ChM CHARSPINE system Bedienungsanleitung Seite 7

used, e.g.: R or VH202 (symbols are described in the footer of this Instruc-
tions For Use).
f) Sterilization batch number, e.g.: S-XXXXXXX.
g) Device pictogram and information symbols (described in the footer
of this Instructions For Use).
h) Expiration date and sterilization method.
2) Non-sterile product
a) Logo ChM and the address of the manufacturer.
b) Name and size of the device and its catalogue number (REF), e.g.:
3.XXXX.XXX.
c) Production batch number (LOT), e.g. XXXXXXX.
d) Material of the implant (see IMPLANT MATERIAL).
e) NON-STERILE sign - indicates non-sterile product.
f) Device pictogram and information symbols (described in the footer
of this Instructions For Use).
g) The expiration date (for polymeric devices).
7. In addition to the device primary label, an auxiliary label with specific
market requirements of a given area may be placed on the unit package
(e.g. legal requirements of the country in which the device will be distrib-
uted).
8. The package may contain: Instructions For Use and labels to be placed
in a patient' s medical record.
9. Depending on the size or type of the product, the following information
may be marked on its surface: manufacturer' s logo, production batch no.
(LOT), catalogue no. (REF), type of material and device size.
10. Implants should be stored in appropriate protective packagings, in a clean,
dry place with a room temperature and under conditions that provide pro-
tection from direct sunlight.
6 IMPLANT MATERIAL
1. Identification of the materials
1) Depending on the type of material used in integrated metallic elements,
the following symbols may be marked on the device surface:
a) Titanium: symbol (Ti).
b) Tantalum: symbol (Ta).
2) The ChM' s polymeric intervertebral implants are made of biocompatible
PEEK-OPTIMA® (polyetherethereketone), in accordance with ISO 10993
standards and regulations of USP Class VI. The type of material is marked
on the label of the device.
3) The ChM's polymeric intervertebral implants are equipped with in-
tegrated radiopaque markers, made of tantalum in accordance with
ISO 13782/ASTM F560.
4) The TLIF PEEK intervertebral cage and ALIF PEEK locking intervertebral
cages contain integrated elements made of titanium alloy.
5) Percent composition of elements in the implantable materials (max.
values):
a) Titanium alloy according to ISO 5832-3/ASTM F136: | Al:6.75 | V:4.5 |
Fe:0.3 | O:0.2 | C:0.08 | N:0.05 | H:0.015 | Ti:balance.
b) Titanium alloy according to ISO 5832-11/ASTM F1295: | Al:6.5 | Nb:7.5
| Ta:0.5 | Fe:0.25 | O:0.2 | C:0.08 | N:0.05 | H:0.009 | Ti:balance.
6) ATTENTION: Implantable titanium, titanium alloy and/or implantable
cobalt alloy may be used together in the same construct. Never use tita-
nium, titanium alloy and/or cobalt alloy with implantable stainless steel
components in the same construct as it may lead to corrosion and reduc-
tion of mechanical strength of implants.
2. Magnetic resonance compatibility
1) The ALIF PEEK locking intervertebral cages and TLIF PEEK intervertebral
cages, which contain integrated elements made of titanium or titanium
alloy, are conditionally compatible with magnetic resonance imaging.
2) The patient can be scanned safely under the following conditions:
a) static magnetic field of ≤ 3 Tesla,
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