ORBIS II Instructions for Use Issue 8 June 2019

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ORBIS II SCALP COOLER INSTRUCTIONS FOR USE Contents 

1. Introduction to scalp cooling 2. Device description 3. Intended use/indications for use 4. Contraindications/warnings and precautions/side effects 5. Equipment supplied 6. Guide to the system and parts 7. Device handling and safety 8. Quick release couplings 9. Cooling caps information 10. Patient cap size selection 11. System preparation procedure 12. Patient Preparation 13. Cap fitting to the patient 14. Pre-infusion scalp cooling 15. Post-infusion cooling 16. Temporary disconnection during cooling 17. Completion of post-infusion scalp cooling 18. Cap removal 19. Cap and cover cleaning/cap storage 20. Disposal of damaged or contaminated components 21. Periodic maintenance 22. The in-built help function 23. Material safety and data 24. Training

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INTRODUCTION TO SCALP COOLING

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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. 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. The user has the option of beginning the pre-infusion scalp cooling with fitting a warm cap or a pre-cooled cap to the scalp. This decision can be made upon personal preferences. It is important to note that there are subtle differences between the procedures which should be followed when the user is starting with a warm cap compared to a pre-cooled cap and therefore care should be taken to ensure that the correct section of this user manual is being referred to in each case. When the user begins the treatment session wearing a warm cap the cap cools down whilst fitted to the scalp which increases the amount of time it takes for the scalp to cool down. Consequently, a slightly longer pre-infusion scalp cooling duration is recommended for treatment sessions in which a warm cap is initially fitted to the user. Although not proven, it is expected that the success of the treatment is not affected by whether the cooling treatment commences with the fitting of a warm cap or a pre-cooled cap, if the correct recommended procedure is followed.

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DEVICE DESCRIPTION

The Orbis II Scalp Cooler is a compact, mobile refrigeration unit that has been tested to IEC 60601:2006 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.

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INTENDED USE / INDICATIONS FOR USE

The Orbis II Scalp Cooler is indicated for use to reduce chemotherapy-induced hair loss in cancer patients receiving systemic chemotherapy with alopecia causing chemotherapy agents.

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The Orbis II Scalp Cooler is intended for use by appropriately qualified healthcare professionals who have been trained in correct operation of the device by a representative of Paxman. 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

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CONTRAINDICATIONS / WARNINGS / SIDE EFFECTS

Contraindications • Haematological malignancies (leukaemia, non Hodgkins and other generalised lymphomas)

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• Cold allergy • Cold agglutinins • Manifest scalp metastases • Imminent bone marrow ablation chemotherapy • 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. • The Orbis II Scalp Cooler should only be used by appropriately qualified healthcare professionals who have been trained in operation of the device.

NOTE NOTE: warnings and precautions concerning specific aspects of the operation of the Orbis II Scalp Cooler are described within the relevant sections of this user manual.

•  DO NOT ALLOW ANY LIQUIDS TO BE PLACED ON THE SCALP COOLER OR NEAR THE TOUCH SCREEN CONTROLLER, INCLUDING THE COOLING CAPS. •  AVOID USE IN AMBIENT TEMPERATURES OF OVER 30°C/86°F.

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

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EQUIPMENT SUPPLIED

Equipment consists of:

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1. Electronically operated refrigeration unit complete with power cable. 2 sets of coolant lines with quick release couplings, covered with insulation and neoprene shroud, single adjustable coolant line support arm, 1 x release aid 2. 1 x Accessories box containing: 4 standard cooling caps; 1 x small, 1 x medium and 1 x large* complete with insulation covers and quick release couplings 3. 2.5 litre coolant for initial fill of Orbis II 4. 1 litre of coolant (top up) 5. Manual 6. Quick Reference Guide 7. Patient information leaflets 8. Filling jug and funnel * It is optional to have any combination of caps

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GUIDE TO THE SYSTEM AND PARTS

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

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4. Pump switch (illuminates green) 5. Mains power connection 6. System touch screen controller – home screen 7. Coolant filling point 8. Coolant sight glass 9. Coolant level line Further information can be found in the Technical Description.

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DEVICE HANDLING AND SAFETY

Moving the device

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The Orbis II Scalp Cooler 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. • To activate the brake, use the foot to depress the lever on both front sets of castors • To release the brake, use the foot to raise the lever on both front sets of castors. • Cap support arms must be removed during transportation and the coolant lines coiled safely on top of the device

Warnings and precautions • If the Orbis II Scalp Cooler has to be lifted, it should only be lifted by two people, using the lifting handles provided • Ensure the brakes are engaged before switching on the Orbis II Scalp Cooler

INFORMATION Each time the device is switched on the Status Symbols will remain red and the accompanying text will read “NOT READY” until the set point temperature is reached. The status symbols will not turn green when the coolant is 5°C/41°F above the set point during this initial cooling down process.

• When moving the Orbis II Scalp Cooler, always push it from the rear • Always disconnect the power cable, before moving the Orbis II Scalp Cooler • During operation, ensure the Orbis II Scalp Cooler gives easy access to the power lead or mains plug • Exercise care when moving the Orbis II Scalp Cooler over uneven floors or surfaces with obstructions, undulations, ramps or slopes. A slow manoeuvre is recommended • Do not move the Orbis II Scalp Cooler using the support arm • Ensure Orbis II Scalp Cooler is always kept upright

Device safety standards • The Orbis II Scalp Cooler has been tested and complies with British Standard EN60601-1-2006 general requirements for safety for Medical Electrical Equipment. • The Orbis II Scalp Cooler 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 BE SPILLED ON THE TOUCH SCREEN. • 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 nearly impossible for the Orbis II Scalp Cooler to overcool. However, for added safety, the Orbis II Scalp Cooler employs visual warnings to alert the user if the coolant temperature is not within the operating conditions and has an automatic shutdown feature to prevent significantly cold temperatures being reached.

Visual Warnings

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DEVICE HANDLING AND SAFETY

Visual Warnings • The coolant temperature in the Orbis II Scalp Cooler is continuously monitored • If the temperature is observed to be 5°C/41°F above the set point the Status Symbols will be red and the text will read “NOT READY” as shown in fig 1 • The Status Symbol will be green and state “OK” 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 be seen in fig 41.

ORBIS 2

PATIENT 2

Fig 1.

Automatic shutdown feature • The refrigeration unit in the Orbis II Scalp Cooler will automatically cease to operate if the temperature of the coolant inside the coolant tank drops to -15°C/5°F • The touch screen will show the black warning screen displayed in fig 2, the red border will flash to further alert the attention of the user • Touching this warning screen will cause the Orbis II Scalp Cooler to restart; the warning screen will reappear upon restart if the temperature of the coolant temperature is -15°C/5°F or lower

SAFETY SHUTDOWN. TOUCH TO RESTART GURU MEDITATION: #TLOW REASON: Temperature too low

Fig 2.

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DEVICE HANDLING AND SAFETY

Temperature sensor technical error WARNING The visuals on the touch screen display will begin to flash and an audible signal will sound once the Action required box has been on the screen for 10 minutes. Selecting “no” will silence the sound and cause the Action Required Box to disappear.

• In the event of a technical fault with the temperature sensor the black warning screen in fig 3 will appear on the touch screen. The red border will flash to further alert the attention of the user. • Touching the screen will cause the Orbis II Scalp cooler to restart; a message on the start up screen will indicate if the fault still persists. (fig 4) • The operational set up screen shown in fig 5 will automatically appear on the touchscreen display if the technical fault still persists.

SAFETY SHUTDOWN. TOUCH TO RESTART GURU MEDITATION: #TLOW REASON: Sensor Malfunction, safety protection activated.

Fig 3.

Fig 4.

Action Required SYSTEM IN SET UP/DIAGNOSTICS MODE

Please select to continue scalp cooling with patient 1.

1 SYSTEM FAULTS FOUND!

Confirm? YES

Fig 5.

NO

Fig 6.

Insufficient flow warning • The coolant flow rate in the Orbis II Scalp Cooler 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. • The red Action Required box shown in fig 6 will appear on the screen if the flow of the coolant becomes obstructed. • A selection does not need to be made in this instance. The Action Required box will automatically disappear when the flow of the coolant increases to a sufficient rate. • 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 Action Required box has not disappeared check the coolant level by using the sight glass on the back of the unit (section 6, pic 8) as a low coolant level can affect the flow rate. Top up the coolant via the coolant filling port until the coolant is level with the coolant level line. • If the fault persists please contact the service help desk.

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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.

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Fig 7.

• When 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 7. A click will be heard when the couplings are successfully connected.

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Fig 8.

• When disconnecting the couplings, simply hold the couplings in both hands and press the white release button as shown in fig 8. The couplings will spring apart. Continue to pull the couplings apart to complete the disconnect procedure.

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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.

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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 9. 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 color coordinated for size via the Paxman logo as shown in Fig 10.

Fig 9.

Fig 10.

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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

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• 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. • Selection of cap size should always be performed with the cap cover removed as shown in Fig 11.

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 11.

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

INFORMATION The following are indicative of use of an incorrect cap size: 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 11.

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SYSTEM PREPARATION PROCEDURE

The following checks should be performed before switching on the Orbis II Scalp Cooler:

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Check coolant is level with the black line (fig 16). 12). Remove red or black plug. look Lookatatcoolant coolantlevel levelwith withplug plugremoved. removed. If required, add coolant slowly via the coolant filling port to the level of the black line. Check the power cable is firmly inserted into the back of the machine (fig 17) 13) Check the plug is inserted into a wall socket and the socket is SWITCHED ON.

Fig 12.

Fig 13.

Switch on the Power Fig 13. When the status symbol turns green the message start pump is displayed Fig 17. Switch on the Pump Fig 13. The Status symbol will rotate and show ‘OK’ Fig 41.

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SYSTEM PREPARATION PROCEDURE

• Switch on the system by pressing the Power switch located at the rear of the machine the switch will illuminate green. • The touchscreen display will show the start up screen shown in fig 14 whilst the system is initiating. This will take approximately 15 seconds. The Home Screen will then load automatically and the refrigeration system will start. • The Status Symbol on the home screen will be red and the text will read “WAIT” (fig 15) for approximately 15 seconds before changing to read “NOT READY” (fig 16), the symbol will have a diagonal line through the centre to show that the coolant is not flowing. • When system has cooled down to the operating temperature the System Status Symbol will turn green and the text will read “START PUMP” (fig 17).

ORBIS 2

PATIENT 2

Fig 14

Fig 15.

ORBIS 2

ORBIS 2

PATIENT 2

Fig 16.

PATIENT 2

INFORMATION It is not necessary to attach the caps or switch on the pump whilst the system is cooling the coolant to its operating temperature. If the pump is turned on with no cooling caps attached, the Home Screen will display the ‘attach cap’ status symbols when the device has cooled down to the operating temperature. It will take approximately 20 minutes for the Orbis II Scalp Cooler to cool down to the operating temperature with the pump switched off. The user may decide to start the treatment with a warm cap or a pre-cooled cap based upon personal preferences. For more information about the differences between starting with a warm cap or a precooled cap see Section 1.

Fig 17.

Software Version • The touch screen will show the start up screen shown in Fig 14 • Fig 14 shows the software version V1.0.0. • Following this the screen will automatically load and the refrigeration system will start

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PATIENT PREPARATION

• It is recommended to perform any required canulation of patients prior to commencement of scalp cooling, since vasoconstriction caused by scalp cooling can impair venous access.

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• Place a towel around the patient’s shoulders. •  Lightly dampen the patient’s hair using lukewarm water. • Apply a small amount of conditioner to the dampened hair. • Comb the patient’s dampened hair back using a wide tooth comb or fingers so that the patient’s front hair line is visible. This is especially important for patients with a fringe. • If an elasticated headband is 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.

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Fig 18.

Fig 19.

Fig 20.

Fig 21.

CAP FITTING TO THE PATIENT

Option 1: Cap complete with Cap Cover

Cap cover application •  Pinch together the edges of the silicon cap Fig 22. • I nsert the pinched cap inside the cap cover Fig 23. •  Pull the Silicon cap sides outwards to fill the cap cover Fig 24.

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•  Pull the cap cover up over the silicon cap so that the cover fully covers the external surface of the silicone cap Fig 25. •  Ensure that there is a snug fit between the cap cover and the silicone cap. Fig 26-27.

NOTE

Fig 22.

Fig 23.

Fig 24.

Fig 25.

Fig 26.

Fig 27.

Cap fitting to the patient (including 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. •  Lift the front part of the cap cover up so that the silicon cap is visible.

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.

INFORMATION The coolant lines join the cooling cap at the back of the silicone cooling cap. The Paxman logo is in line with the front of the cap cover.

•  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 silicon cap with the hairline and around the ears Fig 28. •  Replace the cap cover rim once you are happy with the cap position Fig 29. •  Fully tighten the chin strap to set the cap in position Fig 30. •  Pull tight on the bungee cord at the back of the cap Fig 31. and lock in place utilizing the bungee cord toggle Fig 32. • Loosen off the chin strap to a more comfortable setting Fig 33. •  Connect the Cap to the Paxman System.

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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 34.

Fig 28.

Fig 29.

Fig 30.

Fig 31.

Fig 32.

Fig 33.

Fig 34.

Fig 35.

Fig 36.

Fig 37.

• Turn the outer cap cover inside out Fig 35. • Place the inside out cap cover on top of the patients head and silicone cap placing your hand on to hold in place Fig 36. • Roll down the cap cover ensuring all the inner silicone cap is totally covered Fig 37 & 29. • Fully tighten the chin strap to set the cap in position Fig 30. • Pull tight on the bungee cord at the back of the cap Fig 31. and lock in place utilizing the bungee cord toggle Fig 32. • Loosen off the chin strap to a more comfortable setting Fig 33. • 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.

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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.

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D.