10 minutes using a blended non ionic surfactant pack detergent at a PH of 10 to 10 5 followed by 6 rinses and then adjust PH to 5 to 6 Tumble Drying Tumble drying should be carried out in a reduced capacity to ensure complete drying of the blankets Folding and Packaging Sealable plastic bags are provided free of charge to the laundry for packaging each time pro
27. with the sterilizing performance requirements detailed in AS 4187 QPF 053 Revision V Date 02 04 2014 Supersedes 11 03 2014 Page 22
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