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Summary of Contents for MacroMedics DSPS
- Page 1 MANUAL 112100 Instructions for use English Instructions DSPS Double Shell Positioning System ® & SSPS Single Shell Positioning System ® DSPS SSPS MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com...
- Page 2 Manual DSPS & SSPS Instructions for use [ This page is intentionally left blank ] 02082021V19IFU112100 MacroMedics ®...
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Page 3: Table Of Contents
Manual DSPS & SSPS Instructions for use Table of Contents 1. Warnings 2. MRI Safety Information 3. Intended Use 4. Positioning Options 5. Cradle Set-Up 6. Mask Set-Up 7. Patient Set-Up 8. Supine Treatment 9. Prone Treatment 10. Using shims 11. -
Page 4: Warnings
• 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 02082021V19IFU112100 MacroMedics ®... -
Page 5: Intended Use
112780 DSPS® Cradle-V H • 112710 DSPS® Cradle-MEXF H • 112790 DSPS® Cradle-QA H • 171210 DSPS® Cradle-MEXF H RE • 112720 DSPS® Cradle-O H 3. Intended Use Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated. 02082021V19IFU112100... -
Page 6: Positioning Options
DSPS & SSPS Instructions for use 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 •... - Page 7 115860M Mask SSPS™-FVRL 115620M Mask SSPS™-FSO 115870M Mask SSPS™-FSVRSL 115670M Mask SSPS™-FSOL 114550M 114530M Mask UMCN Mask DSPS®-OS Note: MacroMedics offers thermoplastic masks with special cut-outs for patients with long hair and for treatments using surface guided radiotherapy systems. 02082021V19IFU112100 MacroMedics ®...
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Page 8: Cradle Set-Up
DSPS & SSPS Instructions for use 5. Cradle Set-Up For optimum set-up stability, MacroMedics recommends using a baseplate which is secured to the couchtop. CRADLES WITH PLUNGERS AND QUICKFASTENERS Ensure that the Plungers or Quickfasteners are in the released position. - Page 9 Manual DSPS & SSPS Instructions for use TYPE - O CRADLES Ensure that the locking knobs are in the released position. 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.
- Page 10 Manual DSPS & SSPS Instructions for use 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.
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Page 11: Mask Set-Up
• Follow your department’s patient positioning protocol for head and neck patients. • For DSPS treatments, there should be approximately 1 finger 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. -
Page 12: Supine Treatment
Lift the patient’s head or ask the patient to sit up. Place the black frame onto the DSPS cradle, with the MacroMedics logo facing upwards. Ensure that all of the frame’s plungers are pushed properly into the holes in the cradle rim. - Page 13 After 5 minutes, the mask should have fully set. MOULDING A SUPINE FACIAL MASK [DSPS AND SSPS] Lay the patient in the supine position with the head resting on the occipital mask for DSPS or supine head support for SSPS.
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Page 14: Prone Treatment
Cure and cool the mask for at least 5 minutes. Release the plungers and remove the mask(s) carefully. Label the mask(s) with the patient’s name/ identifier. 9. Prone Treatment Double Shell Positioning System (DSPS) for prone treatment 02082021V19IFU112100 MacroMedics ®... - Page 15 Take the mask out of the waterbath and dry it between two towels. Check the temperature of the mask material. Position the mask above the patient’s face, with the MacroMedics logo facing downwards. The nose hole should be positioned on the superior tip of the nose first. Stretch the mask down to the Prone Tool rim in a smooth, continuous movement for even stretch of the material.
- Page 16 Place the prone mask, face down on the cradle. MOULDING A PRONE OCCIPITAL MASK [DSPS AND SSPS] Lay the patient in the supine position with the head resting on the occipital mask for DSPS or prone head support for SSPS.
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Page 17: Using Shims
Label the mask(s) with the patient’s name/ identifier. 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. -
Page 18: Cleaning, Storage And Disposal
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. -
Page 19: Glossary Of Symbols
Manual DSPS & SSPS Instructions for use 14. Glossary of Symbols Symbol Symbol Name Description of Symbol EC declaration of conformity by manufacturer. European Conformity Indicates the medical device manufacturer. Manufacturer Indicates the manufacturer’s catalogue number so Catalogue Number that the medical device can be identified. - Page 20 MacroMedics BV Oostbaan 670 2841ML Moordrecht The Netherlands +31(0)182 389 777 info@macromedics.com www.macromedics.com (Visit www.macromedics.com for a digital copy of this manual)
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