ORBIS I Instruction for Use Issue 4 Jan 2014

Index SECTION NO.

PAGE NO.

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INTRODUCTION TO SCALP COOLING DEVICE DESCRIPTION INTENDED USE/INDICATIONS FOR USE CONTRAINDICATIONS WARNINGS AND PRECAUTIONS SIDE EFFECTS EQUIPMENT SUPPLIED GUIDE TO THE SYSTEM AND PARTS DEVICE HANDLING AND SAFETY QUICK RELEASE COUPLINGS COOLING CAPS INFORMATION PATIENT CAP SIZE SELECTION SYSTEM PREPARATION PROCEDURE CAP PRE-COOLING PATIENT PREPARATION CAP FITTING TO THE PATIENT PRE-INFUSION SCALP COOLING POST INFUSION COOLING TEMPORARY DISCONNECTION DURING COOLING: BATHROOM VISITS COMPLETION OF POST INFUSION SCALP COOLING CAP REMOVAL CAP AND COVER CLEANING CAP STORAGE DISPOSAL OF DAMAGED OR CONTAMINATED COMPONENTS PERIODIC MAINTENANCE THE INBUILT HELP FUNCTION MATERIAL SAFETY AND DATA MANUFACTURER CONTACT DETAILS

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SCALP COOLING Introduction to scalp cooling SECTION 1

Hair loss (alopecia) is recognised as one of the most common and distressing side-effects of chemotherapy. Chemotherapy drugs rely for their effectiveness in treating cancer 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, which 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 preinfusion 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 precooled 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 be 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 SECTION 2 The Orbis I Scalp Cooler is a compact, mobile refrigeration unit, which 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 SECTION 3

The Orbis I Scalp Cooler is indicated for use to reduce chemotherapy-induced hair loss in cancer patients receiving systemic chemotherapy with alopecia causing chemotherapy agents. The Orbis I 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 Coolers. 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 SECTION 4 • Haematological malignancies (leukaemia, non Hodgkins and other generalised lymphomas) • Cold allergy • Cold agglutinins • Manifest scalp metastases • Imminent bone marrow ablation chemotherapy • Imminent skull irradiation

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Warnings and Precautions SECTION 5

• 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 chemotherapyinduced hair loss varies from patient to patient and according to the chemotherapy regime administered. • The Orbis I Scalp Cooler should only be used by appropriately qualified healthcare professionals who have been trained in operation of the device. • 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

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

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Side Effects SECTION 6 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 SECTION 7

Equipment consists of: 1.

Electronically operated refrigeration unit complete with power cable.

2.

1 set of coolant lines with quick release couplings, covered with insulation and neoprene shroud.

3.

Three standard cooling caps. 1 x small, 1 x medium and 1 x large* complete with insulation covers and quick release couplings.

4.

Single adjustable coolant line support arm complete with cap support.

5.

1 litre of coolant (top up).

6.

Plastic storage bin (UK only).

7.

Instructions for use.

8.

Quick guidance for use notes.

9.

Recommended cooling times information sheets.

10. Patient information leaflets. * It is optional to have any combination of caps

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Guide to the System and Parts SECTION 8 1.

Coolant line inlet and outlet connections

2.

Power Switch (illuminates green)

3.

Pump Switch (illuminates green)

4.

Mains Power Connection

5.

Coolant line support arm – height adjustment

6.

Coolant Sight Glass

7.

Coolant Level Line

8.

Coolant Filling Point

9.

System Touch Screen Controller – Home Screen

5

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8

3

7

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Device Handling and Safety SECTION 9-1 MOVING THE DEVICE The Orbis I Scalp Cooler is provided with 4 swivel castors on the base of the refrigeration unit to enable mobility between uses. The two sets of castors at the front of the device both 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.

WARNINGS AND PRECAUTIONS • If the Orbis I 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 I Scalp Cooler. • When moving the Orbis I Scalp Cooler, always push it from the rear. • Always disconnect the power cable, before moving the Orbis I Scalp Cooler. • During operation, ensure the power lead is easily accessible. • Exercise care when moving the Orbis I Scalp Cooler over uneven floors or surfaces with obstructions, undulations, ramps or slopes. A slow manoeuvre is recommended. • Do not move the Orbis I Scalp Cooler using the support arm. • Ensure Orbis II Scalp Cooler is always kept upright. DEVICE SAFETY STANDARDS • The Orbis I Scalp Cooler has been tested and complies with British Standard EN60601-1-2006 general requirements for safety for Medical Electrical Equipment. • The Orbis I 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. TOUCHSCREEN CONTROLLER CARE • DO NOT ALLOW LIQUIDS TO BE SPILLED ON 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 nearly impossible for the Orbis I Scalp Cooler to overcool. However, for added safety, the Orbis I 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.

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 5oC above the set point during this initial cooling down process. IFU Orbis I

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Device Handling and Safety SECTION 9-2 VISUAL WARNINGS •

The coolant temperature in the Orbis I Scalp Cooler is continuously monitored.

•

If the temperature is observed to be 5°C above the set point the Status Symbols will be red and the text will read “NOT READY” as shown in figure 3.

•

The Status Symbol will be green and state “OK” if the coolant temperature is below the temperature which is 5°C above the set point and sufficient flow is detected. This status symbol can be seen in figure 24. Figure 3

Automatic Shutdown Feature • The refrigeration unit in the Orbis I Scalp Cooler will automatically cease to operate if the temperature of the coolant inside the coolant tank drops to -15°C. • The touch screen will show the black warning screen displayed in figure 4, the red border will flash to further alert the attention of the user. • Touching this warning screen will cause the Orbis I Scalp Cooler to restart; the warning screen will reappear upon restart if the temperature of the coolant temperature is -15°C or lower. Figure 4

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Device Handling and Safety SECTION 9-3 TEMPERATURE SENSOR TECHNICAL ERROR

• In the event of a technical fault with the temperature sensor the black warning screen in figure 5 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 I Scalp cooler to restart; a message on the start up screen will indicate if the fault still persists (figure 6). The operational set up screen shown in figure 7 will automatically appear on the touchscreen display if the technical fault still persists.

Figure 6

Figure 5

Figure 7

INSUFFICIENT FLOW WARNING • The coolant flow rate in the Orbis I 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 figure 8 will appear on the screen if the flow of the coolant becomes obstructed. Figure 8 • 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 (figure 1) 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.

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.

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Quick Release Couplings SECTION 10

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.

• 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 figure 9. A click will be heard when the couplings are successfully connected.

Figure 9 • When disconnecting the couplings, simply hold the couplings in both hands and press the white release button as shown in figure 10. The couplings will spring apart. Continue to pull the couplings apart to complete the disconnect procedure.

Figure 10

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Cooling Cap Information SECTION 11

Patients’ heads vary enormously in shape and size. We have developed a number of different sized caps to accommodate these varying sizes. For ease of identification the silicone caps have been colour coded with a coloured crown as shown in figure 11. • • • • •

extra small, XS, yellow small, S, red medium, M, purple large, L, blue extra large, XL, green

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 XS, S, M, L or XL depending upon the size of the cap. The caps are made from medical grade soft silicone tubing. They are light in weight but flexible and strong to withstand multiple use. The silicone caps are supplied with a neoprene cover. The purpose of this cover is to absorb condensation from 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 Velcro strap and chin strap also ensure a snug, tight fit of the cooling cap. The cap covers are also colour co-ordinated for size via the Paxman logo to match the caps in their corresponding colours as shown in figure 12.

Figure 11

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Patient Cap Size Selection SECTION 12-1 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. PRECAUTION Good all-over contact of the cap with the scalp is essential for a successful outcome. CAP MEASURING AND FITTING • It is recommended to allow time in the pre consultation appointment prior to the commencement of chemotherapy treatment for fitting of the correct cap size. • Selection of cap size should always be performed with the cap cover removed as shown in figure 13 and 14. It is important that the top of the cap is touching the crown of the patient’s head.

Figure 14

Figure 13 WARNING 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. Hair loss around hairline – INSUFFICIENT HAIR COVERAGE: USE A LARGER CAP WITH A SMALLER COVER.

• Position the front of the cap approximately 2mm below the hair line on the patient’s forehead. The cap needs to fit around the entire hairline at the back and needs to be tight; otherwise the patient would suffer hair loss at the back and/or sides. • If the cap is too large you will be able to put your hand up the back of the cap. • If the patient is in between sizes, for example a small cap is too small and a medium cap is too big, then we recommend that the medium cap is used with a small cap cover to achieve a tighter fit. This method can be used with all cap sizes. • Likewise if a cap does not reach the whole hairline – use the larger cap with a smaller cap cover to again ensure full coverage!

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Patient Cap Size Selection SECTION 12-2 CAP COVER APPLICATION 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.

• Place the silicone cap over your knee so that the front of the cap is facing directly towards you and line up the front of the cap cover with the front of the silicone cooling cap. (figure 15) • Pull the cap cover down over the silicone cooling cap so that the cover fully covers the external surface of the silicone cooling cap (figure 16). • Ensure that there is a snug fit between the cap cover and silicone cooling cap. (fig 17)

WARNING Never use the cap without the appropriate size cap cover

Figure 15

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Figure 17

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System Preparation Procedure SECTION 13-1 • The following checks should be performed before switching on the Orbis I Scalp Cooler: Check coolant level is with the black line (figure 18). Remove red or black plug. look at coolant level with plug 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 (figure 19) Check the plug is inserted into a wall socket and the socket is SWITCHED ON.

Figure 18

Figure 19

• 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 figure 20 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 Symbols on the home screen will be red and the text will read “WAIT” (figure 21) for approximately 15 seconds before changing to read “NOT READY” (figure 22), 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 Symbols will turn green and the text will read “START PUMP” (figure 23).

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Figure 21

Figure 22

Figure 23

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System Preparation Procedure SECTION 13-2

• If the user is starting the scalp cooling treatment by wearing a warm cap it is appropriate to skip the next section (section 14) and prepare for the treatment by following the instructions in section 15. • If the user is starting the scalp cooling treatment with a pre-cooled cap it is appropriate to continue to follow the instructions in section 14. IMPORTANT NOTES 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 I 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 pre-cooled cap see Section 1.

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Cap Pre-Cooling SECTION 14 PATIENT USE • When the system has cooled the coolant to its operating temperature, the system status symbol on the Home Screen will be green with a cross through it and the Home Screen will display ‘Start Pump’ (figure 23). • Attach the cooling cap to the coolant line by following the procedure described in section 10 and cover the connectors with the coolant line Velcro sleeve. • Place the connected cooling cap on the cap stand with a towel inside the cap; the towel is used to prevent condensation and frost from building up inside the cap. • Switch on the pump using the pump ON/OFF switch on the back of the Orbis I Scalp Cooler (figure 2). • The unit will register that it has a cap attached. • The cap must now be left connected to the system for a minimum of 5 minutes to pre-cool. • Once cap pre-cooling is complete and the cap is ready for use, the Home Screen will display the System Status Symbol in green and the message “OK” as shown in figure 24.

Figure 24 PRECAUTION •

Please ensure the System Status Symbols turn green before you commence pre-cooling.

•

DO NOT PLACE CAPS ON TOP OF ORBIS SYSTEM - USE CAP STANDS.

INFORMATION When you attach a warm cap to the system, the System Status Symbol for that cap may temporarily turn red and state NOT READY. The ATTACH CAP Status Symbol will turn red and an audible signal will sound until the operating temperature is reached. The Status Symbols should not turn red for more than 10 minutes.

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