PAXMAN Instructions for Use UK ROW Issue 3 Sept 2019

PAXMAN SCALP COOLER INSTRUCTIONS FOR USE SECTION 2 /

Contents

1. Introduction to scalp cooling 2. Device description 3. Technical Data and Specifications 4. Intended use/indications for use 5. Contraindications/warnings and precautions/side effects 6. Equipment supplied 7. Guide to the system and parts 8. Device handling and safety 9. Quick release couplings 10. Cooling caps information 11. Patient cap size selection 12. System preparation procedure 13. Patient preparation 14. Cap fitting to the patient 15. Treatment stage 1 to stage 3 16. Post-infusion cooling times 17. Temporary disconnection during cooling 18. Completion of scalp cooling 19. Cap removal 20. Cleaning of the Paxman Scalp Cooler and caps/cap storage 21. Correct storage of caps 22. Disposal of damaged or contaminated components 22. Periodic maintenance 23. Coolant Level 24. Material safety and data 25. Training 26. Label Information

1 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

Page

2 3 5 6 7 8 9 10 12 13 14 15 16 17 19 23 24 25 26 27 28 30 31 32 34 35 36

INTRODUCTION TO SCALP COOLING

Hair loss (alopecia) is recognised as one of the most common and distressing side effects of chemotherapy. For their effectiveness in treating cancer, chemotherapy drugs rely on their ability to attack rapidly dividing malignant cells. However, these drugs will also attack healthy hair follicle cells (around 85-90% of which are normally in a state of rapid growth at any one time), causing partial or total atrophy of the hair root. This can result in weakening or fracture of the hair shaft.

1

Preventing or reducing hair loss can result in increased self-confidence and positive attitude in patients - which are widely recognised as beneficial in the fight against cancer. Scalp cooling aims to reduce chemotherapy-induced hair loss by causing constriction of the blood vessels in the scalp, thereby reducing the amount of chemotherapy drugs delivered to the hair follicles. There is also a reduction in the local metabolic rate, which reduces cellular uptake of the drug at the hair follicle. It is important for the effectiveness of this technique that the scalp remains cold during the time that the drugs are at their highest concentration in circulating blood. In a single treatment session the scalp is cooled for a short period before chemotherapy infusion, during infusion and over a specific period following infusion.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 2

DEVICE DESCRIPTION

2

Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling.

The Paxman Scalp Cooling System meets all the requirements for overall design, biocompatibility, and electrical safety. The results of the non-clinical testing confirm the output meets the design inputs and specifications. The following non-clinical testing was performed.

Biocompatibility The system passed biocompatibility testing in accordance with the requirement for ISO 10993-1 and FDA Guidance. Specifically, Cytotoxicity testing per ISO 10993-5, Sensitization testing per ISO 10993-10, and Intracutaneous Reactivity testing per ISO 10993-10.

Electrical Safety Testing The system passed electrical safety testing in accordance with requirements for IEC 60601-1 medical electrical equipment.

Electromagnetic Compatibility The system passed electromagnetic compatibility (EMC) testing to meet requirements for IEC 60601-1-2 medical electrical equipment. There is no known equipment within the intended operational environment of the scalp cooling system that will interfere with, or be affected by the scalp cooling system.

3 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

Warning Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Scalp Cooling System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result

Electrical Safety • The Paxman Scalp Cooling System is a Class 1 Electrical device and must be connected directly to a Protective Earth System. • Extension Leads or Power Strips should NOT be used • Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked as hospital grade. • Only use an appropriately approved power cord for each country of use. • The Plug is the main isolation device. • Isolate the device by removing the plug before working on the device.

DEVICE DESCRIPTION

Cleaning and Disinfection / Shelf-Life The Paxman Scalp Cooler is provided non-sterile. The cleaning and disinfection process has been validated per AAMI TIR12. Usable life of the device of five (5) years and Cooling Cap shelf life of three (3) years.

Storage and Transport Testing Packaging and shipping testing of the device was conducted based on and demonstrated conformance to ISTA standards.

Software Verification and validation testing were conducted on the Paxman Scalp Cooler software per IEC 62304 and FDA Guidance. All tests were completed successfully with respect to stated pass/fail criteria thereby deeming the device and software appropriate for its intended use.

Non-Clinical Performance Testing Non-clinical performance testing was conducted to demonstrate that the device meets all design specification and performance requirements, and the device performs as intended under anticipated conditions of use. This included: • Heat extraction validation testing. • Scalp temperature validation testing. • Performance testing of coolant management. • Leak testing of cooling cap.

Warning Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential enavironment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio- frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 4

TECHNICAL DATA AND SPECIFICATIONS

Weight Refrigeration unit 43kg

3

Caps between 795g and 900g (inc. coolant and cover)

Dimensions H 640mm x W 320mm x D 420mm. Extended height 1650mm

Power supply 100-110V 50Hz, 100-120V 60Hz or 220-240V 50/60Hz single phase 850VA All electrical circuits earthed and protected with fused system All fuses are Bussmann time delay fuses – 10 A at 250 Vac with T-speed

Condition of use Operational

Transport and Storage

Temperature: 10-30°C / 50-86F Atmospheric pressure: 70-106 kPa Relative humidity: 30-75%

Temperature: -25 to 70C / -13 to 158F Atmospheric pressure: 50-106kPa Relative humidity: 10-90%

Temperature control Electronic thermostat with touch screen controller Coolant flow rate and temperature continuously monitored in line

Alarms Visual and audible for: high temperature conditions Loss of coolant flow

Inlet pressure of coolant flow Pressure into cap - 17psi Flow rate of coolant 10-50 ml/s REFRIGERATION - Hermetically sealed unit. CFC-free R134A refrigerant. COOLANT - Orbis C. See data sheet section 10

Device classification CE marked in accordance with annex V of the Medical Devices Directive 93/42/ EEC for a Class IIa Device. Notified Body No. CE 2797. MDSAP 699742.

Safety Standards BS EN 60601-1: 2006 + IEC60601-1-2006 for medical electrical equipment, BS EN 60601-1-2: 2007 + IEC60601-1-2006 electromagnetic compatibility

Electrical Classification Class 1 type BF Product specifications are subject to continued evaluation and improvements and subject to change without prior notification.

5 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

INTENDED USE / INDICATIONS USE

Indication for Use The Paxman Scalp Cooling System is indicated for use to reduce chemotherapyinduced hair loss in cancer patients receiving systemic chemotherapy with alopecia causing chemotherapy agents.

Intended Use

4

The Paxman Scalp Cooling System is intended for use in a professional healthcare facility environment by a suitably qualified healthcare professional or a Paxman certified, trained representative. Patients and users/operators should be aware of the following: • Hair loss is a possible side effect of chemotherapy. • The treatment success rates vary from patient to patient and with different drug regimens being administered. • Patients cannot be guaranteed they will not lose any or all of their hair. • Patients may experience a headache during treatment. • Some patients may experience feeling cold during the treatment. • Some patients may experience feeling light headed after the cooling cap has been removed. • Patients may visit the bathroom during the treatment. Information on the above indications is available for users and patients

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 6

CONTRAINDICATIONS / WARNINGS / SIDE EFFECTS

Contraindications Scalp cooling is contraindicated for:

5

• The subject has an existing history of scalp metastases, or the presence of scalp metastasis is suspected. • Patients with cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, and post-traumatic cold dystrophy. • Scalp metastases have rarely been reported in the literature, but caution regarding their development has been a limitation for the broad-scale application of scalp cooling during chemotherapy. Theoretically, tumour cells that have seeded in the scalp might not receive adequate chemotherapy during hypothermia, thus allowing them to grow at a later date.

NOTE Warnings and precautions concerning specific aspects of the operation of the Paxman Scalp Cooling System are described within the relevant sections of this user manual. *Total 28 patients had 54 adverse events reported: 44 patient-cycle had 46 AADEs and 8 patient-cycle had 8 UADEs. There was no SAE or SADE. All adverse events were grade 1 (n=46) or grade 2 (n=8). For analysis purposes, within ADE and cycle, each patient was counted once, and patients with the same adverse event within a chemotherapy cycle were counted at the highest reported grade.

• Patients with severe liver or renal disease from any etiology who may not be able to metabolize or clear the metabolites of the chemotherapeutic agent. • Patients with hematological malignancies (leukaemia, non-Hodgkin and other generalised lymphomas. •

Patients with imminent skull irradiation.

Warnings and precautions • It cannot be guaranteed that scalp cooling will prevent all patients undergoing chemotherapy from losing any or all of their hair. The success rate of scalp cooling in reducing chemotherapy-induced hair loss varies from patient to patient and according to the chemotherapy regime administered. • Long-term effects of scalp-cooling and scalp metastasis have not been fully studied • The Paxman Scalp Cooling System should only be used by appropriately qualified healthcare professionals who have been trained in the operation of the device.

WARNING

• Do not allow any liquids to be placed on the scalp cooler or near the touch screen controller, including drips from the cooling caps.

Thermal injury due to improper cap fitting or use of device beyond or outside of recommended instruction may result in thermal skin injuries in mild to moderate cases ( grade 1 or 2).

• Avoid use in ambient temperatures of over 30°C/86°F. • Do not touch the side ventilation grills whilst the device is in use. • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Protocol if a patient has a reaction to Chemotherapy whilst Scalp Cooling If a patient has a reaction to the chemotherapy, leave the scalp cooling cap on whilst immediately responding to the reaction with hospital protocol medication. Leave the cap on the patient for the 30 minutes before re challenging the infusion of chemotherapy. Continue with normal scalp cooling protocols once the reaction has been managed. 7 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

CONTRAINDICATIONS / WARNINGS / SIDE EFFECTS

Side effects Known side effects associated with scalp cooling therapy include: • Discomfort due to feeling cold. • Headache. • Light-headedness or dizziness. • Nausea.

EQUIPMENT SUPPLIED Equipment consists of: Single Paxman Scalp Cooling System 1.

Electronically operated refrigeration unit complete with 2m length power cord. 1 set of coolant lines with quick release couplings, covered with insulation and shroud, single adjustable coolant line support arm.

2.

1 x removable cap support.

3. 1 x Accessories box containing: 3 standard cooling caps; 1 x small, 1 x medium and 1 x large* complete with insulation covers and quick release couplings. 4.

1 litre of coolant (top up).

5.

Manual.

6.

Quick Reference Guide.

7.

Patient information leaflets.

6

* It is optional to have any combination of caps

Dual Paxman Scalp Cooling System 1.

Electronically operated refrigeration unit complete with 2m length power cord. 2 sets of coolant lines with quick release couplings, covered with insulation and shroud, single adjustable coolant line support arm.

2.

2 x removable cap support.

3. 1 x Accessories box containing: 4 standard cooling caps; 2 x small, 1 x medium and 1 x large* complete with insulation covers and quick release couplings. 4.

1 litre of coolant (top up).

5.

Manual.

6.

Quick Reference Guide.

7.

Patient information leaflets.

* It is optional to have any combination of caps

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 8

GUIDE TO THE SYSTEM AND PARTS

Fig 1. Coolant line inlet and outlet connections. Fig 2. Coolant line support arm height adjustment. Fig 3. Power switch (illuminates green).

7

9 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

Fig 4. Mains power connection. Fig 5. System touch screen controller - home screen. Fig 6. Coolant top-up point.

Fig 1.

Fig 2.

Fig 3.

Fig 4.

Fig 5.

Fig 6.

DEVICE HANDLING AND SAFETY

Moving the device The Paxman Scalp Cooling System is provided with 4 swivel castors on the base of the refrigeration unit to enable mobility between uses. All castors feature a foot-operated brake lever designed to prevent unwanted movement of the unit during operation.

8

• To activate the brake, use the foot to depress the lever on all sets of castors • To release the brake, use the foot to raise the lever on all sets of castors. • Cap support arms and cap holders must be removed during transportation and the coolant lines coiled safely on top of the device

Warnings and precautions • The Paxman Scalp Cooling System should be lifted using appropriate lifting equipment. • Ensure the brakes are engaged before switching on the Paxman Scalp Cooling System. • When moving the Paxman Scalp Cooling System, always push it from the rear. • Always disconnect the power cable, before moving the Paxman Scalp Cooling System. • During operation, ensure the Paxman Scalp Cooling System gives easy access to the power lead or mains plug. • Exercise care when moving the Paxman Scalp Cooling System over uneven floors or surfaces with obstructions, undulations, ramps or slopes. A slow manoeuvre is recommended. • Do not move the Paxman Scalp Cooling System using the support arm or cap holders. • Ensure the Paxman Scalp Cooler is always kept upright

Device Safety Standards The Paxman Scalp Cooling System has been tested and complies with British Standard EN60601-1-2006 general requirements for safety for Medical Electrical Equipment. The Paxman Scalp Cooling System has been tested and complies with British Standard EN60601-2:2007 for EMC emissions of Medical Electrical Equipment. Applied parts classification: Type BF.

Touch screen controller care • Do not allow liquids to come into contact with the touchscreen. • Lightly wipe the surface with absorbent cotton or other soft material. Always wipe horizontally or vertically and not in a circle. • Immediately wipe off water drops to prevent damage to the touchscreen. • When using the touchscreen controller press gently, use of excessive pressure may damage the touchscreen.

Overcooling It is extremely unlikely that overcooling can occur due to the inherent design of the device. The refrigeration system and coolant are designed so that the coolant cannot cool below -10°C.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 10

DEVICE HANDLING AND SAFETY

Visual Warnings • The coolant temperature in the Paxman Scalp Cooing system is continuously monitored. • If the temperature is observed to be 5°C/41°F above the set point the Status Symbols will show the exclamation symbol ! Fig 7. and the text will read ‘High Temp’. • The Status Symbol will be green and show a tick Fig 8. if the coolant temperature is below the temperature which is 5°C/41°F above the set point and sufficient flow is detected. This status symbol can also be seen in Fig 16.

Fig 7.

Fig 8.

Insufficient flow warning • The coolant flow rate in the Cooling Cap is continuously monitored. • Visual and audible signals are employed to alert the user if the flow of the coolant becomes obstructed during the scalp cooling treatment. • Check if the coolant line has become obstructed/kinked anywhere as this could affect the flow rate. • Disconnect and reconnect the couplings following the procedure in section 10 if the coolant line does not appear to be trapped. • If the fault persists, please contact the service provider.

11 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

QUICK RELEASE COUPLINGS

The system is designed for ease of use when connecting and disconnecting caps and coolant lines. The system incorporates simple to operate, quick release couplings. The design of the couplings is such that no spillage of coolant will occur.

1

2

9 3

Fig 9.

• W  hen connecting the couplings, the male and female connectors should be held with one in each hand, and simply pushed firmly together to connect as shown in Fig 9. A click will be heard when the couplings are successfully connected.

1

2

3

Fig 10.

• W  hen disconnecting the couplings, simply hold the couplings in both hands and press the white release button as shown in Fig 10. The couplings will spring apart. Continue to pull the couplings apart to complete the disconnect procedure.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 12

COOLING CAP INFORMATION

Patients’ heads vary enormously in shape and size. We have developed a number of different sized caps to accommodate these varying sizes.

10

SMALL

MEDIUM

LARGE

Each silicone cap has a serial number on the cap which can also be used to identify the size of the cap as the first letter(s) of this serial number will be either S, M, or L depending on the size of the cap. Fig 11. The caps are made from medical grade soft silicone. They are light in weight but flexible and strong. The silicone caps are supplied with a neoprene cover. The purpose of this cover is to absorb condensation from the external surface of the cap during use and prevent it from running down the back of patients’ necks. The neoprene cover also acts as an excellent insulator helping with the efficiency of the cooling cap. The bungee cord and chin strap also ensure a snug, tight fit of the cooling cap. The cap covers are colour coordinated for size via the Paxman logo as shown in Fig 12.

Fig 11.

Fig 12.

13 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

PATIENT CAP SIZE SELECTION

Below are listed the key points in ensuring patients are wearing the correct sized cooling cap to help avoid any patchy areas of hair loss and bald spots following scalp cooling treatment. Cap measuring and fitting • It is recommended to allow time for the pre-consultation appointment prior to the commencement of chemotherapy treatment for the fitting of the correct cap size.

11

• Selection of cap size should always be performed with the cap cover removed as shown in Fig 13.

There are 3 key areas that we are looking for and provide you with a 3 point check list when measuring a patient for a cap; 1. Ensure the CAP IS NOT TOO SMALL - It is important that the top of the cap is touching the crown of the patient’s head to avoid crown hair loss. If any amount of force is required to push the cap down on the head then this is an indication that the cap is too small. This could be both painful and the cap could rise up during treatment. 2. HAIRLINE - The cap should cover the whole of the hairline from the front to the back. NB: It is not imperative that the section in front of the ears is covered, see Fig 13.

CAUTION Good all-over contact of the cap with the scalp is essential, any gaps should be eliminated for a successful outcome.

3. Ensure the CAP IS NOT TOO BIG - If the cap is too large you will be able to put two hands inside the back of the cap or in some cases an entire fist. A further indication that a cap is too large is if the cap wobbles about when placed on the head.

INFORMATION

A medium (M) inner silicone cap and a small (S) outer cap cover should be used for any patient considered to be in between the small and medium cap sizes.

The following are indicative of use of an incorrect cap size:

NB: Please note that is acceptable to be able to place a single hand inside the back of the cap, as this does not indicate a cap being too big. The bungee cords will reduce this gap when activated and tightened.

Crown hair loss: CAP TOO SMALL: USE A LARGER CAP.

Hair loss from the back of the head: CAP TOO BIG: USE A SMALLER CAP.

Fig 13.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 14

SYSTEM PREPARATION PROCEDURE

The following checks should be performed before switching on the Paxman Scalp Cooling System:

12

Check the power cable is firmly inserted into the back of the machine. Check the plug is inserted into a wall socket and the socket is SWITCHED ON.

Switch on the Power Fig 14.

INFORMATION It will take approximately 30 minutes for the Paxman Scalp Cooler to cool down to the operating temperature

Fig 14.

• Switch on the system by pressing the Power switch located at the rear of the machine the switch will illuminate green. • After 15 seconds the touchscreen display will show the startup screen shown in Fig 15. • The refrigeration system will begin cooling the coolant which can take up to 30 minutes. During this time the engineering screen is accessible for fault diagnosis. • Once the coolant has reached operating temperature the system will move onto the main screen in Fig 16.

Software Version • The touch screen will show the ‘Software Version’ in the start up screen shown in Fig 15.

Fig 15.

15 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

Fig 16.

PATIENT PREPARATION

• It is recommended to perform any required cannulation of patients prior to the commencement of scalp cooling since vasoconstriction caused by scalp cooling can impair venous access. • Place a towel around the patient’s shoulders. • Lightly dampen the patients’ hair using lukewarm water. • Apply a small amount of conditioner to the dampened hair.

13

• Comb the patient’s dampened hair back using a wide tooth comb or fingers so that the patient’s front hairline is visible. This is especially important for patients with fringes. • If an elasticated headband is an available position below each ear and on the forehead to create a barrier between the cap and the patient’s skin. This will reduce the discomfort.

INFORMATION If patients have long hair you do not need to wet the full length of the hair, just the hair covering the scalp area. It is recommended to use a low alkaline or organic conditioner.

Paxman Shampoo and Conditioner are available from our online shop.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 16

CAP FITTING TO THE PATIENT

Option 1: Cap complete with Cap Cover

Cap cover application • Pinch together the edges of the silicone cap Fig 17.

14

• Insert the pinched cap inside the cap cover Fig 18. • Pull the silicone cap sides outwards to fill the cap cover Fig 19. • Pull the cap cover up over the silicone cap so that the cover fully covers the external surface of the silicone cap Fig 20. • Ensure that there is a snug fit between the cap cover and the silicone cap. Fig 21-22.

NOTE Please note that all the standard protocol of patient preparation should be carried out before fitting the cap. It is also important to still utilise the headband or medical gauze with this cap to prevent direct contact between the silicone cap and bare skin.

Fig 17.

Fig 18.

Fig 19.

Fig 20.

Fig 21.

Fig 22.

INFORMATION

Cap fitting to the patient (including cover)

The coolant lines join the cooling cap at the back of the silicone cooling cap.

Please note that all the standard protocols of patient preparation should be carried out before fitting the cap. It is also important to still utilize the headband or medical gauze with this cap to prevent direct contact between the silicone cap and bare skin.

The Paxman logo is in line with the front of the cap cover. The minimum temperature of the cap is -3.5C or 25.7F.

• Lift the front part of the cap cover up so that the silicone cap is visible. • Fit the cap to the patient’s head whilst standing directly in front of them to ensure the cap is on straight. Align the front of the silicone cap with the hairline and around the ears Fig 23. • Replace the cap cover rim once you are happy with the cap position Fig 24. • Fully tighten the chin strap to set the cap in position Fig 25. • Pull tight on the bungee cord at the back of the cap Fig 26. and lock in place utilizing the bungee cord toggle Fig 27. • Loosen off the chin strap to a more comfortable setting Fig 28. • Connect the Cap to the Paxman System.

17 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

CAP FITTING TO THE PATIENT

Option 2:

Fitting the cap excluding the cap cover. Please note that all the standard protocols of patient preparation should be carried out before fitting the cap. It is also important to still utilize the headband or medical gauze with this cap to prevent direct contact between the silicone cap and bare skin. • Fit the required inner silicone cap to the patients head. Line the front of the silicon cap up with the hairline and around the ears Fig 29.

Fig 23.

Fig 24.

Fig 25.

Fig 26.

Fig 27.

Fig 28.

Fig 29.

Fig 30.

Fig 31.

Fig 32.

• Turn the outer cap cover inside out Fig 30. • Place the inside out cap cover on top of the patients head and silicone cap placing your hand on to hold in place Fig 31. • Roll down the cap cover ensuring all the inner silicone cap is totally covered Fig 32 & 24. • Fully tighten the chin strap to set the cap in position Fig 25. • Pull tight on the bungee cord at the back of the cap Fig 26. and lock in place utilizing the bungee cord toggle Fig 27. • Loosen off the chin strap to a more comfortable setting Fig 28. • Connect the Cap to the Paxman System.

Additional Cap Fitting Tips Starting at the front of the cap cover pull the bungee cords at each side out and back one row at a time.

A.

B.

Once the final cords are pulled tight and the toggle tightened, cross the cords over the toggle at the back of the cap cover to secure in place.

C.

D.

INSTRUCTION FOR USE ROW UK ISSUE 3 09/19 / 18

THE TREATMENT STAGE 1 TO STAGE 3

When the cap has been fitted correctly and connected to the system the patient is ready to commence scalp cooling treatment.

15

Choose required treatment type from the options below. Option 1 Standard treatment. Stage 1-3 (pre cooling, infusion, post cooling).

Option 2 WARNING Before commencing scalp cooling the Paxman Scalp Cooling System should be positioned with the castor brakes engaged.

COOLING STAGES STAGE 1 Pre-Infusion STAGE 2 Infusion STAGE 3 Post Infusion

INFORMATION Should a patient need to stop scalp cooling for any reason please press button.

19 / INSTRUCTION FOR USE ROW UK ISSUE 3 09/19

Stage 1-2 (pre infusion cooling, infusion cooling only). When the system is being used for pre and infusion cooling.

Option 3 Post infusion cooling stage 3 only. When the system is only being used for post infusion cooling.