Osstell ISQ Si-SQ Instruction Manual
Instructions for Use
Edition USA
module
Si-SQ
Contents
Symbols .......................................................................................................................................................................................................... 3
1. Introduction .............................................................................................................................................................................................. 6
2. Electromagnetic compatibility (EMC) ..................................................................................................................................................... 8
3. Scope of delivery ...................................................................................................................................................................................... 9
4. Safety notes ............................................................................................................................................................................................ 10
5. Description............................................................................................................................................................................................... 11
6. Start-up .....................................................................................................................................................................................................12
7. Operation ...................................................................................................................................................................................................13
8. Hygiene and maintenance ...................................................................................................................................................................... 16
9. Servicing .................................................................................................................................................................................................. 27
10. W&H accessories and spare parts ....................................................................................................................................................... 29
11. Technical data ....................................................................................................................................................................................... 30
12. Disposal ................................................................................................................................................................................................. 32
Explanation of warranty terms ................................................................................................................................................................... 34
Authorized W&H service partners .............................................................................................................................................................. 35
Manufacturer’s declaration.........................................................................................................................................................................36
2
Symbols
in the Instructions for Use
WARNING!
(if persons could be injured)
up to the stated temperature
ATTENTION!
(if property could be damaged)
Call customer serviceSterilizable
General explanations,
without risk to persons or property
3
Symbols
on the Osstell ISQ module
Follow Instructions for Use
Date of manufacture
Do not dispose of with
domestic waste
XXXX
Type B applied part (not suitable
for intracardiac application)
CE mark
with identification number
of the Notified Body
Data Matrix code
for product information
including UDI (Unique Device
Identification)
Catalogue number
Serial number
DC – direct current
4
Symbols
on the packaging
XXXX
CE mark
with identification number
of the Notified Body
This way up
Fragile, handle with care
Keep dry
»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.
8 %
80 %
Data Matrix code
for product information
Identification)
Device
including UDI (Unique
Data structure in accordance with
Health Industry Bar Code
+70 °C (+158°F) Max.
Permitted temperature range
Humidity,
Limitation
Caution! According to Federal law, this medical
device may only be sold by or on the order of a
dentist, physician or any other medical practitioner
licensed by the law of the State in which he or she
practices and intends to use or order the use of this
medical device.
5
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 Osstell ISQ module 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 Osstell unit for Implantmed on the “physician” target group.
6
Introduction
Production according to EU Directive
The medical device complies with the regulations of Directive 93/42/EEC.
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. Assembly, modifications or repairs
must only be undertaken by an authorized W&H service partner (see page 35).
> Unauthorized opening of the equipment 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.
7
2. Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into
operation in accordance with the EMC notes included.
W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories
and spare parts. The use of accessories and spare parts not approved by W&H can lead to an increased emission of
electromagnetic interference or to a reduced resistance against electromagnetic interference.
HF communication equipment
Portable HF communications equipment (including peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical
device could result.
The medical device may be interfered by other equipment, even if these other devices comply with CISPR (International
special committee on radio interference) emission requirements.
Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this medical device and the other equipment should be observed to verify that
they are operating normally.
The medical device is not intended for use in the vicinity of HF surgical devices.
8
3. Scope of delivery
REF Description
30210000 Osstell ISQ module
07849900 TestPeg
077218 00 Universal support
07460300 SmartPeg mount
9
4. Safety notes
> Before using the Osstell ISQ module for the first time, store it at room temperature for 24 hours.
> Check the Osstell ISQ module and the measuring probe with cable for damage and loose parts every time before use.
> Do not operate the Osstell ISQ module and the measuring probe with cable 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 Osstell ISQ module is not approved for operation in potentially explosive atmospheres.
Do not twist or kink the cable! Do not coil it too tightly!
The Osstell ISQ module 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.
General
10
5. Description
SmartPeg mount
TestPeg
USB cable
Osstell ISQ module
Measuring probe connection
Measuring probe with cable
11
6. Start-up
General
Push in the Osstell ISQ
module until it locks audibly.
Pay attention to
the positioning
of the USB cable!
Connect USB.
Connect measuring probe.
Pay attention to
the positioning!
12
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