Instructions for Use
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MODEL PSC-1
INSTRUCTIONS FOR USE
BEFORE OPERATING THE PAXMAN SCALP COOLING SYSTEM, IT IS IMPORTANT THAT THIS MANUAL BE FULLY READ AND UNDERSTOOD BY ALL OPERATORS OF THE SYSTEM.
CONTENTS Section
Contents
Page
1 2 3 4 5 6 7 8 9 10 11 12
Introduction Equipment Supplied Controls and Indicators Device Handling and Safety System Operation Cooling Cap Assembly Patient Preparation and Procedures for Scalp Cooling System Safety Features Alarm Conditions/Fault Finding General Periodic Maintenance Recommendations Disinfecting and Sterilisation Materials Safety Data Sheets Contact Addresses and Telephone/Fax Numbers
4 5 6 7 10 12 16 17 18 20 21 24
INTRODUCTION
DEVICE FUNCTION AND DESCRIPTION Hair loss is undoubtedly one of the most distressing side effects of chemotherapy. Preventing or reducing alopecia by scalp cooling can result in a patient’s increased self confidence and positive attitude - widely recognised as beneficial in the fight against cancer. The Paxman Scalp Cooler is a device which is offered to selected cancer patients receiving cytotoxic chemotherapy to help prevent or reduce hair loss. The system uses a small refrigeration unit that circulates a coolant through an insulated cooling cap. The scalp is cooled by placing a cap onto the patient’s head, which remains in place for the duration of the treatment. The Paxman Scalp Cooler comprises of a powerful refrigerated cooling system which rapidly reduces the temperature of a liquid coolant to a pre-set temperature. When this temperature has been reached, electronic sensors monitor and control the coolant between -5°C and -6°C. The coolant is pumped, at low pressure, through a scalp cooling cap. The scalp temperature is reduced to an optimum level. The device is simple to operate and is safe for the patient.
INDICATIONS Patients and users/operators should be aware of the following: t )BJSMPTTJTBQPTTJCMFTJEFFòFDUPGDIFNPUIFSBQZ t 5IFUSFBUNFOUTVDDFTTSBUFTWBSZGSPNQBUJFOUUPQBUJFOUBOEXJUIEJòFSFOUESVHSFHJNFOT being administered. t 1BUJFOUTDBOOPUCFHVBSBOUFFEUIFZXJMMOPUMPTFBOZPSBMMPGUIFJSIBJS t 1BUJFOUTNBZFYQFSJFODFBIFBEBDIFEVSJOHUSFBUNFOU t 4PNFQBUJFOUTNBZFYQFSJFODFGFFMJOHDPMEEVSJOHUIFUSFBUNFOU t 4PNFQBUJFOUTNBZFYQFSJFODFGFFMJOHMJHIUIFBEFEBGUFSUIFDPPMJOHDBQIBTCFFOSFNPWFE t 1BUJFOUTNBZWJTJUUIFCBUISPPNEVSJOHUIFUSFBUNFOU Information on the above indications is available for users and patients
CONTRA-INDICATION t t t t t t
3
)BFNBUPMPHJDBMNBMJHOBODJFT MFVLBFNJB OPO)PEHLJOTBOEPUIFSHFOFSBMJTFEMZNQIPNBT $PMEBMMFSHZ $PMEBHHMVUJOJOT .BOJGFTUTDBMQNFUBTUBTFT *NNJOFOUCPOFNBSSPXBCMBUJPODIFNPUIFSBQZ *NNJOFOUTLVMMJSSBEJBUJPO
IFU PSC-2 Issue 4 20.08.2007
SECTION 1
1. EQUIPMENT SUPPLIED WITH THE PSC-2 Equipment Consists of: 1.1
Electronically operated refrigeration unit c/w power cable
1.2
TFUTPGDPPMBOUMJOFTXJUIRVJDLSFMFBTFDPVQMJOHT DPWFSFEXJUIOFPQSFOFTISPVE
1.3
Four standard cooling caps. 1 small, 2 medium and 1 large
$PNQMFUFXJUIJOTVMBUJPODPWFSTBOERVJDLSFMFBTFDPVQMJOHT*
1.4
Adjustable coolant line support arm
1.5
MJUSFPGDPPMBOU UPQVQ
1.6
1MBTUJDTUPSBHFCJO 6,POMZ
1.7
Instructions for use manual
1.8
Guidance for use notes.
1.9
Recommended cooling periods information sheets.
1.10 Patient information leaflets 1.11 Technical Data and specification file.
* It is optional to have any combination of caps.
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SECTION 2
2. CONTROLS INDICATORS AND CONNECTIONS 2.1
Power cable connection.
2.2
Fuses.
2.3
Coolant line support arm - height adjustment.
2.4
Coolant filling point.
2.5
Coolant level gauge.
2.6
Coolant line connections.
2.7
Re-circulation ports.
2.8
Temperature controller.
2.9
1PXFSTXJUDI JMMVNJOBUFTHSFFO
2.10 1VNQTXJUDI JMMVNJOBUFTHSFFO 2.11 HI-Temp alarm / return coolant temp/flow indicator. 2.2
2.3
2.4
2.5 2.6
2.1 2.7
2.8
5
2.9
2.10
2.11
IFU PSC-2 Issue 4 20.08.2007
SECTION 3
3. DEVICE HANDLING AND SAFETY 3.1 DEVICE HANDLING CAUTION If the device has to be lifted it should be performed by two people using the lifting handles provided. 8IFOEFWJDFJTJOVTFFOTVSFCSBLFTPOUIFGSPOUDBTUPSTBSFFOHBHFE When manoeuvring the device, the mains cable must first be removed. Pushing the device can be performed GSPNFJUIFSUIFGSPOUPSUIFCBDLPGUIFEFWJDF EXTREME CAUTIONNVTUCFUBLFOXIJMTUNPWJOHUIFEFWJDFPWFS uneven floors or surfaces with obstructions, undulations, ramps or slopes. A slow manoeuvre is recommended.
WARNING Do not manoeuvre the device with the support arm. Tipping can cause the device to become unstable.
3.2 DEVICE SAFETY The device has been tested and complies with British Standard BS EN ISO 60601-1-1990 including amendements A1, A2, A11, A12 and A13 general requirements for safety for Medical Electrical Equipment. Our certificate number is DUR22211/AC/00. Classification: Class 1 Type BF
WARNING: Potential effects of electromagnetic radiation The device has been tested for EMC emissions and meets with the standard BS EN ISO 60601-2:2002 for a Group 1 Class A device. Our certificate number is C/00/096. Awareness however should be made to the potential of electromagnetic radiation and advice to reduce the potential of this occurring. We would typically advice users to consider increasing the distance between potentially offending equipment, switching off non-critical equipment and consider shortening connecting leads.
3.3 APPLIED PARTS The scalp cooling caps are applied parts and are covered under Applied Parts classification ‘Type BF’ for QSPUFDUJPOBHBJOTUFMFDUSJDBMTIPDL
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SECTION 4
4.1 SYSTEM OPERATION SYSTEM PREPARATION PROCEDURE QSJPSUPDPNNFODJOHTDBMQDPPMJOH 4.1.1 With the PSC-2, two caps can be selected and cooled simultaneously. Alternatively if only one patient is receiving scalp cooling, the spare cooling line must be connected into the recirculation port. This will ensure the TZTUFNDJSDVMBUFTDPPMBOUDPOUJOVPVTMZBOEXPSLTUPJUTNPTUPQUJNVNMFWFM 4.1.2 $IFDLDPPMBOUMFWFMFOTVSFJUJTBUPQFSBUJOHMFWFMUPQVQJGOFDFTTBSZ 4.1.3 Plug the unit into mains power supply ensuring both of the cable ends are fully inserted. 4.1.4 Press POWER ON, switch will illuminate GREEN. Temperature controller LCD will illuminate and in a few seconds the coolant temperature will be indicated. 4.1.5 Press PUMP ON switch. Switch will illuminate GREEN. The Hi Temp/Alarm LCD will illuminate indicating the return coolant temperature. The LCD will also alternate between the temperature display and a high temperature warning ‘HI’. An audible warning buzzer will also sound. This should be muted by pressing the mute button. The buzzer will be muted but HI will continue to flash until the pre-set temperature is reached. The controller will re-set automatically. When the coolant return temperature is below 5.1°C the ‘HI’ temperature warning will stop flashing. 4.1.65IFVOJUXJMMDPOUJOVFUPSVOVOUJMUIFQSFTFUUFNQFSBUVSFJTBDIJFWFE5IJTXJMMUBLFBQQSPYJNBUFMZISUP 11/2 hrs dependent on the ambient room temperature it is operating in. MUTE Note - The system can be switched on without the pump operating. This will reduce the temperature PGUIFDPPMBOUJOUIFIPMEJOHUBOL CVUUIFTZTUFNXJMMOPUCFSFBEZGPSVTFBTUIFDPPMBOUJOUIF coolant lines and caps will not be at the correct temperature and will require cooling prior to use. 8"3/*/(%0/0501&3"5&5)&4:45&.8*5)065$00-"/5*/5)&5"/, THIS WILL DAMAGE THE CIRCULATOR PUMP
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4.2 OBSERVE t The noise of the refrigeration system running. t Small airflow from front of unit. t Temperature readouts slowly decreasing. t 5IFDBQJTTUBSUJOHUPHFUDPME JOTJEF BGUFSTFWFSBMNJOVUFTPGPQFSBUJPO APPROXIMATE TIMES FOR SYSTEM TO REACH OPERATING TEMPERATURE IN DIFFERENT ROOM TEMPERATURES Ambient Room Temperature Up to 18°C 18°C - 22°C 22°C - 26°C #05)8*5)$"1 4 "55"$)&%
Time 1 hr to 1 hr 10 mins 1 hr 10 mins to 1 hr 20 mins 1 hr 20 mins to 1 hr 40 mins
4.3 AFTER 15 MINUTES 4.3.1 Temperature read outs should be slowly decreasing. 4.3.2 Cooling caps should be feeling cold.
4.4 READY FOR USE 5IFSFGSJHFSBUJPOVOJUXJMMBVUPNBUJDBMMZTUPQ TXJUDIFTBOE-$%TSFNBJOJMMVNJOBUFE XIFOUIFQSFTFUPQFSBUJOH temperature has reached -6°C. The system has now reached its operating temperature. The temperature on the controller will start to rise slowly. When approximately - 5°C is reached the refrigeration unit will automatically start running again. The system has been designed to cycle on and off continually whilst in use. 5IFUFNQFSBUVSFXJMMSJTFBOEGBMMCFUXFFOBQQSPYJNBUFMZ¡$UP¡$ 5IJTXJMMWBSZTMJHIUMZEFQFOEBOUPOSPPN UFNQ 5IFFRVJQNFOUJTSFBEZGPSVTFBOETDBMQDPPMJOHDBODPNNFODF 4.4.1 The HI Temp/Alarm LCD should be indicating a temperature between approx -4°C and +4°C. This will be dependent on room temperatures and if there are one or two caps connected to the system. NOTE - If the coolant lines have been connected into the recirc ports, follow 4.5 before commencing scalp cooling for a second patient.
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4.5 UNCOOLED CAPS - NEW PATIENT/NEW CAP To use an uncooled cap for either a new patient or to change to a cap which has not been cooled, it will be OFDFTTBSZUPBMMPXBGVSUIFSDPPMJOHQFSJPEPGNJOVUFT EFQFOEFOUPOSPPNBNCJFOUUFNQFSBUVSFUP BMMPXUIFDBQUPSFBDIPQFSBUJOHUFNQFSBUVSF CFGPSFUIFDBQDBOCFVTFE8IFOBOFXDBQJTDPOOFDUFE CPUI temperature controllers will show an increase in temperature. This is normal. The HI Temp alarm will be activated if the temperature rises above 5.1°C. Press the mute if warning buzzer is activated. The temperature will soon GBMMBOEUIF)*WJTVBMXBSOJOHXJMMTUPQøBTIJOH$IFDLUPFOTVSFDBQJTCFDPNJOHDPMEFS8IFOUIFUFNQFSBUVSF DPOUSPMMFSSFBDIFTBQQSPY¡$ OPU¡$ BOEXIFOUIF)*WJTVBMXBSOJOHTUPQTøBTIJOH UIFDBQXJMMCFSFBEZ for use.
4.6 PATIENT CHANGEOVER Patients can begin and terminate scalp cooling at any time independently of each other. The system has been designed to allow any patient to commence and terminate cooling without effecting the other patient being treated. When a patient terminates scalp cooling, they should be disconnected and the coolant lines re-connected to the recirculation ports. The cap should be cleaned and made ready for use for the next patient. A cap can be re-connected at any time.
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IFU PSC-2 Issue 4 20.08.2007
SECTION 5
5. COOLING CAP ASSEMBLY 5.1 SCALP COOLING CAP The cap assembly has 3 distinct components: t"DPMPVSDPEFETJMJDPOFDBQ3FE 4NBMM 1VSQMF .FEJVN #MVF -BSHF tAdjustable insulating cover, colour coded to match cap t2VJDLSFMFBTFDPVQMJOHT.BMF 4NBMM
5.2 CONNECTING AND DISCONNECTING COOLING $"148*5)26*$,3&-&"4&$061-*/(4 IMPORTANT - ALWAYS SWITCH OFF PUMP BEFORE CONNECTING OR DISCONNECTING 5.2.1 Before connection or disconnection of couplings, it will be necessary to pull apart the velcro neoprene cover to expose the male and female couplings. NOTE: There is no left or right coupling, connecting to either is possible. 5.2.2$POOFDUJPO TFFQBHF 5PDPOOFDUUIFDPPMJOHDBQTUPUIFDPPMBOUMJOFT QVTIUIFNBMFDPVQMJOHJOUP UIFGFNBMFDPVQMJOH BMJUUMFQSFTTVSFOFFETUPCFBQQMJFE BDMJDLXJMMCFIFBSEXIFODPVQMJOHTBSFFOHBHFE 5.2.3%JTDPOOFDUJOH TFFQBHF )PMEUIFNBMFBOEGFNBMFDPVQMJOHTJOFBDIIBOE BTTIPXOPOQBHF Press the release button on the female coupling which will cause the male coupling to partially eject from the female coupling by approximately 10mm. Gently pull the couplings apart, a little force may be needed. NOTE - Do not pull apart by holding the silicone tubing. NOTE - It is recommended to wear protective gloves when handling the coolant. NOTE - Do not forget to turn on the pump after connection.
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IFU PSC-2 Issue 4 20.08.2007
TO CONNECT COUPLINGS
MALE COUPLING FEMALE COUPLING
Hold female and male Couplings in each hand
Push couplings together -JTUFOGPSDMJDL
Repeat procedure for other coupling
TO DISCONNECT COUPLINGS RELEASE BUTTON
5BLFDPVQMJOHJOFBDIIBOEBOE press release button
Couplings will partially disengage
Gently pull apart.
NOTE: Do not pull apart by holding silicon tube
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IFU PSC-2 Issue 4 20.08.2007
SECTION 6
6.1 PATIENT PREPARATION AND PROCEDURE FOR SCALP COOLING Prior to commencement of scalp cooling procedures, it is advised that the scalp cooling time applicable to the drug regimen being administered is assessed and recorded. This can be obtained from our recommended cooling periods information sheets.
6.2 NEW PATIENTS Before scalp cooling can commence, it will be necessary to select a cap which fits the patient. Patients head shape, ear position, hair lines and hair quantity will affect the fitting. The selected cap should not be overtight or too loose. It is essential to have good scalp contact for most effective cooling. A cap which is too tight will cause discomfort and may lead to patients discontinuing with the procedure. 6.2.1 New patients should be offered all the caps to determine the best fit. This procedure should be VOEFSUBLFOBTTPPOBTQSBDUJDBMUPBMMPXUIFQSFDPPMJOHPGUIFDBQXIJDINBZCFSFRVJSFE BOEUPQSFWFOUBOZ delay in commencement of scalp cooling. Caps which have not been previously connected to the system and SFRVJSFDPPMJOHXJMMUBLFCFUXFFOBOENJOVUFTUPSFBDIPQFSBUJOHUFNQFSBUVSF TFFTFDUJPO 6.2.28IFOUIFDPSSFDUTJ[FPGDBQIBTCFFOTFMFDUFEBOEQSFDPPMFEUIFTZTUFNJTSFBEZGPSVTF$)&$, INSIDE OF CAP IS COLD. It is recommended that a record of the patient’s cap size is made for future reference. 6.2.3 Before scalp cooling commences with a NEW patient, it is important to explain the procedure fully. The patient should understand that scalp cooling can be discontinued at any time and that it will not jeopardise the chemotherapy treatment. 6.2.4 It is recommended that the Paxman Cooler patient information leaflet is offered to patients who are having scalp cooling for the first time.
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IFU PSC-2 Issue 4 20.08.2007
6.3 PROCEDURE HAIR TYPES The effectiveness of scalp cooling is dependent on having a good scalp to cap contact. Although the cap is very efficient in cooling the scalp, the patient’s hair acts as an insulation barrier. It is recommended to minimize the insulation effect of hair and allow for better cap to scalp contact by wetting and applying a ph neutral or natural IFSCBMUZQFIBJSDPOEJUJPOFSUPUIFQBUJFOUTIBJS'PSQBUJFOUTXJUIUIJDLBOEBGSPDBSJCCFBOIBJSXIPEPOPUVTF this option it is recommended that the pre-cooling time is increased by 10-15 minutes to allow sufficient cooling of the scalp prior to drug infusion. 6.3.1 5IFQBUJFOUTIPVMECFTFBUFEQSJPSUPUIFöUUJOHPGUIFDPPMJOHDBQ"TLQBUJFOUUPBTTJTUJOQMBDJOHUIFDBQ on their head, ensuring the cap cover is fitted and the trailing feed lines are positioned down the left side of the patient. Ensure the cap fits correctly and the cap cover is not rolled up inside the cap. 6.3.2 The patient’s ears are normally outside the cap but if necessary can be positioned inside the cap if this is more comfortable for the patient. If ears are inside the cap ensure they are protected from the cold. 6.3.3 Where necessary cover forehead/brow and ears with cotton wool or gauze. Try to position the cap to just CFMPXUIFIBJSMJOFPOUIFQBUJFOUTGPSFIFBE "EKVTUUIFDBQUPFOTVSFJUEPFTOPUDPWFSUIFGPSFIFBEBTUIJT DPVMEDBVTFIFBEBDIF 5PBTTJTUJODPSSFDUMZQPTJUJPOJOHUIFDBQUVSOVQUIFDBQDPWFSUPFYQPTFUIFQSPöMFPG the cap. 6.3.48IFODPSSFDUMZQPTJUJPOFEUVSOEPXOUIFDBQDPWFSBOEQVMMEPXOUIFDIJOTUSBQ"TLUIFQBUJFOUUPQMBDF in a comfortable position on chin. Note: Hold the cap at the front when positioning the chin strap to avoid pulling the cap forward and onto the patient’s forehead. 6.3.5 Gently pull down on each strap to tighten the cap onto the patient’s scalp, Caution: Do not over tighten as this may cause discomfort. 6.3.6 "EKVTUIFJHIUPGTVQQPSUBSNUPSFNPWFBOZESBHFòFDUPGDPPMBOUMJOFT TFFTFDUJPO 1MBDFDPPMBOU MJOFTJOQPTJUJPOUPBWPJELJOLJOHPGDPPMBOUMJOFT . 6.3.7 Ensure patient is comfortable. The cap should not be over tight but also not too loose. If in doubt, try another size of cap. 6.3.8$IFDLDPPMBOUMJOFTBSFOPULJOLFEPSUXJTUFE 6.3.9 &OTVSFJOMFUBOEPVUMFUUVCFTPOUIFDBQBSFOPULJOLFEPSUXJTUFE 6.3.10 Pre-cooling of the patients scalp can now commence.
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IFU PSC-2 Issue 4 20.08.2007
6.4 PRE-COOLING IMPORTANT - IT IS RECOMMENDED TO CANULATE PATIENTS PRIOR TO SCALP COOLING TO .*/*.*4&5)&3*4,0'10037&/064"$$&44 PLEASE REFER TO THE RECOMMENDED COOLING TIMES TABLE PROVIDED WITH YOUR GUIDANCE FOR USE. 6.4.1$IFDLUIFQSFDPPMJOHUJNF"NJOJNVNPGNJOVUFTJTSFRVJSFEGPSQSFDPPMJOHUIFQBUJFOUTTDBMQ QSJPSUPJOGVTJPOPGDIFNPUIFSBQZESVHT 4FFUIFSFDPNNFOEFEDPPMJOHUJNFTEBUBTIFFUT 0UIFSQBUJFOU preparations can now commence prior to infusion. 6.4.2&OTVSFQBUJFOUJTDPNGPSUBCMFQJMMPXTBOECMBOLFUTTIPVMECFPòFSFEGPSFYUSBDPNGPSU 6.4.3 Reassure patient that although there is an initial cold feeling, this will become much less noticeable after 10-15 minutes. To avoid distress it is advisable for first time users to be comforted and distracted during this initial cooling period.
6.5 COMMENCE DRUG ADMINISTRATION NOTE: Drug administartion should not commence before minimum recommended pre cooling time has elapsed. "GUFSBENJOJTUSBUJPOPGUIFBMPQFDJBDBVTJOHDIFNPUIFSBQZESVHT DIFDLUIFUJNFBOEDBMDVMBUFBQPTUDPPMJOHUJNF for completion of scalp cooling. Inform the patient of the length of time of cooling and the actual time the cap can be removed. This will allow patients to remove the cap by themselves in the event that the nursing staff are unavailable to assist in the removal of the cap. PLEASE REFER TO THE RECOMMENDED COOLING TIMES TABLE PROVIDED
6.6 TEMPORARY DISCONNECTION FROM THE SYSTEM SWITCH OFF PUMP BEFORE DISCONNECTION 6.6.1 Patients can be disconnected from the system for a temporary period without effecting the treatment, a maximum of 5 minutes is recommended. This will allow patients to visit the bathroom, or move as required by the medical staff. Disconnection procedures must be followed. NOTE: COOLING CAP MUST REMAIN ON PATIENTS SCALP DURING TEMPORARY DISCONNECTION FROM THE SYSTEM. 6.6.2 Whenever disconnection is required the pump must be switched off. Dependent on the number of patients and caps connected to the system will determine the action required. If two patients are connected the coolant lines of the disconnected patient must be connected to the recirculation ports and the pump switched on whilst the patient is absent. 6.6.3 When both patients require to be disconnected together both sets of coolant lines must be connected to the recirculation ports and the pump remains switched on. On return of the first patient the coolant lines are reconnected to the cap and the second patient’s coolant lines remain connected to the recirculation ports. Switch on the pump to recommence cooling. When the second patient returns switch off pump, disconnect coolant lines from recirculation ports, re-connect to the cooling cap and switch on pump to recommence cooling. 6.6.4 If the system is in use for a single patient with the spare coolant lines connected into the recirculation ports, switch off the pump, disconnect coolant lines from the cap and connect to the re-circulation port and switch pump on. On return reconnect to the cooling cap and switch on the pump to recommence cooling. 14
IFU PSC-2 Issue 4 20.08.2007
6.7 ALARMS Patients should be advised what to do in the event of hearing the Hi-Temp Alarm. They should immediately draw it to the attention of a member of the nursing staff. Long delays can result in the treatment being ineffective. /05&*GUIFBMBSNTPVOET DIFDLUIFNBMFBOEGFNBMFDPVQMJOHTIBWFCFFODPSSFDUMZDPOOFDUFEBTUIJT is the usual cause for alarm activation.
6.8 COMPLETION OF TREATMENT 6.8.1 On completion of scalp cooling treatment the cap can be removed. 6.8.2 Release chin straps by pulling up on the toggle fasteners. 6.8.3"TTJTUUIFQBUJFOUUPSFNPWFDPPMJOHDBQVTJOHCPUIIBOETQVTIJOHVQBOECBDLGSPNUIFGSPOU 6.8.4 Important - Try to encourage patient to rest if desired before attempting to move in case dizziness is experienced. 6.8.5 Disconnect cap from coolant lines ensuring pump is first switched off. Connect coolant lines into recirculation ports if applicable and switch on pump to continue cooling of 2nd patient. 6.8.63FNPWFUIFDBQDPWFSUIFOSJOTFBOEXJQFUIFJOTJEFPGDBQ5IJTDBOCFEPOFJOUIFTJOLBGUFSEJTDPOOFDUJOH the cap from the coolant lines. The cap is ready for immediate use on the next patient.
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IFU PSC-2 Issue 4 20.08.2007
SECTION 7
7. SYSTEM SAFETY FEATURES 7.1 TEMPERATURE CONTROLLER The Temperature Controller is factory set to display a normal operating temperature between -7°C and -4°C. The LCD temperature read-out shows the coolant temperature in degrees Celsius and has a low temperature alarm. An alarm will sound and the LCD will flash low if the coolant reaches the low temperature alarm setting of -14°C. The system has been designed to ensure the temperature does not go below -14°C. Even at this temperature the system will be JOIFSFOUMZTBGFXJUIOPEBOHFSUPQBUJFOUTPSVTFST0UIFSTBGFUZDVUPVUTXJMMQSFWFOUBOZSJTLPGTVQFSDPPMJOH
7.2 HI-TEMP ALARM The LCD temperature read-out gives an indication of coolant temperature on its return from the cooling caps. If the UFNQFSBUVSFSJTFTBCPWF¡$BOBMBSNXJMMTPVOE #V[[FS BOEUFNQFSBUVSFJOEJDBUPSXJMMøBTI)*5IJTDBOCFEVFUP a restriction in the flow of coolant and / or one of the following conditions may apply: t2VJDLSFMFBTFDPVQMJOHTIBWFOPUCFFODPOOFDUFEDPSSFDUMZ t,JOLFEøPXMJOFT t-PXDPPMBOUMFWFM t1VNQGBJMVSF t'VTFEDPOOFDUJPO
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IFU PSC-2 Issue 4 20.08.2007
SECTION 8 8.1 ALARM CONDITIONS/FAULT FINDING/FUSES Fault
Action
8.1.1 Cap not cold
1.$IFDLDPVQMJOHTGVMMZFOHBHFE 2.$PPMBOUMJOFTOPULJOLFE 3. Ensure 2 caps are connected or coolant lines are connected to recirculation port 4.$IFDLQVNQTXJUDIJTPO
8.1.2)*UFNQ"MBSN CV[[FT
1. $IFDLBMMDPVQMJOHTBSFGVMMZFOHBHFE 2. $IFDLJGDBQPSøPXMJOFTBSFLJOLFE 3.$IFDLDPPMBOUMFWFM 4. $IFDLDPPMBOUIBTSFBDIFEDPSSFDUPQFSBUJOH temperature and LCD is between -5°C - -6°C
8.1.3"MMDPOUSPMTXPSLCVUOPDPPMJOH
1. $IFDLDPVQMJOHTGVMMZFOHBHFE 2. $PPMBOUMJOFTOPULJOLFE 3. Ensure 2 caps are connected or coolant lines are connected to recirculation port 4. $IFDLDPPMBOUMFWFMBOEUPQVQJGSFRVJSFE TFFNBJOUFOBODF
8.1.4 Circulator pump fails to operate
1. $IFDLGVTF'
8.1.5 When Mains power is switched on, The compressor does not operate and the green light fails to illuminate
1. $IFDLGVTFJONBJOTQPXFSQMVH 2. $IFDLGVTF'BOE' 3.$IFDLQPXFSQMVHJOCBDLPGVOJUJTGVMMZJOTFSUFE 4. *GBMMBCPWFDIFDL0, $POUBDU4FSWJDF )FMQ%FTL
8.1.6 5FNQFSBUVSFDPOUSPMMFSBMBSNT CV[[FT - pump is switched on
1. Switch off unit 2. $POUBDU4FSWJDF)FMQ%FTL
8.1.7 Hi-temperature alarm controller not illuminated when pump switched on
1. $POUBDU4FSWJDF)FMQ%FTL
8.1.8 Temperature controller not illuminated when main power switch is on
1. $IFDLGVTF' 2. *GBMMBCPWFDIFDL0, $POUBDU4FSWJDF )FMQ%FTL
8.1.9 Temperature controller does not EFDSFBTFJOUFNQFSBUVSFBGUFSNJOT
1.$IFDLGVTFT JGUIFTFBSF0, $POUBDU4FSWJDF)FMQ%FTL
NOTE - THE CHANGING OF FUSES MUST BE CARRIED OUT BY QUALIFIED TECHINCAL PERSONNEL. REMOVE POWER CABLE FROM UNIT BEFORE CHANGING FUSES.
8.2 FUSES F1 - Type F 10amp - Mains Power Live Feed, F2 - Type F 10amp - Coolant Pump F3 - Type F 10amp - Refrigeration Compressor, F4 - Type F 10amp - Mains Power Neutral Feed
4&37*$&)&-1%&4, TELEPHONE NUMBER: 01484 349444 17
IFU PSC-2 Issue 4 20.08.2007
SECTION 9
9.1 GENERAL PERIODIC MAINTENANCE RECOMMENDATIONS t $IFDLDPPMBOUMFWFMUPQVQBTOFDFTTBSZ1PVSDPPMBOUJOUPSFDFQUBDMF'JMMUISPVHIöMMJOHQPJOUUPNBYJNVNMFWFM t $IFDLDPPMJOHDBQTGPSXFBSBOEUFBS$IFDLGPSCVMHFTBOEDSBDLJOHBSPVOEDPVQMJOHT$VUCBDLBOE replace as necessary. t $IFDLDPPMBOUMJOFTGPSXFBSBOEUFBS*UJTBEWJTFEUIBUDPPMBOUMJOFTCFSFQMBDFEFWFSZNPOUIT t ,FFQDBQTDMFBOBOEXBTIBTOFDFTTBSZ t ,FFQGSPOUBOESFBSHSJMMTDMFBSBOEGSFFGSPNEVTU6TFBWBDVVNDMFBOFSUPTVDLPVUBOZCVJMEVQPGEVTUPSEJSU especially on the condenser coil at the rear of the device. t 8BTIDPVQMJOHTXJUIMJRVJEEFUFSHFOUBOEDIFDLUIFZBSFGSFFGSPNPCTUSVDUJPOT t *GDPVQMJOHTCFDPNFTUJDLZVTF.PMZLPUFTJMJDPOMVCSJDBOUUPMVCSJDBUFUIFSVCCFSA0SJOHPOUIFNBMFDPVQMJOH NOTE - IT IS RECOMMENDED THAT WHILST HANDLING COOLANT, SURGICAL GLOVES ARE WORN.
9.2 ANNUAL SERVICING It is recommended that the Paxman Scalp Cooling System is annually serviced. Paxman Coolers can provide a comprehensive annual service and maintenance contract. Information is available upon request.
9.3 IN-HOUSE REPAIRS & SERVICE Component part lists, circuit diagrams, descriptions, instructions and / or information is available to assist USER’s appropriately trained and qualified technical personnel to replace those parts of the EQUIPMENT designated SFQMBDFBCMF&RVJQNFOUSFQBJSTTIPVMEPOMZCFVOEFSUBLFOCZUIFDPNQBOZTBVUIPSJTFESFQSFTFOUBUJWF or other competently trained personnel.
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9.4 RECOMMENDED SPARES t Silicone Caps tCap insulation covers tCouplings male and female tCoolant tCoolant Line Assembly tCable Ties t10 amp fuses t.PMZLPUF4JMJDPOMVCSJDBOU
9.5 COOLING CAP MAINTENANCE 9.5.1 The silicone cooling cap should be cleaned with soap or a mild detergent and warm water after each treatment session. The insulating cap cover should be completely removed before cleaning. The silicone cap should be dried inside and out after cleaning and the cap cover re-fitted. Ensure when refitting the cap cover it is placed on the cap the correct way. 9.5.2 Periodically the cap cover may require cleaning. Remove the cover from the silicone cap prior to cleaning. Cleaning can either be by hand or using a washing machine on a 40˚C cycle wash program. Any standard washing powder or detergent can be used. Leave the cover to dry naturally before re-fitting to the silicone cap. Ensure when refitting the cap cover it is placed on the cap the correct way. 9.5.31FSJPEJDDIFDLTGPSCVMHFT TQMJUT XFBSBOEUFBSBSPVOEDPVQMJOHTTIPVMECFNBEF
9.6 RE-FITTING COUPLINGS The inlet and outlet tubes on the cap do wear from time to time. The worn perished part of the inlet and outlet tubes can be removed and the cap continued to be used. tCarefully cut the plastic fixing cable tie. tPull the connector out of the tube. t$VUCBDLTJMJDPOFUVCFUPSFNPWFXPSOQBSUXJUIBTIBSQLOJGF tInsert coupling into tube. tAttach new plastic fixing cable Tie. t Repeat for other coupling. /PUF8FSFDPNNFOEUIFBCPWFQSPDFEVSFJTVOEFSUBLFOCZBDPNQFUFOUNBJOUFOBODFFOHJOFFS /PUF2VJDLSFMFBTFDPVQMJOHTXJMMCFJOTQFDUFEBOESFöUUFECZBNBJOUFOBODFFOHJOFFSPOUIFBOOVBM TFSWJDFWJTJU POMZJGNBJOUFOBODFDPOUSBDUJTJOGPSDF BOETIPVMEOPUOPSNBMMZIBWFUPCFSFöUUFE )PXFWFS JOUIFVOMJLFMZFWFOUUIFZEP UIFBCPWFQSPDFEVSFNVTUCFGPMMPXFE
9.7 DRAINING COOLING CAPS OF COOLANT tRemove couplings from the inlet and outlet tubes as described in 9.6 above. t6TJOHBMBSHFTVSHJDBMTZSJOHF XJUIPVUOFFEMF JOTFSUJOUPUIFJOMFUPVUMFUUVCF ESBJOPòDPPMBOU tCoolant can be either returned directly to the cooler via the filler point, put into the coolant top up bottle or disposed of in accordance with waste disposal and water authority regulations. tWhen all coolant is removed, the cap should be flushed out with tap water using the syringe. t1SPDFEVSFTIPVMECFQFSGPSNFEPWFSBTJOLBOETVSHJDBMHMPWFTTIPVMECFXPSO
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SECTION 10
DISINFECTION AND STERILISATION 10.1 SILICONE CAP The silicone cap and its accessories are supplied non-sterile and are not subject to disinfection or sterilisation protocols. Should the user hospital deem that the silicone cap and its accessories be contaminated and unfit for continued use then the contaminated silicone cap and its accessories should be removed from use and disposed of by the preferred method of incineration. Before disposal, ensure that the coolant inside the silicone cap is removed by follow the procedure detailed in section 9.7
10.2 REFRIGERATION UNIT The refrigeration unit and its accessories are supplied non-sterile and are not subject to disinfection or sterilisation protocols. Should disinfection or sterilisation of the refrigeration system and its accessories be deemed necessary CZDJSDVNTUBODFTBSJTJOHJOUIFJOEJWJEVBMIPTQJUBM QMFBTFDPOUBDUPVSIFMQEFTLBOEQSPWJEFEFUBJMTPGUIFNFUIPE of disinfection or sterilisation that is to be used. Advice then can be provided as to what effect this may have on the refrigeration system. It is advised that any contaminated coolant line assemblies be replaced and the contaminated coolant line assemblies be disposed of by the preferred method of incineration. Before disposal ensure any coolant is drained from the coolant lines. 'PSGVSUIFSJOGPSNBUJPOBOEBEWJDFQMFBTFDPOUBDUPVS$VTUPNFS)FMQ%FTL
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