MacroMedics DSPS User manual

DSPS ®Double Shell Positioning System
&
SSPS ®Single Shell Positioning System
MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
DSPS
SSPS
MANUAL 112100
Instructions for use
English Instructions

Manual
Instructions for use DSPS & SSPS
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02082021V19IFU112100 MacroMedics ®
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Manual
Instructions for use DSPS & SSPS
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02082021V19IFU112100 MacroMedics ®
Table of Contents
1. Warnings 4
2. MRI Safety Information 4
3. Intended Use 5
4. Positioning Options 6
5. Cradle Set-Up 8
6. Mask Set-Up 11
7. Patient Set-Up 11
8. Supine Treatment 12
9. Prone Treatment 14
10. Using shims 17
11. Cleaning, Storage and Disposal 18
12. Warranty 18
13. Notices 18
14. Glossary of Symbols 19

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1. Warnings
• Inspect the device thoroughly before use. Do not use the device if damaged.
• Check individual components on MR-safety when used together in a patient positioning system.
• Do not use MR unsafe items in an MR environment.
• Do not use the thermoplastic mask after its expiry date.
• The thermoplastic masks are for single patient use.
• Ensure that the mask is not too hot for skin contact before placing it on the patient.
• Do not remove the mask from the patient until the material cools completely. Removing the
thermoplastic mask before it has set may result in the mask’s deformation.
• If using more than one shim, do not exceed a thickness of 1.5 mm.
• In the USA, federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner.
2. MRI Safety Information
2.1 MR SAFE:
The following devices are MR safe:
• 111220 SSPS™ Cradle RE MR
• 111530 SSPS™ Cradle S-Type, MR
• 111610 SSPS™ Cradle Type-O, MR
• 111650 SSPS™ Cradle ExaFix™ MR
• 112910 DSPS® Cradle-MEXF H MR
• 112920 DSPS® Cradle-O H MR
• 112930 DSPS® Cradle-S H MR
• 171250 DSPS® Cradle-M H RE MR
Released
Position
Locked
Position
Incorrect
Position
(locked)

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• 112640 DSPS® Shim set
• 113390 DSPS® GLX Shim Set
• 113490 DSPS® SARY Shim Set
• 114500M Mask SSPS™-FN
• 114530M Mask UMCN
• 114550M MMask DSPS®-OS
• 115620M Mask SSPS™-FSO
• 115670M Mask SSPS™-FSOL
• 115560M Mask SSPS™-FL
2.2 MR UNSAFE:
The following devices are MR unsafe:
• 111110 SSPS Cradle Type ITV
• 111120 SSPS™ Cradle RE
• 111520 SSPS™ Cradle S-Type
• 111600 SSPS™ Cradle Type-O
• 111620 SSPS™ Cradle ExaFix™
• 111630 SSPS™ Cradle U
• 112710 DSPS® Cradle-MEXF H
• 112720 DSPS® Cradle-O H
3. Intended Use
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
• 115510M Mask SSPS™-F
• 115520M Mask SSPS™-FS
• 115570M Mask SSPS™-FSL
• 115720M Mask SSPS™-FSS
• 115770M Mask SSPS™-FSSL
• 115810M Mask SSPS™-FVR
• 115820M Mask SSPS™-FSVRS
• 115860M Mask SSPS™-FVRL
• 115870M Mask SSPS™-FSVRSL
• 112730 DSPS® Cradle-S H
• 112740 DSPS® Cradle-VRT H
• 112750 DSPS® Cradle-B H
• 112760 DSPS® Cradle-I H
• 112770 DSPS® Cradle-U H
• 112780 DSPS® Cradle-V H
• 112790 DSPS® Cradle-QA H
• 171210 DSPS® Cradle-MEXF H RE

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4. Positioning Options
• Double Shell Positioning System (DSPS) uses two thermoplastic masks and a cradle to support the
patient’s head.
• Single Shell Positioning System (SSPS) uses a head support, a cradle, and one thermoplastic
mask to support the patient’s head.
The following tables provide details on the treatment positioning options possible with each mask and
cradle type.
Cradle Positioning Options
DSPS Cradle
111110 SSPS Cradle Type ITV
112710 DSPS® Cradle-MEXF H
112720 DSPS® Cradle-O H
112730 DSPS® Cradle-S H
112740 DSPS® Cradle-VRT H
112750 DSPS® Cradle-B H
112760 DSPS® Cradle-I H
112770 DSPS® Cradle-U H
Supine and Prone DSPS
Cradle Positioning Options
SSPS Cradle
111120 SSPS™ Cradle RE
111220 SSPS™ Cradle RE MR
111520 SSPS™ Cradle S-Type
111530 SSPS™ Cradle S-Type, MR
111600 SSPS™ Cradle Type-O
Supine and Prone DSPS and SSPS
112780 DSPS® Cradle-V H
112790 DSPS® Cradle-QA H
112910 DSPS® Cradle-MEXF H MR
112920 DSPS® Cradle-O H MR
112930 DSPS® Cradle-S H MR
171210 DSPS® Cradle-MEXF H RE
171250 DSPS® Cradle-M H RE MR
111610 SSPS™ Cradle Type-O, MR
111620 SSPS™ Cradle ExaFix™
111650 SSPS™ Cradle ExaFix™ MR
111630 SSPS™ Cradle U

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Mask Options for Supine
Treatment
Mask options for Prone
treatment
114550M Mask DSPS®-OS
115510M Mask SSPS™-F
115520M Mask SSPS™-FS
115560M Mask SSPS™-FL
115570M Mask SSPS™-FSL
115620M Mask SSPS™-FSO
115670M Mask SSPS™-FSOL
114500M Mask SSPS™-FN
114550M Mask DSPS®-OS 114530M Mask UMCN
Note: MacroMedics offers thermoplastic masks with special cut-outs for patients with long hair and for
treatments using surface guided radiotherapy systems.
DSPS ONLY DSPS and SSPS
115720M Mask SSPS™-FSS
115770M Mask SSPS™-FSSL
115810M Mask SSPS™-FVR
115820M Mask SSPS™-FSVRS
115860M Mask SSPS™-FVRL
115870M Mask SSPS™-FSVRSL

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5. Cradle Set-Up
For optimum set-up stability, MacroMedics recommends using a baseplate which is secured to the
couchtop.
5.1 CRADLES WITH PLUNGERS AND QUICKFASTENERS
I. Ensure that the Plungers or Quickfasteners are in the released position.
II. Align and slot the cradle onto the baseplate.
III. Lock the cradle in place by pressing down on the plungers or quickfasteners.
IV. After use, the cradle can be detached by pulling on the plungers or quickfasteners and
returning them to the released position.
Cradle Plunger Cradle Quickfastener
in Released Position in Released Position

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5.2 TYPE - O CRADLES
I. Ensure that the locking knobs are in the released position.
II. Align and slot the cradle onto the baseplate.
III. Lock the cradle in place by rotating the locking knobs 90 degrees so the knobs are pointing outwards.
IV. After use, the cradle can be detached by returning the locking knobs to the released position.
5.3 TYPE - B CRADLES
I. Attach the two pivots to the baseplate by screwing them into place. Align and slot the cradle
onto the baseplate.

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II. Secure the cradle in place by tightening the white knobs at both side of the cradle.
Ensure that the locking knobs (circled) are in the released position to be able to place the
reference box over the cradle.
Reference Box
III. When using the reference cradle, place the reference box over the cradle, as shown below.
Secure it in place by rotating the locking knobs 90 degrees so the knob is pointing towards
the cranial end of the board.
IV. After use, the cradle and reference box can be detached by returning the locking knob to
the released position and loosening the white knobs.

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5.4 OTHER CRADLES
Other cradles are aligned and slotted into the baseplate and are subsequently xed in place
using the third-party baseplate’s clamping mechanisms or locks. Refer to the corresponding
Instructions for Use for further details.
6. Mask Set-Up
The masks are packaged without the plungers inserted. Prior to mask usage, insert the supplied
Plungers into the Plunger holders (holes) in the white frame of the mask. Gently push them
through until they are in released position.
7. Patient Set-Up
• Follow your department’s patient positioning protocol for head and neck patients.
• For DSPS treatments, there should be approximately 1 nger width in between the cradle rim
and the top on the patient’s head.
• For SSPS treatments, position the patient by letting them lay down with the head on the head
support.
• When using a mask on a patient with long hair, place the hair in ponytail on the top left side of
the patient’s head.
Released
Position Locked
Position
Incorrect
Position (locked)

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8. Supine Treatment
Double Shell Positioning System (DSPS) Single Shell Positioning System (SSPS)
for supine treatment for supine treatment
8.1 MOULDING A SUPINE OCCIPITAL MASK [DSPS ONLY]
1. Take a new supine occipital mask (dark blue RayOC thermoplastic mask with the black frame).
2. Heat the mask in a waterbath with a temperature between 68°C and 70°C (154.4°F and 158°F)
for 15 to 20 seconds until it becomes sufciently pliable.
3. Take the mask out of the waterbath and dry it between two towels.
4. Check the temperature of the mask material.
5. Lift the patient’s head or ask the patient to sit up.
6. Place the black frame onto the DSPS cradle, with the MacroMedics logo facing upwards.
7. Ensure that all of the frame’s plungers are pushed properly into the holes in the cradle rim.
8. Place the patient’s head on the occipital mask and gently position the patient’s head on
top of the mask in the desired position for treatment.
9. The mask will sink in due to the weight of the head. If the depth of the impression is not deep
enough, gently apply pressure with the palm of your hands on the patient’s forehead
to achieve the prescribed position and depth for the mask. We recommend an impression depth
of approximately 1 cm above the cradle’s base. Different positions may be preferred depending
on the target area.

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10. Use your hands to mould the mask to the side of the neck and the cranial area, including
occipital bones. The ventral inferior line of the base of skull is an optimal landmark to
mould. Hold the mask in position for 10-20 seconds to ensure an impression is formed.
11. When the mask material starts to harden, you can use cold packs or cold wet towels to cool the
mask and speed up the setting process.
12. Keeping the patient in the same position, let the mask cool
and set for at least 5 minutes.
13. After 5 minutes, the mask should have fully set.
8.2 MOULDING A SUPINE FACIAL MASK [DSPS AND SSPS]
1. Lay the patient in the supine position with the head resting on the occipital mask for DSPS or
supine head support for SSPS.
2. Take a new supine facial mask (Perforated RayPRO thermoplastic mask with the white frame).
3. Make sure that all 5 black plungers are in the released position.
4. Heat the mask in a waterbath with a temperature between 68°C and 70°C (154.4°F and 158°F)
for 1 to 2 minutes until it becomes sufciently pliable.
5. Take the mask out of the waterbath and dry it between two towels.
6. Check the temperature of the mask material.
7. Position the mask above the patient’s face, with MacroMedics’ logo facing upwards.
8. The nose hole should be positioned on the superior tip of the nose rst. Stretch the mask down to
the cradle rim in a smooth, continuous movement for even stretch of the material.
Nose hole rst

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9. When using a mask on a pateint with long hair, place the opening in the frame around the
ponytail.
10. Place the white frame slowly onto the black frame.
11. Secure the mask in place by pressing down the plungers. Be careful not to pinch the patient’s
ears or skin around the neck.
12. Use both hands to mould the structures of the face like the nose bone, orbitae, chin, and
forehead.
13. If applicable, after moulding the facial region of the mask, proceed with moulding the mask
around the neck and shoulders.
14. To speed up the setting process, you can use cold packs or cold, wet towels to cool the mask.
15. Cure and cool the mask for at least 5 minutes.
16. Release the plungers and remove the mask(s) carefully.
17. Label the mask(s) with the patient’s name/ identier.
9. Prone Treatment
Double Shell Positioning System (DSPS) for prone treatment

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9.1 MOULDING A PRONE FACIAL MASK [DSPS ONLY; REQUIRES PRONE TOOL SET]
1. Secure the Prone Tool to the couch top or treatment board using a CouchStrip or similar.
Prone Tool Set
2. Lay the patient in the supine position with the head resting on the Support Cushions.
3. Place the Reference Bridge on the Prone Tool to determine if the position of the patient’s
head is at the correct height. The tip of the nose should touch the reference tool to ensure
that there will be enough distance between the bottom of the cradle and the patient’s
head when the facial prone mask is placed on the cradle. Add or remove Support Cushions
to achieve the desired height.
4. Once the patient’s head is at the correct height, remove the Reference Bridge.
5. Take a new prone facial mask (Non-perforated MacroCast thermoplastic mask with the
black frame).
6. Heat the mask in a waterbath with a temperature between 68°C and 70°C (154.4°F and 158°F)
for 2 to 4 minutes until it becomes sufciently pliable.
7. Take the mask out of the waterbath and dry it between two towels.
8. Check the temperature of the mask material.
9. Position the mask above the patient’s face, with the MacroMedics logo facing downwards.
10. The nose hole should be positioned on the superior tip of the nose rst. Stretch the mask
down to the Prone Tool rim in a smooth, continuous movement for even stretch of the
material.
11. Lock the mask in place using the swivel clamps on the prone tool.
12. Use both hands to mould the structures of the face like nose bone, orbitae, chin, and forehead.

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For male patient’s, it is highly recommended to fold up the mask
material in the neck section to avoid pressure in the region when
the patient is lying in the prone position.
13. To speed up the setting process, you can use cold packs or
cold, wet towels to cool the mask.
14. Cure and cool the mask for at least 5 minutes. Ensure that this
mask has fully set prior to moulding the occipital mask as the
weight of the patient could otherwise cause it to stretch.
15. Release the plungers and remove the mask carefully.
16. Replace the Prone Tool with an appropriate cradle.
17. Place the prone mask, face down on the cradle.
9.2 MOULDING A PRONE OCCIPITAL MASK [DSPS AND SSPS]
1. Lay the patient in the supine position with the head resting on the occipital mask for DSPS or
prone head support for SSPS.
2. Take a new prone occipital mask (Perforated RayPRO thermoplastic mask with the white
frame).
3. Make sure that all 5 black plungers are in the released position.
4. Heat the mask in a waterbath with a temperature between 68°C and 70°C (154.4°F and 158°F)
for 1 to 2 minutes until it becomes sufciently pliable.
5. Take the mask out of the waterbath and dry it between two towels.
6. Check the temperature of the mask material.
7. Position the mask above the patient’s head with MacroMedics’ logo facing upwards.
8. Stretch the mask down to the cradle rim in a smooth, continuous movement for even stretch
of the material.
9. Secure the mask in place by pressing down the plungers. Be careful not to pinch the patient’s
ears or skin around the neck.

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10. Use your hands to mould the mask to the side of the neck and the cranial area, including
occipital bones. The ventral inferior line of the base of skull is a particularly optimal landmark to
mould.
11. To speed up the setting process, you can use cold packs or cold, wet towels to cool the mask.
12. Cure and cool the mask for at least 5 minutes.
13. Release the plungers and remove the masks carefully.
14. Label the mask(s) with the patient’s name/ identier.
10. Using shims
For DSPS treatments, to maintain patient comfort in the case of facial swelling, the separation between
the lower and upper masks may be increased by placing one or two shims between the masks. Shims are
available in 1.0 mm and 0.5 mm thickness. The shims can be used for both supine and prone position. An
example of a shim used as part of the DSPS supine set-up can be seen below.
Check the tab of the shim (the tab is circled in blue below) to identify whether it is a 1.0 mm Shim or a
0.5 mm Shim.
Shims can be used in the following combinations:
• One 0.5 mm Shim only
• One 1.0 mm Shim only
• One 0.5 mm Shim and one 1.0 mm Shim only
Shim with the tab highlighted.
A label on the tab will identify whether
it is a 1.0 mm Shim or a 0.5 mm Shim
Upper Frame
Shim
Lower Frame
Cradle
Example of a Shim being used as part of a
DSPS supine set-up

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11. Cleaning, Storage and Disposal
• Clean the device before and after every use with 70% Isopropanol or soapy water, applied with a soft
cloth. Rinse with water and dry properly. Follow the cleaning precautions provided by the
manufacturer of the cleaning agent.
• Store the thermoplastic Masks in a dry place away from direct sunlight.
• Store the products with the Quickfasteners in the released position to prevent grommet
deformation. See the image below.
• Dispose of the device in accordance with the local laws and regulations applicable to your
country.
12. Warranty
The MacroMedics products are warranted to be free from defects in manufacturing, material and
construction. The warranty is for 1 year starting from the date of delivery.
Product warranties remain valid provided the product was installed and/or used according to the
instructions. Defects, malfunctions or failures caused by nature, misuse, abuse and unauthorised
alteration or repair are not warranted.
This warranty is limited to the repair and/or replacement at the sole discretion of MacroMedics.
13. Notices
Any serious incident that has occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user or patient is established.
Released
Position Locked
Position
Incorrect
Position (locked)

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14. Glossary of Symbols
Symbol Symbol Name Description of Symbol
European Conformity
EC declaration of conformity by manufacturer.
Manufacturer
Indicates the medical device manufacturer.
Catalogue Number
Indicates the manufacturer’s catalogue number so
that the medical device can be identied.
GS1 Code: (10)
Batch Code
Indicates the manufacturer’s batch code so that the
batch or lot can be identied.
GS1 Code: (21)
Serial Number
Indicates the manufacturer’s serial number so that a
specic medical device can be identied.
Consult Instruction for Use
Indicates the need for the user to consult the
instructions for use.
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be presented
on the medical device itself.
Prescription Only
Devices for sale to physicians or trained healthcare
providers only.
Keep Dry
Indicates a medical device that needs to be
protected from moisture.
Keep Away from Sunlight
Indicates a medical device that needs protection
from light sources.
GS1 Code: (17)
Use-by Date
Indicates the date after which the medical device is
not to be used. When the graphical symbol is used,
the date is expressed in the format: YYYY-MM-DD.
On the other hand, when expressed next to the GS1
Code (17), the date is in the format: YYMMDD.
MR Safe
An item that poses no known hazards resulting from
exposure to any MR environment. MR Safe items are
composed of materials that are electrically
nonconductive, nonmetallic, and nonmagnetic.
MR Unsafe
An item which poses unacceptable risks to the
patient, medical staff or other persons within the MR
environment.
Single patient multiple use
To indicate that the medical device may be used
multiple times (multiple procedures) on a single
patient.

MacroMedics BV
Oostbaan 670
2841ML Moordrecht
The Netherlands
[phone]
[email protected]
www.macromedics.com
(Visit www.macromedics.com for a digital copy of this manual)