GEBRAUCHSANWEISUNG / INSTRUCTIONS FOR USE
EN
Instrumente / Instruments
This document is has German and English sections.
However to make it easier to follow, the German section
has been removed.
■ INTENDED USE:
This IFU describes the use of the instruments of Advanced Medical Technologies AG. This IFU replaces the IFU´s X-027, X-028, X-029, X-030 and X-034.
■ GENERAL DESCRIPTION:
The instruments were especially designed to facilitate the preparation of the disc
space for an interbody fusion or the insertion of AMT implants. Special importance was attached to function and safety. AMT instruments must not be used
with components of other manufacturers.
■ AREA OF VALIDITY
The instruction for use applies to all instruments of AMT.
■ AUTHORISED IMPLANTS:
All implants of AMT.
The article numbers of the implants can be extracted out of the according surgical technique.
ART: REF X-006 German, REF X-006E English (OUS), REF X-006U
English (USA)
ART2: REF X-036 German, REF X-036E English (OUS), REF X-036U
English (USA)
FUSE: REF X-032 German, REF X-032E English (OUS), REF X-032U
English (USA)
LOOP: REF X-009 German, REF X-009E English (OUS), REF X-009U
English (USA)
SHELL: REF X-008 German, REF X-008E English (OUS), REF X-008U
English (USA)
WAVE: REF X-007 German, REF X-007E English (OUS), REF X-007U
English (USA)
■ INDICATIONS:
The AMT instruments are intended for preparation and/or distraction of the disc
space prior to an interbody fusion or use in combination with the insertion of
AMT implants only. The indications of these products can be extracted out of the
instruction for use of the according implants.
ART/ART2: REF X-002
FUSE: REF X-033
LOOP: REF X-005
SHELL (coated and uncoated): REF X-004
WAVE (coated and uncoated): REF X-003
■ CONTRAINDICATIONS:
The AMT instruments are intended for preparation and/or distraction of the disc
space for an interbody fusion or use in combination with the insertion of AMT
implants only. The contraindications of these products can be extracted out of
the instruction for use of the according implants.
ART/ART2: REF X-002
FUSE: REF X-033
LOOP: REF X-005
SHELL (coated and uncoated): REF X-004
WAVE (coated and uncoated): REF X-003
■ POSSIBLE ADVERSE EFFECTS:
No function of an instrument by wear or defect. Wrong use of instruments or use
of defect instruments might cause a defect of important anatomical structures or
implants. Therefore, please assure that instruments are used correctly and are
not defect.
■ OPERATIVE PRECAUTIONS:
The surgeon must be absolutely familiar with general operative technique and
the necessary instruments. The operational procedure can be read in the according surgical technique.
ART: REF X-006 German, REF X-006E English (OUS), REF X-006U
English (USA)
ART2: REF X-036 German, REF X-036E English (OUS), REF X-036U
English (USA)
FUSE: REF X-032 German, REF X-032E English (OUS), REF X-032U
English (USA)
LOOP: REF X-009 German, REF X-009E English (OUS), REF X-009U
English (USA)
SHELL: REF X-008 German, REF X-008E English (OUS), REF X-008U
English (USA)
WAVE: REF X-007 German, REF X-007E English (OUS), REF X-007U
English (USA)
■ PACKAGING:
All the AMT instrumentation is supplied in special containers (kits) or single
packed in plastic bags. The kits must be closed and sealed. The packaging must
be intact on receipt. If the kit-on-deposit system is used, the completeness of the
kit must be carefully checked. New instruments are provided packed in a sealed
plastic back, non-sterile. The presence and condition of all components should
be checked intensively before use. Storage conditions must enable maintenance
of the integrity of the implants, associated ancillary instruments and their respective packaging. Damaged kits or components must not be used. Please also re-
fer to the instructions for cleaning and re-sterilisation below.
■ COMPLAINTS:
Any healthcare professional (e.g. a surgeon using a product) who has a complaint or who is dissatisfied with the quality, identification, reliability, safety, efficacy and/or performance of the instruments should notify AMT or, where applicable, the distributor. In the event of a serious incident or risk of a serious incident liable to result in, or to have resulted in, the death or serious deterioration in
the state of health of a patient or user, AMT (or the distributor) should be notified
as soon as possible by telephone, fax or letter. All complaints should be accompanied by the product name(s), REF, LOT and the description of the incriminated component(s). The person formulating the complaint should state his
name, address, and the nature of the complaint, giving as many details as possible, and state the required response.
■ REPROCESSING / STERILIZATION:
Fundamental points
All instruments are to be cleaned, disinfected and sterilized prior to each application. This is required as well for the first use after delivery of the unsterile instruments because all instruments will be delivered unsterile, but free from any
manufacturing impurities (cleaning and disinfection after removal of the protective packaging; sterilization after packaging). An effective cleaning and disinfection is an indispensable requirement for an effective sterilization of the instruments.
You are responsible for the sterility of the instruments. Therefore, please ensure
that only sufficiently device and product specifically validated procedures will be
used for cleaning, disinfection, and sterilization, that the used devices (disinfector, sterilizer) will be maintained and checked regularly, as well as that the validated parameters will be applied for each cycle.
Please pay attention to avoid a higher contamination of the complete instrument
tray during application. Keep contaminated instruments separately and don’t put
them back into the instrument tray. The time between the use of the instruments
and the cleaning must not be longer than two (2) hours respectively the impurities must not dry up. Clean/disinfect the contaminated instruments and put them
back into the instrument tray. Afterwards sterilize the complete instrument tray
including all instruments.
Additionally, please pay attention to the legal provisions valid for your country as
well as to the hygienic instructions of the doctor´s practice or of the hospital.
This applies particularly to the different guidelines regarding the inactivation of
prions.
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Cleaning and disinfection
Basics
If possible, an automated procedure (disinfector) should be used for cleaning
and disinfection of the instruments. A manual procedure – even in case of application of an ultrasonic bath – should only be used if an automated procedure is
not available; in this case, the significantly lower efficiency and reproducibility of
a manual procedure has to be considered.
In both cases a pre-treatment is necessary.
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Pre-treatment
Please clean the device until there is no visual contamination of the instruments
directly after application (within a maximum of 2 h).
For this use only running water or a disinfectant solution; the disinfectant should
be aldehyde-free (otherwise fixation of blood impurities), possess a fundamentally approved efficiency (for example DGHM or FDA approval or CE marking),
be suitable for the disinfection of instruments and be compatible with the instruments (see chapter “material resistance“). For manual removal of impurities only
a soft brush or a clean soft tissue is to be used, in no case metal brushes or
steel wool.
Rinse all lumens five (5) times by application of a single-use syringe (minimum
volume 10ml). Special care has to be taken to the following instruments: REF
AI-101 / 102 / 103 / 110 / 111 / 106 / 107.
Please consider, that the disinfectant used in the pre-treatment step serves only
the personal`s safety, but cannot replace the disinfection step – after cleaning –
later to be performed.
Automated cleaning/disinfection (disinfector/WD)
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Pay attention to following points during selection of the disinfector:
fundamentally approved efficiency of the disinfector (for example
DGHM or FDA approval or CE marking according to EN ISO 15883)
possibility for an approved program for thermal disinfection (at least
10 min at 93 ° C or A0 value > 3000; in case of chemical disinfection
danger of remnants of the disinfectant on the instruments)
fundamental suitability of the program for instruments as well as suf-
ficient rinsing steps in the program
postrinsing only with sterile or low contaminated water (max. 10
germs/ml) as well as low endotoxin contaminated water (max. 0.25
endotoxin units/ml), for example purified water/highly purified water
(this water quality can be reached with a reverse osmosis water
process)
only use of filtered air for drying
regularly maintenance and check/calibration of the disinfector
REF X-031 LOT 10355U
GEBRAUCHSANWEISUNG / INSTRUCTIONS FOR USE
Instrumente / Instruments
Pay attention to following points during selection of the cleaning detergent:
fundamental suitability for the cleaning of instruments made of steel
or plastic material
additional application – in case of non-application of a thermal disin-
fection – of a suitable disinfectant with approved efficiency (for example DGHM or FDA approval or CE marking) compatible to the
used cleaning detergent
compatibility of the used detergents with the instruments (see chap-
Pay attention to the instructions of the detergent manufacturers regarding concentration and soaking time.
Procedure:
The fundamental suitability of an effective automated cleaning and disinfection
was demonstrated by an independent accredited test laboratory by application
of the disinfector G 7836 GD (thermal disinfection,Miele & Cie. GmbH & Co.,
Gütersloh) and the cleaning detergent Neodisher medizym (Dr. Weigert GmbH
& Co. KG, Hamburg). The specified procedure was considered.
Manual cleaning and disinfection
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Pay attention to following points during selection of the cleaning and disinfection
detergents:
Combined cleaning/disinfection detergents should not be used.
Pay attention to the instructions of the detergent manufacturers regarding con-
centration and soaking time. Please use only freshly prepared solutions as well
as only sterile or low contaminated water (max. 10 germs/ml) as well as low endotoxin contaminated water (max. 0.25 endotoxin units/ml), for example highly
purified water (this water quality can be reached with a reverse osmosis water
process), and filtered air for drying, respectively.
Procedure: Cleaning
ter “material resistance“)
1. Disassemble the instruments (see also chapter “special aspects”).
Thoroughly clean the devices from any debris.
2. Transfer the disassembled instruments in the disinfector. Pay attention that the instruments have no contact).
Connect all lumens of the instruments by use of a suitable rinsing
adapter to the rinsing port of the disinfector.
3. Start the program.
4. Disconnect and remove the instruments of the disinfector after end of
the program.
5. Check and pack the instruments immediately after the removal (see
chapters “check“, “maintenance“, and ”packaging“, if necessary after
additional post-drying at a clean place).
fundamental suitability for the cleaning and disinfection of instru-
ments made of steel or plastic material
in case of application of an ultrasonic bath: suitability of the cleaning
detergent for ultrasonic cleaning (no foam development)
application of a disinfectant with approved efficiency (for example
DGHM or FDA approval or CE marking) compatible with the used
cleaning detergent
compatibility of the used detergents with the instruments (see chap-
ter “material resistance“)
1. Disassemble the instruments.(see also chapter “special aspects”).
2. Soak the disassembled instruments for the given soaking time in the
cleaning solution so that the instruments are sufficiently covered (if
necessary assist by ultrasonic treatment or careful brushing with a
soft brush). Pay attention that there is no contact between the instruments.
Rinse all lumens of the instruments five times at the beginning and at
the end of the soaking time by application of a single-use syringe
(minimum volume 10 ml) and of a suitable rinsing adapter.
3. Then, remove the instruments of the cleaning solution and post-rinse
them at least three times with water. Thoroughly clean the devices
from any debris.
Rinse all lumens of the instruments five times by application of a single-use syringe (minimum volume 10 ml) and of a suitable rinsing
adapter.
4. Check the instruments (see chapters “check“ and “maintenance“).
Disinfection
5. Soak the disassembled instruments for the given soaking time in the
disinfectant solution so that the instruments are sufficiently covered.
Pay attention that there is no contact between the instruments.
Rinse all lumens of the instruments five times at the beginning and at
the end of the soaking time by application of a single-use syringe
(minimum volume 10 ml) and of a suitable rinsing adapter.
6. Then, remove the instruments of the cleaning solution and post rinse
them at least three times with water.
Rinse all lumens of the instruments five times by application of a single-use syringe (minimum volume 10 ml) and of a suitable rinsing
adapter.
7. Pack the instruments immediately after the removal (see chapter
“packaging“, if necessary after additional post drying at a clean
place).
The fundamental suitability of an effective cleaning and disinfection was demon-
REF X-031 LOT 10355U
strated by an independent accredited test laboratory by application of the cleaning detergent Cidezyme/Enzol and the disinfectant Cidex opa (Johnson & Johnson GmbH, Norderstedt). The specified procedure was considered.
Check
Visually inspect all instruments after cleaning or cleaning/disinfection, respectively, on corrosion, damaged surfaces, chippings and impurities. Do not further
use damaged instruments (limitation of the numbers of re-use cycles see chapter “reusability“). Still dirty instruments are to be cleaned and disinfected again.
Maintenance
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Assemble disassembled instruments again (see specific instructions).
If possible do not use instrument oils. In case of application use only instrument
oils (white oil) admitted to steam sterilization considering the maximum possible
sterilization temperature and with approved biocompatibility.
Packaging
Please insert the cleaned and disinfected instruments in the corresponding sterilization tray.
Please pack the instruments in single-use sterilization packagings (single or
double packaging) and/or sterilization containers, which fulfill the following requirements:
EN ISO 11607 / ANSI AAMI ISO 11607
suitable for steam sterilization (temperature resistance up to at least
141 ° C (286 ° F), sufficient steam permeability)
sufficient protection of the instruments as well as of the sterilization
packagings to mechanical damage
regular maintenance according to the instructions of the manufactur-
er (sterilization container)
The sets must be packed in respective sealed sterilization cases. Sterilization
wraps do not provide sufficient protection.
Sterilization
For some instruments special aspects are necessary, please consider
chapter "special aspects"!
Please use for sterilization only the listed sterilization procedures; other sterilization procedures must not be applied.
Steam sterilization
fractionated vacuum / pre-vacuum (at least three (3) cycles) proce-
dure or gravity procedure1 (not applicable for ART products) (with
sufficient product drying)
steam sterilizer according EN 13060 / ANSI AAMI ST 79 respectively
EN 285 / ANSI AAMI ST 79
validated according to EN ISO 17665 / ANSI AAMI ISO 17665 (valid
commissioning and product specific performance qualification)
minimum sterilization temperature 132 ° C (270 ° F) plus tolerance (-
0° / +2 °) according to EN ISO 17665 / ANSI AAMI ISO 17665)
sterilization time (exposure time at the sterilization temperature) at
least 8 min2 at 132 ° C (270 ° F) plus tolerance (-0° / +2 °)
a dry time of 20 min is sufficient for instruments of this kind
1
The less effective gravity procedure must not be used in
case of availability of the fractionated vacuum procedure
2
An extended sterilization time (for example in Germany
18 min) to reduce the risk of prion contamination. Please
refer to your national requirements.
The above mentioned sterilization cycles are not considered by the United
States Food and Drug Administration (US FDA) to be standard sterilization cycles. Users should only use sterilizers and accessories (such as sterilization
wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature).
The fundamental suitability of an effective steam sterilization was demonstrated
by an independent accredited test laboratory by application of the steam sterilizer EuroSelectomat (MMM Münchener Medizin Mechanik GmbH, Planegg) and
the fractionated vacuum procedure as well as of the steam sterilizer Systec V150 of Systec GmbH Labor-Sytemtechnik (Wettenberg) and the gravity procedure. The specified procedure was considered.
The flash sterilization procedure must not be used.
Do not use dry heat sterilization, radiation sterilization, formaldehyde and ethy-
lenoxide sterilization, as well as plasma sterilization.
Storage
Please store the instruments after sterilization in the sterilization packaging at a
dry and dust-free place.
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