W&H Osstell ISQ Manuel utilisateur
Instructions for Use
module
SI-SQ
2
Contents
Symbols.......................................................................................................................................................................................................... 3
1. Introduction ............................................................................................................................................................................................... 6
2. Scope of delivery....................................................................................................................................................................................... 8
3. Safety notes .............................................................................................................................................................................................. 9
4. Description............................................................................................................................................................................................... 10
5. Start-up .................................................................................................................................................................................................... 11
6. Operation...................................................................................................................................................................................................12
7. Hygiene and maintenance ...................................................................................................................................................................... 15
8. Servicing .................................................................................................................................................................................................. 26
9. W&H accessories and spare parts......................................................................................................................................................... 28
10. Technical data........................................................................................................................................................................................ 29
11. Data on electromagnetic compatibility according to IEC/EN 60601-1-2.......................................................................................... 31
12. Disposal ................................................................................................................................................................................................. 35
Explanation of warranty terms................................................................................................................................................................... 36
Authorized W&H service partners.............................................................................................................................................................. 37
3
Symbols in the Instructions for Use
WARNING!
(if persons could be injured)
ATTENTION!
(if property could be damaged)
General explanations,
without risk to persons or property
Type B applied part (not suitable for
intracardiac application)
Sterilizable
up to the stated temperature
Thermo washer disinfectable
4
Symbols on the Osstell ISQ module
Date of manufacture
Catalogue number
Serial number
DC – direct currentData Matrix code
for product information
including UDI (Unique Device
Identification)
Do not dispose of with
domestic waste
Follow Instructions for Use CE marking
with identification number
of the Notified Body
XXXX
Manufacture Medical Device
5
Symbols on the packaging
This way up
Caution! Federal law restricts this device to sale by or on the order of a
physician, dentist, veterinarian or with the descriptive designation of any
other practitioner licensed by the law of the State in which the practitioner
practices to use or order the use of the device.
Fragile, handle with care
Keep dry Temperature limitation
Humidity limitation
“Der Grüne Punkt” (The Green
Dot) trademark of Duales
System Deutschland GmbH
Trademark of RESY OfW GmbH
for identification of recyclable
transport and outer packaging
of paper and cardboard
-40 °C (-40°F) Min.
+70 °C (+158°F) Max.
8 %
80 %
CE marking
with identification number
of the Notified Body
XXXX
Data structure in
accordance with Health
Industry Bar Code
Data Matrix code
for product information
including UDI (Unique
Device Identification)
Consult Instructions for Use Manufacturer
Catalogue number
Serial number
Date of manufacture
Medical Device
UL Component Recognition
Mark indicates compliance
with Canadian and U.S.
requirements
6
1. Introduction
For your safety and the safety of your patients
These Instructions for Use explain how to use your product. However, we must also warn against possible hazardous situations.
Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us.
Observe the safety notes.
Intended use
Osstell ISQ is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.
Osstell ISQ can add important information to the evaluation of implant stability and can be used as part of an overall treatment
evaluation program. The final implant treatment decisions are the responsibility of the user.
Misuse may damage the medical device and hence cause risks and hazards for patients, users and third parties.
Qualifications of the user
We have based our development and design of the medical device on the »physician« target group.
7
Introduction
Responsibility of the manufacturer
The manufacturer can only accept responsibility for the safety, reliability and performance of the Osstell ISQ module
when compliance with the following instructions is ensured:
> The Osstell ISQ module must be used in accordance with these Instructions for Use.
> The Osstell ISQ module has no components that can be repaired by the user.
> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 37).
> Unauthorized opening of the unit invalidates all claims under warranty and any other claims.
In addition to unauthorized assembly, installation, modification of or repairs to the Osstell ISQ module and measuring probe
with cable, transmission instrument and non-compliance with our instructions, improper use will invalidate all claims made under
warranty or otherwise.
Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the
competent authority!
8
2. Scope of delivery
Osstell ISQ module 30210000
07849900 TestPeg x
07721800 Universal support x
07460300 SmartPeg mount x
07721100 Measuring probe with cable x
9
3. Safety notes General
> Before using the medical device for the first time, store it at room temperature for 24 hours
> Check the medical device for damage and loose parts every time before use.
> Do not operate the medical device if it is damaged.
> Perform a test measurement with the TestPeg prior to every use.
> The responsibility for the use and timely shutdown of the system lies with the user.
> Ensure that it is possible to complete the operation safely should the units or instruments fail.
> The medical device is not approved for operation in potentially explosive atmospheres.
Do not twist or kink the cable! Do not coil it too tightly!
The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress
of water).
Hygiene and maintenance prior to initial use
> Clean and disinfect the Osstell ISQ module and the measuring probe with cable.
> Sterilize the measuring probe with cable.
10
4. Description
TestPeg
Osstell ISQ module
Measuring probe connection
USB cable Measuring probe with cable
SmartPeg mount
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