ReSolve Halo Ring

Te c h n i c a l M a n u a l
ReSolve® Halo Ring
ENDo not autoclave – This symbol represents the
warning that this medical device shall not be
subjected to an autoclave.
ENMR conditional – This medical device has been
found to be MR Conditional: Safe at 3-Tesla
based on the ASTM F2119 – 07 standards.
DENicht autoklavieren – Dieses Symbol sagt aus,
dass dieses Medizinprodukt nicht in einem
Autoklav sterilisiert werden darf.
DEBedingt MR-sicher – Dieses Medizinprodukt ist
bedingt MR-sicher: Sicher bei 3 Tesla basierend
auf den ASTM F2119 – 07-Standards.
FRNe pas stériliser à l’autoclave – Ce symbole
représente un avertissement signifiant que ce
dispositif médical ne doit pas être stérilisé à
l’autoclave.
FRCompatible avec la RM – Ce dispositif médical
a été catégorisé comme étant compatible avec
la RM : Sécuritaire à 3 Tesla, conformément aux
normes ASTM F2119 – 07.
ESNo esterilizar en autoclave – este símbolo es
una advertencia de que este producto sanitario
no debe esterilizarse en autoclaves.
ITNon sterilizzare con autoclave – Questo
simbolo rappresenta l’avvertenza che questo
dispositivo medico non deve essere sterilizzato
con autoclave.
ESCondicionado por RM – se ha determinado que
el uso de este producto sanitario está
condicionado por la resonancia magnética: Es
seguro a 3-Teslas según las normas ASTM
F2119 – 07.
ITCompatibilità RM condizionata – Questo
dispositivo risulta compatibile RM
condizionatamente: sicuro a 3 Tesla in base agli
standard ASTM F2119 – 07.
NOIkke autoklaver – dette symbolet reprensenterer
at dette medisinske apparatet ikke skal
autoklaveres.
DAMå ikke autoklaveres – Dette symbol advarer
om, at denne medicinske anordning ikke må
autoklaveres.
NODette medisinske apparatet kan trygt brukes i
MRI – miljø. Trygg ved 3-Tesla basert på ASTM
F2119 – 07 standarder.
SVAnvänd inte autoklav – Denna symbol varnar
för att denna medicinska enhet inte ska
utsättas för autoklav.
DAMR-betinget – Denne medicinske anordning er
defineret som MR-betinget: Sikker ved 3 Tesla
baseret på standarderne
ASTM F2119 – 07.
FIEi saa autoklavoida – tämä symboli on varoitus,
jonka mukaan tätä lääkinnällistä laitetta ei saa
autoklavoida.
SVMR-villkorlig – Denna medicinska enhet har
befunnits vara MR-villkorlig: Säker vid 3-tesla
baserat på ASTM:s standarder F2119 – 07.
ELΜην αποστειρώνετε σε αυτόκαυστο – Το
παρόν σύμβολο αντιπροσωπεύει την
προειδοποίηση ότι το παρόν ιατροτεχνολογικό
προϊόν δεν πρέπει να υποβληθεί σε
αποστείρωση σε αυτόκαυστο.
FIMR-ehdollinen – tämä lääkinnällinen laite on
todettu MR-ehdolliseksi: Turvallinen 3-Teslassa
ASTM F2119 – 07 -standardien perusteella.
ELΜαγνητικός συντονισμός (MR) υπό όρους –
Το παρόν ιατροτεχνολογικό προϊόν έχει βρεθεί
ότι είναι συμβατό με μαγνητικό συντονισμό
(MR) υπό όρους: Ασφαλές στα 3 Tesla βάσει των
προτύπων ASTM F2119 – 07.
NLNiet geschikt voor autoclaaf – Dit symbool is
een waarschuwing dat dit medisch apparaat
niet in een autoclaaf mag worden gesteriliseerd.
PTNão esterilize em autoclave – Este símbolo
representa o aviso de que este dispositivo
médico não deve ser esterilizado em autoclave.
NLMR geschikt – Dit medisch apparaat werd
getest en is MR geschikt: Veilig bevonden bij
3-Tesla op basis van de ASTM F2119 – 07
normen.
JA
加圧滅菌器で処理しないでください – この記
号は、本医療製品を加圧滅菌器で処理しては
いけないことを示します。
ZH 切
勿高压灭菌 – 此标志表示警告：此医疗
设备不得采用高压灭菌。
PTCondicional para RM – Este dispositivo médico
foi considerado condicional para RM: seguro
para exames de 3 Tesla, com base na norma
ASTM F2119 - 07.
KO
가압 멸균하지 마십시오 – 이 기호는 본
의료 장치가 가압 멸균 대상이 아니라는
경고를 표시합니다.
JA
条件付きでMR可能 – 本医療製品はMR可能で
あることが分かっています。ASTM F2119 – 07
標準に基づき3テスラでは安全です。
ZH 条
件性磁共振兼容 – 此医疗设备为条件性
磁共振兼容：依据 ASTM F2119 – 07 标准
在 3 特斯拉下安全。
KO
MR 조건 준수 – 본 의료 장치는 ASTM
F2119 – 07 표준에 따라 MR Conditional:
3-Tesla 안전 기준을 충족하는 것으로
밝혀졌습니다.
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.
2
1
SIZE CHART
3
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")
4 a
1-1,5 cm
5
4 b
6
4
7
closed back ring
open back ring
8
9
10
5
11
ENGLISH
Instructions do not supercede physician’s orders or hospital protocol. The order at which you put the vest and
ring on is left to the physician.
caution: Federal law restricts this device to sale by, or on the order of, a physician.
A complete ReSolve® Halo system includes a ReSolve® Halo Vest used in combination with a ReSolve® Halo
Ring or Össur Halo Ring (open or closed back versions).
Indications For Use
The ReSolve system is recommended for use in traumatic or chronic disorders requiring traction along the
cervical spine to align the vertebral structures (reduce deformities), maintain reduction, or provide stabilization.
Indications include cervical spine trauma or surgery.
Contraindications
The ReSolve system should not be used under any conditions where pressure to the skull would not be tolerated.
When used as part of a traction system (i.e. with weights), the halo should also not be used when the stability of
the cervical spine will not permit traction loads.
This product is for single use only
. For your convenience, this product has been supplied sterile
Sterility is guaranteed unless individual package is opened or damaged. Please follow Össur Sterilization
recommendations if product becomes contaminated or requires re-sterilization.
.
PRE-APPLICATION
1. Lay the patient supine.
2. Measure patient’s head circumference to determine ring size. Measure at the greatest circumference of
the skull (about 1 cm above the ears)(Figure 1). See sizing chart (Figure 2) for correct size halo ring. The
ring should be large enough to allow for cleaning with approximately 1 to 1.5 cm between the ring and
skull. (Figure 3)
3. 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 (option 1)(Figure 4a) or by using a bolster (option 2)
(Figure 4b). Remove pillows from behind the head.
4. Select appropriate pin sites based on “safe zone” recommendations and shave posterior pin sites.
Anterior skull pins should be positioned as low as possible in the lateral one-third area above the eyebrow.
Posterior skull pins should be positioned 1 cm posterior to the tip of the ear (Figure 5).
caution: be careful to avoid the supraorbital ridge, supraorbital nerves, temporalis muscle, temporal bone,
frontal sinus, and/or any possible fracture site.
RING application
All components used for pin application are provided sterile.
1. Maintain c-spine alignment by supporting the patient’s head off the end of the table using a head
positioner (option 1)(Figure 4a) or by using a bolster (option 2)(Figure 4b).
2. Put on gloves.
3. Use antiseptic swabs to clean pin site areas.
4. Position ring on head with the positioning pins. If necessary, move positioning pins to accommodate
access to selected skull pin sites (Figure 6).
5. Check appropriate placement and slope of ring on head (Figure 7). Note: The closed back ring is provided
with a posterior hole to attach to the Össur Universal Halo Adaptor #581 (Mayfield type).
–– Parallel to head to allow perpendicular pin penetration
–– Below largest equator of skull
–– As low as possible without any contact with ears or eyebrows
6. Inject local anesthetic to skull pin sites from either the top or bottom of the ring. You may find it helpful
to hold a pen light up to the ring holes to light the area of pin placement through the halo. Anesthetize
down to the periosteum. Note: Anesthetic without epinephrine should be used in order to avoid necrosing
around the injection site.
7. Patient should close eyes tightly for skull pin application to prevent skin bunching. Thread all skull pins
through halo ring holes until they touch the skin. Then finger tighten all skull pins according to one of the
6
below pin tightening methods. Finally, tighten all skull pins using a torque driver first to 4 in. lbs. and then
to 6 in. lbs. according the same pin tightening method.
note: During pin application, if excessive resistance is felt, the pin may be cross-threaded. Do not force
the pin. Remove the pin, re-align with the threaded hole and apply again. If a sudden drop in torque is
noted, stop and evaluate.
The order of pin tightening can be accomplished by one of two methods; opposing pair method or
posterior-anterior method.
–– Opposing pair: pins opposite to each other are tightened simultaneously (Figure 8). Posterior-anterior:
two posterior pins are tightened followed by the two anterior pins (Figure 9).
* Skull pins should be tightened to 6 in. lbs., as indicated by preset torque driver. If higher or lower torque is
needed, use Össur Adjustable Torque Driver # 575S.
8. Remove positioning pins.
9. Apply and finger-tighten lock nuts. do not use a wrench.
10. After approximately 30 min (or at the end of vest application if halo was applied first) loosen lock nuts,
check skull pin torque, and re-tighten lock nuts. Follow up by checking pin torque 24–36 hours after. Pins
should be maintain a torque setting of 8 in lbs. Retighten skull pins with the torque driver or Adjustable
Torque Driver # 575S as needed.
OPTIONAL/HELPFUL HINTS
traction hoop: Position traction hoop symmetrically on patient and connect to halo on holes not used by
skull pins. The S-hook is then placed through the hole in the top of the traction hoop and used to apply the
appropriate traction load (Figure 10).
J-Tongs: If using Össur J-Tongs in conjunction with the Össur Halo, orient V down to fit around base of tongs
(Figure 11).
aftercare
note: these instructions are directed towards practitioners/physicians applying a halo, and are not intended as patient
care instructions. Refer to Össur Patient Information Manual for patient home hygiene and care instructions.
1. Provide and explain information to patient for daily halo care.
2. Schedule a 24–36 hour follow up visit post-application to check pin tightness and for signs of
complications. Pins should maintain a torque of 8 in lbs. at this time.
3. 3 week visits for liner changes and pin-site inspections should be scheduled. During pin-site inspections,
check for redness, discharge, or other signs of infection.
4. At 4 weeks, pin torque should be maintained to at least 6 in lbs.*
5. At 8 weeks, pin torque should be maintained to at least 4 in lbs. and can remain at that level for the
duration of healing and halo use.*
* These are suggested torques only. Patient’s needs while healing may vary.
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MR
MRI Conditional
©Copyright Össur 2013
TM 0050 Rev. 4