module
Si-SQ
Instructions for Use
Edition USA
2
Contents
Symbols ...................................................................................................................................................................................................... 3 – 5
1. Introduction .........................................................................................................................................................................................6 – 7
2. Electromagnetic compatibility (EMC) ....................................................................................................................................................8
3. Equipment supplied ..................................................................................................................................................................................9
4. Safety notes ................................................................................................................................................................................... 10 – 11
5. Description ..............................................................................................................................................................................................12
6. Start-up – General ...................................................................................................................................................................................13
7. Operation ....................................................................................................................................................................................... 14 – 16
8. Operation documentation .............................................................................................................................................................. 17 – 18
9. Hygiene and maintenance ............................................................................................................................................................ 19 – 23
10. W&H accessories and spare parts ........................................................................................................................................................24
11. Servicing ......................................................................................................................................................................................... 25 – 26
12. Technical data ................................................................................................................................................................................27 – 28
13. Disposal ...................................................................................................................................................................................................29
Explanation of warranty terms .......................................................................................................................................................................31
Authorized W&H service partners ..................................................................................................................................................................32
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
Call customer serviceSterilizable
up to the stated temperature
4
Symbols on the Osstell ISQ module
Date of manufacture
Article number
Serial number
Direct current
Supply voltage
of the control unit
Type B applied part (not suitable
for intracardiac application)
Do not dispose of with
domestic waste
Consult Instructions for Use
The medical device with reference to electrical safety, mechanical safety
and fire prevention conforms to UL 60601-1:2006,
CAN/CSA-C22.2 No.601.1-M90:2005, CAN/CSA-C22.2 No. 60601-1:2008,
ANSI/AAMI ES 60601-1:2005 25UX (Control No.)
DC
V
Data Matrix code
for product information
including UDI (Unique Device
Identification)
CE mark
with identification number
of the Notified Body
XXXX
5
Symbols on the packaging
This way up
Caution! Federal law restricts this device to sale
by or on the order of a dentist, physician or any
other practitioner licensed by the law of the state
in which he or she practices to use or order the use
of the device.
Fragile, handle with care
Keep dry
Permitted temperature range
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 mark
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)
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.
It is therefore essential that you observe the safety notes on page 10 – 11.
Intended use
Osstell ISQ module is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. Osstell
ISQ module 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
The Osstell ISQ module is intended for use by suitably qualified and trained medical, technical and specialist staff only.
We have based our development and design of the Osstell ISQ module on the "physician" target group.
7
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 32).
> Unauthorized opening of the equipment invalidates all claims under warranty and any other claims.
8
2. Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to particular precautions with regards 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 Directives only when used with original W&H accessories and
spare parts. The use of accessories and spare parts that have not been approved by W&H may lead to increased emission
of electromagnetic interference or to reduced resistance to electromagnetic interference.
You can find the current EMC manufacturer’s declaration on our website at http://wh.com
or, alternatively, you can also request a copy directly from the manufacturer.
HF communication equipment
Do not use any portable and mobile HF communication equipment (e.g., mobile telephones) during operation.
These may affect medical electrical equipment.
9
3. Scope of delivery
REF Description
30210000 Osstell ISQ module
07849900 TestPeg
077218 0 0 Universal support
07460300 SmartPeg mount
10
4. Safety notes – general
> 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.
Hygiene and maintenance before using for the first time
> Sterilize the measuring probe with cable.
Improper use
In addition to unauthorized assembly, installation, modification of or repairs to the Osstell ISQ module and measuring probe
with cable, dental handpieces and non-compliance with our instructions, improper use will invalidate all claims made under
warranty
or otherwise.
The Osstell ISQ module is classed as “conventional equipment” (closed equipment without protection against the ingress
of water).
11
Safety notes – general
Danger zones M and G
The Osstell ISQ module with the measuring probe is not suitable for use in potentially explosive atmospheres or with
potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide according to IEC 60601-1/ANSI/
AAMI ES 60601-1.
The Osstell ISQ module with the measuring probe is not suitable for use in oxygen-enriched atmospheres.
Zone M, also referred to as the “medical environment”, includes the part of a room in which potentially explosive
atmospheres may occur as a result of the use of analgesics or medical skin cleaning or disinfectants, but only
in small quantities and only for a short time.
Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle.
Zone G, also referred to as an “enclosed medical gas system”, comprises not necessarily fully enclosed cavities in
which permanent or temporary potentially explosive mixtures may be generated, supplied or used in small quantities.
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