MBM MONDEAL BONE MILL Manual De Instrucciones página 3

Instruction for use for the
MONDEAL BONE MILL (MBM)
Basic information
Basic instructions for the use of MONDEAL Medical Systems GmbH (hereinafter referred to as MONDEAL)
implants and instruments in the fields of orthopedics and osteosynthesis.
It is imperative that all explanations and instructions in this manual are observed and complied with.
Should any uncertainties, discrepancies or questions arise, please therefore contact us before the products are
used or prepared (again).
Information and Symbols on Labels
Item number
Quantities
Batch code
Non sterile
Marking for medical devices in Risk class I
Products
These instructions for use are valid for the "Mondeal Bone Mill" (MBM).
All components are reusable.
The spring-loaded milling mechanism ensures even pressure and minimal effort when turning up to a filling
height of max. 1.5 cm.
Blade cylinder
Item number Description
33-10011 MBM blade cylinder size S, small
33-10021 MBM blade cylinder size M, medium
33-10031 MBM blade cylinder size L, big
The MBM body is made of aluminium with an abrasion- and heat-resistant surface seal. The pressed in ring for
the running surface of the blade cylinder and the blocking blocks are made of biocompatible abrasion-resistant
plastic.
All other components are manufactured from stainless steel (in accordance with ISO 7153-1).
All components of the MBM Bone Mill are placed on the market NON-STERILE and must undergo an
appropriate preparation process prior to first use.
Intended use
The MONDEAL Bone Mill (MBM) and accessories are intended for the manual processing of autologous bone
grafts made from cancellous and/or compact bone. Bone grafts from the following regions are used for this
purpose, depending on the choice of the attending physician: calotte bone, jaw bone, pelvic bone, etc.
Possible complications
Complications that may possibly arise can be caused by
• Inadequate cleaning and sterilization that has not been carried out in accordance with the specifications.
This can lead to discoloration of the surface as well as a limited function of the mechanical parts.
• Insufficient or omitted manual pre-cleaning causes the bone material to be contaminated with non-sterile
bone material from previous applications. This can lead to infections and to treatments using milled bone
grafts failing.
• Corrosion as a result of faulty positioning during ultrasound, in the cleaning and disinfection unit or autoclave
due to residual fluid in the MBM.
• Incorrect insertion and use of the blocking blocks may cause the MBM to become blocked and make milling
impossible.
• Blunt or damaged blade cylinders cause disproportionate, high wear on the MBM's running surfaces for the
blade cylinder.
• Jamming of the press punch due to lack of mobility in the upper MBM body, caused by lack of maintenance
using an appropriate instrument care oil.
• Graft pieces that are too small can lead to jamming if the wrong blade cylinder size is used. Irritation to soft
tissue.
Warnings and precautionary measures
• As the manufacturing company, MONDEAL recommends the user read all available documents thoroughly
before the first use in practice, and contact users who already have experience with this type of treatment
method
• The products mentioned may only be used by specialist medical staff with the appropriate training.
• The product must be handled and stored with care. Damage to or scratches on the instrument may affect
the safety of the product.
• Products damaged by transport, handling in the clinic or other causes may not be used under any
circumstances!
• Use the necessary care when using and storing the products.
Use of original products
All system components have been designed and manufactured for a specific purpose and are therefore finely
harmonized with one another. No component may be modified by the user or replaced by any instrument or
product from a third-party manufacturer, even if it resembles or even exactly matches the size or shape of the
original product. Insufficient quantity or quality of bone mass/substance for stable fixation.
Components of the MBM
The MBM bone mill consists of:
• MBM Bone Mill basic body
• MBM Turning lever
• MBM Cutting cylinder
• Bone collector for MBM
• Locking pieces for MBM
Instruction for Use for MBM – MONDEAL BONE MILL
MONDEAL Medical Systems GmbH
IMPORTANT! READ CAREFULLY BEFORE USE; KEEP SAFE TO REFER TO AT A LATER POINT
Manufacturer
Date of manufacture
Caution
Consult instructions for use
Size
approx. 2.0 mm
approx. 3.0 mm
approx. 4.0 mm
Page 3 of 24
Returns
Any product return shipments may only be sent back to us after disinfection/sterilization has been performed
which is clearly evident (appropriate packaging with sterility indicators, decontamination certificate, etc.)
The relevant ordinance on hygiene and commercial premises must be adhered to.
Guarantee
MONDEAL delivers only tested and fault-free products to its customers. All our products are designed and
manufactured to meet the highest quality standards.
MONDEAL, as the manufacturer of the products, excludes all warranty claims, and assumes no liability for direct
or consequential damages, resulting from:
•
Unintended use.
•
Improper use, application or handling.
•
Improper preparation and sterilization.
•
Not observing the instructions for use.
MBM assembly instructions
Insertion of the blade cylinder. Attach turning lever to the shaft
Completely insert the rotary of the blade cylinder
cylinder. 1. Open the locking mechanism.
2. Slide the lever onto the shaft
as far as it will go.
3. Close the locking
Screw the bone collector into the The MBM is ready to use.
blade cylinder.
Spring-loaded mechanism is After the milling process
blocked due to the blocking 1. Place the MBM on the bone
blocks. collector. Do not release the
bone mill
2. Remove the turning lever.
3. Pull the base body of the
MBM upwards.
MBM disassembly instructions
Disassembly of the bone mill is performed in the reverse sequence of the MBM assembly instructions
Never loosen let alone open any other screws or connecting parts on the MBM bone mill. This would impair
functionality, and the guarantee of the MBM bone mill would be voided.
Notes on cleaning, disinfection and sterilization
All implants, instruments and containers of MONDEAL systems that have been delivered NON-STERILE must
be cleaned, disinfected and sterilized before each use; this also applies to the first use after delivery (after
removal of the protective packaging for transport).
Effective cleaning and disinfection are essential requirements for effective sterilization.
A mechanical process must be uded for cleaning and disinfection.
For a description of the validated procedure for cleaning, disinfection and sterilization, see
"Preparation instructions, cleaning, disinfection and sterilization"
Additional information
You can request further information on the products (e.g. surgical techniques, care, cleaning, disinfection and
sterilization) from your contact person. In addition, you will find all the information on the Internet at
www.mondeal.de
MONDEAL Medical Systems GmbH
Am Gewerbering 7
78570 Mühlheim a.d. Donau
Tel.+49 7463 99307 0
Fax: +49 7463 99307 33
Email: mail@mondeal.de
EN
Remove the turning lever from
the shaft of the blade cylinder
1. Open the locking mechanism.
2. Slide the lever off the shaft.
mechanism.
Insert the locking pieces
(Might be necessary depending
on the bone graft).
Remove the bone material
1. Tap the collecting container
on its base one or two times with
force.
2. Now separate the two parts
and take out the bones.
IFU-6007 Rev03
20.05.2020