TALARMADE HeadUp Collar Operating and maintenance manual

HeadUp Collar
Instructional Manual
HCPCS Code LO170
FDA Device No D339081

2HeadUp Collar Instruction Manual

Consult instructions for use
Caution
Manufacturer
CE Logo
FDA Logo
Wear protective gloves
European Authorized
Representative
3HeadUp Collar Instruction Manual
Symbols Glossary
The HeadUp Collar is designed to provide supplementary head and neck
Support for people with head control issues or cervical muscular weakness.
Intended Use
The HeadUp Collar is recommended for use by
individuals experiencing any of the following conditions:
• Head Drop
• Neuromuscular Torticollis
• Neck extensor muscular weakness
• Conditions requiring neck Support and improved alignment/control
Indications for Use
The HeadUp Collar must not be used:
IRUWUHDWPHQWRILQGLYLGXDOVZLWKVHYHUH¿[HGGHIRUPLW\
• over open wounds that may come in to contact with the HeadUp Collar
• unstable cervical fractures
Contraindications

The Instructions for use must be read and
understood before attempting to use the device.
Every component of the HeadUp is
designed to be customised to the patients’
needs and should not be used direct from
WKHER[ZLWKRXWPRGL¿FDWLRQ
,W LV UHFRPPHQGHG WKDW WKH LQLWLDO ¿WWLQJ RI
the HeadUp Collar and Support Struts must
EH FDUULHG RXW E\ D TXDOL¿HG KHDOWKFDUH
professional.
Putting on and taking off the HeadUp Collar will be
easier with a relative/carer assisting.
$OOSHUVRQVLQYROYHGLQWKH¿WWLQJDQGPDLQWHQDQFH
of this device must read and understand the
Instructions for Use prior to applying the HeadUp
Collar and Support Struts.
Care should be taken to instruct the user and carer
RQ WKH FRUUHFW ¿WWLQJ SURFHGXUH DV VKRZQ XQGHU
“Fitting Instructions”.
'XULQJWKHLQLWLDO¿WWLQJWKHLQGLYLGXDODSSO\LQJWKH
HeadUp Collar should ensure that the HeadUp
&ROODULV¿WWHGVHFXUHO\HQRXJKWRSURYLGHSRVWXUDO
head Support, but not lead to discomfort or
unexpected issues such as light-headedness.
If any pressure points can be felt from the location
of the HeadUp Support Struts, adjust/reposition
them slightly to alleviate the load on tissues.
The HeadUp Collar should never dig in or
cause pain. Consult your medical team if
this occurs.
In the case of an emergency the
HeadUp Collar should be removed
prior to performing CPR.
For removal it is not required to detach the HeadUp
6XSSRUW 6WUXWV ¿UVW 9LVXDOO\ FKHFN WKH +HDG8S
Collar before each use.
'R QRW XVH LI WKHUH LV VLJQL¿FDQW GDPDJH
deterioration of the HeadUp Support Struts
or HeadUp Snood. The amount of Support
provided by the HeadUp Support Struts will
reduce over time. When the Support Struts
no longer provide the required amount
of Support, they must be replaced with
QHZ 6XSSRUW 6WUXWV IROORZLQJ WKH ¿WWLQJ
instructions.
If in doubt, please refer to your medical
team treating you for advice before using or
modifying the HeadUp Collar.
If users have sensitive skin, a small
proportion may experience minor irritation
from the HeadUp Collar material. Prior
WR ¿WWLQJ WKH +HDG8S 6XSSRUW 6WUXWV WKH
+HDG8S&ROODUVKRXOGEH¿WWHGWRWKHXVHU
IRUDVKRUWSHULRG¿UVWWKHQUHPRYHGDQGD
visual inspection of the area made to ensure
no skin reaction has taken place.
In the unlikely event that if while wearing
the HeadUp Collar, that any of the following
issues are experienced: Discomfort / skin
irritation / light-headedness – the HeadUp
Collar must be removed. If symptoms do
not resolve swiftly after its removal, contact
your medical team treating you for advice.
If any continued symptoms are experienced
following use of the HeadUp Collar, please
contact your medical team treating you.
The HeadUp Collar and its Support Struts
must not be brought into close proximity or
GLUHFWFRQWDFWZLWKDQ\IRUPRIQDNHGÀDPH
or electrical heating element.
The HeadUp Collar is not recommended for
use whilst smoking
General Instructions
4HeadUp Collar Instruction Manual

5HeadUp Collar Instruction Manual
HeadUp Kit available sizes
Contents in the box
Product Code Description Device
,GHQWL¿HU
HUC/S HeadUp Collar - Small 5055204340587
HUC/M HeadUp Collar - Medium 5055204324938
HUC/L HeadUp Collar - Large 5055204340594
Item No. Item Description Quantity
Fig.1 HeadUp Snood 1
Fig.2 A-Frame – Support Strut, Medium (2mm thick) 1
Fig.3 A-Frame – Support Strut, Firm (3mm thick) 1
Fig.4 Z – Support Strut, Left Side, Medium (2mm thick) 1
Fig.5 Z – Support Strut, Right Side, Medium (2mm thick) 1
Fig.6 Z – Support Strut, Left Side, Firm (3mm thick) 1
Fig.7 Z – Support Strut, Right Side, Firm (3mm thick) 1
Fig.8 Standard 8mm – Support Strut, Medium (2mm thick) 2
Fig.9 Standard 8mm – Support Strut, Firm (3mm thick) 2
Fig.10 Wide 16mm – Support Strut, Medium (2mm thick) 2
Fig.11 Wide 16mm – Support Strut, Firm (3mm thick) 2
Fig.12 HeadUp Component Pouch 1

6HeadUp Collar Instruction Manual
Fig. 1
Fig. 2, 3
Fig. 4, 6
Fig. 5, 7
Fig. 12
Fig. 10, 11
Fig. 8, 9
Contents in the box

7HeadUp Collar Instruction Manual
Putting on and taking off the HeadUp Collar will be easier with an assistant; please ask them
WRUHDGWKHLQVWUXFWLRQVIRUXVHLQIXOO¿UVW
7KH+HDG8S&ROODUPXVWEH¿WWHGE\DQDSSURSULDWHO\WUDLQHGPHGLFDOSURIHVVLRQDO
Each component of the HeadUp Collar must be customised or moulded to conform to the
patient’s body shape whilst delivering the required amount of Support/correction.
Applying the HeadUp Collar
Step 1 – Select the appropriate size HeadUp Collar from the measurement chart in the size guide.
Step 2 – Heat the HeadUp Snood gently using a heat gun on a low setting (or a hair dryer on
medium/high) until the fabric HeadUp Snood is warm to touch.
Do not overheat.
Step 3 – Apply the HeadUp Snood whilst it is warm aligning the
chin of the patient with the Chin section of the HeadUp Snood
Step 4 – Mould the HeadUp Snood to the patient’s body shape with
the head alignment corrected by drawing the two edges of the HeadUp
Snood posteriorly to wrap around the back of the patients’ head/neck
Step 5 – Secure the HeadUp Snood at the back of the neck/head
securely by overlapping the Micro Grip fastening onto the outside of the
HeadUp Snood
Step 6±7KH+HDG8S6QRRGFDQEHWULPPHGZLWKVFLVVRUVWRFXVWRPLVHLWV¿W$SHUWXUHVFDQEHFXW
into the collar for tracheotomies or for a carotid cannula
Step 7±7KH+HDG8S6QRRGPD\UHTXLUHDGMXVWPHQWVPRGL¿FDWLRQVDQGUHSHWLWLRQRIWKHVH
SURFHVVHVWRHQVXUHDQDFFXUDWHDQGFRPIRUWDEOH¿W
Do not leave the wearer of the HeadUp Collar after application without ensuring correct
¿WPHQWDQGXVHUFRPIRUW
If while wearing the HeadUp Collar any of the following issues are experienced: Discomfort /
skin irritation / light-headedness – the HeadUp Collar must be removed and adjusted.
Fitting Instructions

Applying the HeadUp Support Struts
• The HeadUp Collar comes with 4 different shape Support Struts in 2 different thicknesses
(Medium Support 2mm, Firm Support 3mm).
• Each Support Struts are directly attached to the HeadUp Snood using the Micro Grip fastening
adhered to the struts
• The HeadUp Support Struts should be applied to provide the appropriate level of Support or
correction needed for the activity being undertaken.
• The HeadUp Support Struts can be readjusted with heat to meet the changing needs of the
patient.
• The HeadUp Support Struts should be heated and moulded into shape as they are applied
(Using a heat gun on a low setting or a hairdryer on medium/high). Protective gloves should be
worn whilst heating and moulding the HeadUp support struts
• Heat should be applied to the smooth side of the Support Struts not the Micro Grip surface
• The HeadUp Support Struts should be moulded with gradual rather than acute curves.
•
'RQRWVKDSHWKHVWUXWVZLWKRXWKHDWLQJWKHP¿UVW
•
Do not heat the HeadUp Support Struts whilst attached to the HeadUp Collar.
• The HeadUp Support Struts can be added/removed to provide different levels of Support/
SURWHFWLRQDVUHTXLUHGE\HDFKSDWLHQW'LIIHUHQWVWUXWFRQ¿JXUDWLRQVPD\EHUHTXLUHGIRU
different patient activities (eating, drinking, driving).
•
The applied HeadUp Support Struts should never dig in or cause pain/discomfort.
(If this occurs reposition the Support Struts or heat Support Struts to shape of patient).
8HeadUp Collar Instruction Manual
examples of a gradual curves applied to the Support Struts

9HeadUp Collar Instruction Manual
• 7KH6XSSRUW6WUXWVFDQEHXVHGLQPXOWLSOHFRQ¿JXUDWLRQVEDVHGXSRQWKHSDWLHQWV¶QHHGV
comfort (Guidance can be found in “HeadUp Support Strut Position Options” and “Commonly
8VHG6XSSRUW6WUXW&RQ¿JXUDWLRQV´
•
The HeadUp Collar or its Support Struts must not be allowed close to or be brought into
FRQWDFWZLWKDQ\IRUPRIQDNHGÀDPHRUHOHFWULFDOKHDWLQJHOHPHQW
•
Do not overheat the HeadUp Support Struts. Overheating may weaken the Support
Strut and cause the Micro Grip to delaminate from the Support Strut.
• A-Frame Support Strut Placement:
ÀH[WKHKHDWHG6XSSRUW6WUXWDIWHUZKLOVW¿WWLQJLWDWWDFKLQJ
under the chin and then gently attaching it down the neck
to the chest/sternum area.
• Z Support Strut Placement:
Can either be used in addition to the “A Frame” or instead
of the “A Frame”. Can be positioned with the “corner” of the
Z towards the chin, or with the “corner” of the Z towards the
ear. Can be used unilaterally. Position the Z-Support Strut
WRVLWÀDWDJDLQVWWKHMDZ±WKHVWUXWVKRXOGEHPRXOGHGDQG
VKDSHGE\KDQGWRFXVWRPLVHWKHVKDSHDQG¿W
• Standard and Wide Support Strut Placement:
These can be used in addition to or instead of the A
frame or Z Support Struts. These straight struts can offer
additional lateral (side) Support, extra Support at the back,
RUFDQEHXVHGWRPDNHDPRGL¿HG³$)UDPH´VKDSHDWWKH
front. They need to be heat moulded to optimise Support
and comfort.
Fitting Instructions (continued)
HeadUp Support Strut Position Options

• A-Frame Centre front to prevent head drop
10 HeadUp Collar Instruction Manual
Commonly Used Support
6WUXW&RQ¿JXUDWLRQV
1
• A-Frame with single Z-Support Strut to resist head drop with rotation or side head tilt
2

11HeadUp Collar Instruction Manual
• A-Frame with Z-Support Strut over shoulder and behind ear to address head
GURSZLWKVLJQL¿FDQWVLGHÀH[LRQ
3
• A-frame with bilateral mandibular Z-Support Struts to provide increased head lift whilst
OLPLWLQJURWDWLRQDQGVLGHÀH[LRQZKLOVWUHGXFLQJFKLQORDG
4
• Bilateral Z-Support Struts to resist head drop with reduced chin pressure
(load transferred to inferior mandible)
5

12 HeadUp Collar Instruction Manual
• Bilateral Wide Support Struts only to resist head drop
6
• Bilateral Wide Support Struts with Bilateral mandibular Z-Support Strut placement for
increased resistance to head drop
7
• Bilateral posterior placement of Standard Support Struts to limit cervical hyper extension
8

13HeadUp Collar Instruction Manual
Removing the HeadUp Collar
• Step 1 – Separate the hook and loop fastening closure at the back of the HeadUp Collar.
• Step 2 – Stretch apart the two free HeadUp Collar edges and draw the HeadUp Collar forward
while easing any Support Struts away from the head and neck.
• Step 3±0RYHFKLQSUR¿OHGRZQDQGDZD\IURPXVHU¶VFKLQWRFRPSOHWHUHPRYDO
+HDG8S6XSSRUW6WUXWVGRQRWQHHGWREHUHPRYHGXQOHVVIRUZDVKLQJRU¿WPRGL¿FDWLRQ)RUTXLFN
UHPRYDOLWLVQRWQHFHVVDU\WRGHWDFKWKH+HDG8S6XSSRUW6WUXWV¿UVW
When to Consult a Healthcare Professional
The HeadUp Collar should be removed if any of the following issues are experienced:
• Discomfort • Skin irritation • light-headedness
If any continued adverse symptoms are experienced following use of the HeadUp Collar, please
FRQWDFWWKHPHGLFDOWHDPWUHDWLQJ\RX%HIRUHPDNLQJDQ\FKDQJHWRWKH¿WRU6XSSRUWOHYHORIWKH
HeadUp Collar, ensure that you have read in full HeadUp instructions for use. If in doubt, please
refer to your medical team treating you.
Care and Cleaning Instructions
1RVSHFL¿FPDLQWHQDQFHRIWKH+HDG8S&ROODULVUHTXLUHG
The user should visually inspect the integrity of the HeadUp Collar and its Support Struts before
each use.
Do not use if any damage is apparent: –
replacement parts can be purchased from the Talarmade website.
Periodically the HeadUp Collar assembly, which is worn next to the skin (Fig.1), will require washing.
$OO+HDG8S6XSSRUW6WUXWV)LJVKRXOGEHUHPRYHG¿UVW
Refer to the Fitting Instructions to re-apply the HeadUp Collar and Support Struts after washing.
If machine-washing the HeadUp Collar, use the “delicates” cycle setting at low temperature (30
degrees Celsius) and a low spin speed. Leave to air dry.
Do not use bleach. Do not tumble dry.
Do not iron any part of the HeadUp Collar or the Support Struts.
Do not machine wash the HeadUp Support Struts.
If required, hand-wash Support Struts separately from the HeadUp Collar using lukewarm water
with a gentle detergent only and leave to air dry.

14 HeadUp Collar Instruction Manual
Replacement Parts
Item No. Item Description Fits Size UOM GTIN
HU-RAF/2S Small 'A' Frame - Medium Support 2mm Small EACH 5055204345254
HU-RAF/3S Small 'A' Frame - Firm Support 3mm Small EACH 5055204345261
HU-RAF/2 'A' Frame - Medium Support 2mm Med / Large EACH 5055204324945
HU-RAF/3 'A' Frame - Firm Support 3mm Med / Large EACH 5055204324952
HU-RSS/2S Small Standard 8mm Strut - Medium Support 2mm Small EACH 5055204345292
HU-RSS/3S Small Standard 8mm Strut - Firm Support 3mm Small EACH 5055204345308
HU-RSS/2 Standard 8mm Strut - Medium Support 2mm Med / Large EACH 5055204324983
HU-RSS/3 Standard 8mm Strut - Firm Support 3mm Med / Large EACH 5055204324990
HU-RWS/2S Small Wide 16mm Strut - Medium Support 2mm Small EACH 5055204345315
HU-RWS/3S Small Wide 16mm Strut - Firm Support 3mm Small EACH 5055204345322
HU-RWS/2 Wide 16mm Strut - Medium Support 2mm Med / Large EACH 5055204325003
HU-RWS/3 Wide 16mm Strut - Firm Support 3mm Med / Large EACH 5055204325010
HU-RZS/2LS Small 'Z' Strut - Medium Support 2mm - Left Side Small EACH 5055204345339
HU-RZS/2RS Small 'Z' Strut - Medium Support 2mm - Right Side Small EACH 5055204345346
HU-RZS/3LS Small 'Z' Strut - Firm Support 3mm - Left Side Small EACH 5055204345353
HU-RZS/3RS Small 'Z' Strut - Firm Support 3mm - Right Side Small EACH 5055204345360
HU-RZS/2L 'Z' Strut - Medium Support 2mm - Left Side Med / Large EACH 5055204325027
HU-RZS/2R 'Z' Strut - Medium Support 2mm - Right Side Med / Large EACH 5055204325034
HU-RZS/3L 'Z' Strut - Firm Support 3mm - Left Side Med / Large EACH 5055204325041
HU-RZS/3R 'Z' Strut - Firm Support 3mm - Right Side Med / Large EACH 5055204325058
Item No. Item Description UOM GTIN
HU-RFR HeadUp Component Pouch EACH 5055204324976
HU-RFC/S HeadUp Snood Fabric Collar - Small EACH 5055204345278
HU-RFC/M HeadUp Snood Fabric Collar - Medium EACH 5055204324969
HU-RFC/L HeadUp Snood Fabric Collar - Large EACH 5055204345285
Spares and Accessories
For spares and accessories please visit shop.talarmade.com

HeadUp Kit Size Guide
Neck Circumference
Product Code Description (cm) (inches) Device
,GHQWL¿HU
HUC/S HeadUp Collar - Small 33 - 40 13 - 16 5055204340587
HUC/M HeadUp Collar - Medium 38 - 44 15 - 17.5 5055204324938
HUC/L HeadUp Collar - Large 43 - 51 17 - 20 5055204340594
15HeadUp Collar Instruction Manual
Additional Guidance and Training
Disposal
Terms and Conditions
For additional guidance and training resources please visit www.talarmade.com
+HDG8S&ROODU)LWWLQJ,QVWUXFWLRQV9LGHRLVDYDLODEOHWRYLHZSOHDVHscan the QR Code below:
The disposal and recycling of used devices and packaging must comply with the applicable legal
regulation in each country.
For terms and conditions please visit www.talarmade.com

ART-0029-003
Contact Information
Distributed by
Authorised Representative:
3LHGUR,QWHUQDWLRQDO%9
Jan van der Heydenstraat 18-20,
2665 JA Bleiswijk, The Netherlands
Address:
Talar Made Ltd. Springwood House,
)R[ZRRG:D\&KHVWHU¿HOG
United Kingdom. S41 9RN
Tel: [phone]
Fax: [phone]
Web: www.talarmade.com
Email: [e-mail]
or for more information:[e-mail]