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R ing P l acementFontanelles & Sutures
Ce rv i ca l Sp ine Pos i t i on ing
P in Cons ide ra t i ons
P in Inse r t i on
Fo l l ow -Up Ca re
A pre-application CT scan is strongly recommended to assess the skull thickness below the skull equator. Measurements should be obtained from a cut obtained on a line from 0.5 to 1.0 cm above the orbital rim and 1.0 to 1.5 cm below the maximum bi-parietal diameter.
The number of pins to be applied varies depending on the skull thickness of the child and the number of available pin sites. A suggested guideline for the number of pins based on age follows.
The primary physician (1) is responsible for safely positioning the head and neck. Two assistants (2 & 3) apply the halo pins simultaneously with equal force in opposite directions while another assistant (4) prevents ring migration and ensures symmetrical application.
Sku l l Th i ckness
Skull thickness in the "safe" frontal and parietal areas has been shown to be inconsistent with high variability up until 12 years of age. After 12, skull thickness may be more proportional to skeletal growth, and by 16 years of age, adult skull thickness (8-12 mm) is reached.
Three or four individuals are recommended for positioning the patient and application of the halo, while maintaining a neutral cervical position.
“Safe” Zones for pin placement (dependent upon results of CT scan), avoiding anterior nerves, frontal sinuses, and temporalis muscles.
Anterior pins should be placed 0.5 to 1.0 cm above the orbital rim and posterior pins should be placed 1.0 to 1.5 cm below the equator of the skull to avoid migration or dislodgment of the halo.
Pin sites should be prepared by shaving and then cleaning with an antiseptic swab.
Pediatric halo applications should be completed under general anesthetic. To minimize pin discomfort post application, a local anesthetic (without epinephrine) should be applied through the ring to selected pin sites.
Ring position should be carefully controlled to ensure consis-tent spacing between ring and skull. Pins should be applied with equal torque in opposite directions (diagonally) simultaneously.
Insertion Torque:
- 1 in.lb/yr to age 5
- maximum 6 in.lb/pin for ages 6+
(1) Pins applied to finger-tightness.
(2)Torque wrenches are then used for final tightening.
Pins retightened after 15 minutes to account for stress relaxation at pin-bone interface.
Final torque check/pin retightening after 24 hrs.
Meticulous follow-up care is recommended. Schedule frequent follow-up visits to ensure pin care is appropriate. Pin site infections may be treated with oral antibiotics; loose pins should be replaced and alternate sites selected.
Cranial sutures should be noted and avoided in pin placement, particularly the posteriorly located lambdoidal suture.
By increasing the number of pins used, lower forces can be magnified over a greater surface for fixation.
3 mm
8 mm
Appropriate padding should be used to maintain cervical position. The Occian® AirWay PAD™ is pictured.
Halo immobilization is not recommended in any child under 18 months of age or with open fontanelles. The Papoose® provides non-invasive mobilization for the youngest patients; contact Össur for more information.
For detailed vest application instructions, please refer to opposite side per adult halo application instructions.
LambdoidalSuture
Closes between 6 - 12 months
Closes at approx. 18 months
Sagittal Suture
Coronal Suture
UNIQUE FEATURES of the Pediatric Skull GUIDELINES for Pediatric Application
Due to disproportionate growth rates in the cephalic diameter compared with chest wall diameter, the cervical spine may be in an exaggerated position of flexion when the child is lying supine.
Avoid resting the halo ring on the pinna of the ear
The skull sutures are highly mobile until fontanelle closure is complete and remain slightly mobile until 24-30 months.
Neutral cervical position is best achieved by aligning the external auditory meatus with the sternum.
In general, this is the most appropriate position of the cervical spine within the halo apparatus.
Availablein two sizes: P2 P3
It should be noted that to correctly choose the necessary number of pins and application torque, they must be determined based on patient parameters.
<4 yrs = 8 - 10 pins5-10 yrs = 6 - 8 pins>10 yrs = 4 - 6 pins
Össur Americas Össur Canada Össur APAC27051 Towne Centre Drive 2150 – 6900 Graybar Road 2F, W16 BFoothill Ranch, CA 92610, USA Richmond, BC No. 1801 Hongmei RoadTel: +1 (949) 382 3883 V6W OA5 , Canada 200233, Shanghai, ChinaTel: +1 800 233 6263 Tel: +1 604 241 8152 Tel: +86 21 6127 [email protected] [email protected]
Össur NordicÖssur UK Ltd P.O. Box 67 Össur AustraliaUnit No 1, S:Park 751 03 Uppsala, Sweden 26 Ross Street,Hamilton Road Tel: +46 1818 2200 North ParramattaStockport SK1 2AE, UK [email protected] NSW 2151 AustraliaTel: +44 (0) 8450 065 065 Tel: +61 2 [email protected] Össur Iberia S.L.U [email protected]
Calle Caléndula, 93 -Össur Europe BV Miniparc III Össur South AfricaDe Schakel 70 Edificio E, Despacho M18 Unit 4 & 55651 GH Eindhoven 28109 El Soto de la Moraleja, 3 on LondonThe Netherlands Alcobendas Brackengate Business ParkTel: +800 3539 3668 Madrid – España BrackenfellTel: +31 499 462840 Tel: 00 800 3539 3668 7560 Cape [email protected] [email protected] South Africa
[email protected] Tel: +27 0860 888 123Össur Deutschland GmbH [email protected] 11A Össur Europe BV – Italy50226 Frechen Via Baroaldi, 29Deutschland 40054 Budrio, ItalyTel: +49 (0) 2234 6039 102 Tel: +39 05169 [email protected] [email protected]
Össur hf.Grjótháls 1-5110 Reykjavík, IcelandTel: +354 515 1300Fax: +354 515 1366
Quick Reference Guide
LIL ANGEL® & RESOLVE® HALO & ÖSSUR HALO
www.ossur.com ©Copyright Össur 2017 Rev. 4QRC 0017 / 1140_001_EN
MRMRI Conditional
AUTO CLAVE
FOR PERFORMING EMERGENCY CPRInstructions are provided on the anterior portion of the vest. For additional information see written instructions below:
Detach waist straps1 Place hand on upper portion of vest and bend lower section towards chest
2
3 Perform CPR
Apply local anesthetic (without epinephrine!) to selected pin sites. Insert pins and hand tighten. The order of pin tightening can be accomplished by one of two methods:
a. Opposing pair- pins opposite to each other are tightened simultaneously
b. Posterior-anterior- two posterior pins are tightened followed by two anterior
pins
Lean on anterior vest while tightening anterior vest-upright connectors. Log roll and tighten posterior vest-upright connectors.
Note: Superstructure can be adjusted to allow for full flexion/extension, capital flexion/extension, distraction/compression, and anterior/posterior translation. Please see the ReSolve® Halo Vest technical manual for full instructions.
Use c-spine precautions. Remove pillows from behind the head. Maintain c-spine alignment by supporting the patient’s head off the end of the table using a head positioner or by using a bolster. Ensure that there is adequate clearance for posterior portion of the ring at the back of the head.
2
3 (Optional) Roll a stockinette liner up from the patient's waist to under arms.
4 Select appropriate pin sites based on safe zone recommendations. Shave the patient’s head at the posterior pin sites.
PRE - APPLICATION
With patient supine for measurements, measure head across greatest circum-ference of the skull (about 1cm above the ears) to deter-mine ring size.
1
0,5-1 cm
Measure patient's chest circumference at the xyphoid process to determine vest size.
VEST
6 Position the anterior vest on patient’s chest so that the lateral superior edge is just below the clavicles.
7
8 Thread shoulder straps through shoulder loops. Tighten and secure making sure the plastic shoulder stabilizers are underneath the straps.
Note: All straps should be tightly fastened without causing patient excessive discomfort.
RINGmay require application BEFORE vest.
S U P E R S T R U C T U R E R O D S
10 Put on gloves and use antiseptic swabs to clean pin site areas.
11 Position ring on head with the positioning pins provided.
9 Secure waist stabilizers by lining up corresponding holes and applying threaded knob.
12
13
FINAL CHECKLIST:
All bolts tight.
Shoulder and waist straps secure.
Anterior vest threaded knobs in place and tight.
Parallel planes with ring and transverse rod.
5 Logroll or carefully raise entire thorax and place posterior vest on patient. Return to supine position.
14 Tighten pins first to 4 in-lbs and then to 6 in-lbs or 8 in-lbs us-ing the same order of pin tightening, as applicable per the in-cluded torque driver. Either the pre-set torque driver or Össur adjustable torque driver (575S) may be used to tighten pins.
APPLICATION INSTRUCTIONS for Össur Halo Traction Systems
These guidelines pertain to patient’s wearing a ReSolve®
Halo ring (final configuration may differ from images shown)and are intended only as a quick reference guide. Complete instructions for halo application can be found in the ReSolve
® Halo Vest and
ReSolve®
Halo Ring and Össur Halo Ring IFU.
Three people are recommended for application. Instructions do not supercede physician’s orders or hospital protocol.
SINGLE USE ONLY For your convenience this product has been supplied sterile.Sterility is guaranteed unless individual package is opened or damaged
MR Conditional - When used with Titanium-tipped skull pins, this medical device has been found to be MR Conditional: Safe at 1.5-Tesla based on the ASTM F2119-07 standards.
When used with Ceramic-tipped skull pins, this medical device has been found to be MR Conditional: Safe at 3-Tesla based on the ASTM F2119-07 standards.
Caution: The Halo system should not be used under any conditions where pressure to the skull would not be tolerated. For pediatric or geriatric patients with compromised bone integrity a multiple-pin, low-torque technique may be indicated. Order additional pins and adjustable torque wrench as needed.
Wrap waist stabilizers and waist straps around patient and insert them through the loops on the anterior vest. Tighten waist straps and fasten with hook piece.
EN - Caution: This product has been designed and tested as a single use product, and is not intended for multiple use. In addition to increasing the risk of infection, used product components may contain small unnoticeable defects that may lead to non-optimal performance, and even mechanical failure. If any problems occur with the use of this product, immediately contact your medical professional.
Measure patient's chest circumference at the xyphoid process to determine the posterior vest size. Measure the patient’s sternal length to determine anterior vest size and adjust anterior vest accordingly.
Apply and tighten threaded knob to secure anterior height. Caution: You must apply and tighten the threaded knob to secure the height of the anterior vest shell. Failure to do so may result in bodily injury to the patient.
All components used for pin application are provided sterile.
1-1,5 cm
15 Remove positioning pins and then apply and finger-tighten lock nuts.
Approximately 30 minutes after application, loosen lock nuts, check pin torque, and retighten lock nuts. Re-check torque once more at 24-36 hours post applica-tion. Retighten skull pins with torque driver as needed.
16
17 Ensure upright rods are attached to the vest and slightly loosened.
18 Align and attach the ring attachment disk and distraction assembly to the halo ring. Make sure the post on the attachment disk is placed in one of the holes in the “V” portion of the ring.
19 Insert posterior uprights through posterior upright-transverse clamps and tighten. Repeat with the anterior uprights.
20 Tighten distraction assembly clamp.
21
22 Firmly re-tighten shoulder and waist straps as necessary to eliminate gaps and to obtain firm support of vest against sternum.
23
SAFE ZONE
Place ring low and tight on head as shown: (“A”- closed back ring, “B” & “C”- open back ring.) With use of tongs, orient V over ears to fit around base of tongs (“C”), otherwise invert V to allow access to ears (“B”).
A B C
SIZE CHART
Halo Ring Size Head Circumference
Small 43 cm-51 cm (17”-20”)
Standard 51 cm-59 cm (20”-23”)
Large 59 cm-66 cm (23”-26”)
FOR PERFORMING EMERGENCY CPR
Instructions are provided on the anterior portion of the vest. For additional information see written instructions below:
CPR
Unscrew bottom knob1 Detach waist straps2
3 Place hand on upper portion of vest and bend lower section towards chest
4 Perform CPR
