3Shape TRIOS 5 - System Safety; Prerequisites for System Use; Potential Mechanical Damages; Explosion Hazards

7
ENGLISH
4.18 Distances Between System and Other Equipment
The TRIOS system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the TRIOS system
can help prevent electromagnetic interference by maintaining a minimum distance
between portable or mobile RF communications equipment (transmitters) andthe
TRIOS system as recommended below, according to the maximum output power ofthe
communicationequipment.
Rated maximum output
power of transmitter, W
Separation distance according to frequency
of transmitter, m
150 kHz
to80 MHz
d = 1,2
P
80 MHz
to800MHz
d = 1,2
P
800 MHz
to2,5 GHz
d = 2,3
P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, therecommended
separation distance d in metres (m) can be estimated using the equation applicable
to the frequency of the trans-mitter, where P isthemaximum output power rating
of the transmitter in watts (W) according tothetransmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
Model L1P-1F
Connection Type Recommended use distances
Scanner – PC Wireless
Distance between TRIOS scanner and wifi dongle/
access point should be between 0.5 and 5m for best
performance.
5. System Safety
5.1 Prerequisites
CAUTION
Read all instructions carefully, including all warnings and caution notices.
You must comply with the warnings in this manual to prevent injury
to persons and damage to equipment. Proper functionality and safety can
only be guaranteed if the safety precautions in this safety guide and on
the TRIOS system are observed.
Preventive inspection before use of the system
WARNING
Please examine the TRIOS system for any mechanical damage on:
• All enclosures.
• All cables.
Safety can only be guaranteed if NO DAMAGE to the TRIOS system is observed.
Modifications of the system
Warning
Do not modify the TRIOS system without authorization the manufacturer.
Approved software only
CAUTION
Install only approved software – to prevent interference with TRIOS system
performance.
Only connect specified items
Warning
Only connect items that have been specified as part of the TRIOS system
or have been specified as being compatible with the TRIOS system.
Training
WARNING
Before you attempt to use the TRIOS system with patients:
• You must have read and understood all sections of this guide describing
correct operation.
• You must be thoroughly familiar with the safe operation of the TRIOS
system as described in this documentation.
• If the instructions for operating the TRIOS system as described in this
guide are NOT observed and followed, the intended function and its
safety for the user and patient may be impaired.
In case of equipment failure
CAUTION
If at any time the TRIOS system malfunctions, or if you suspect in any way
that the TRIOS system is not working correctly:
• Remove the TRIOS scanner contact to patient immediately.
• Unplug the charger and make sure it cannot be used before it is checked.
• Contact your 3Shape support.
• Do not attempt to open any covers on the TRIOS system.
vWireless Connection
The wireless TRIOS scanner is intended to be used indoors, in a domestic or commercial
electromagnetic environment. The wireless connection is intended to relay image stream
data and control data between the TRIOS scanner and the TRIOS software. The communication
between TRIOS Scanner and TRIOS software is handled by 3Shape communication services.
CAUTION
Other portable and mobile RF communication equipment could interfere
with the wireless TRIOS scanner, even if the other equipment complies with
CISPR emission requirements.
CAUTION
The wireless TRIOS scanner could interfere with other portable and mobile
RF communication equipment.
IMPORTANT NOTICE
It is recommended to keep a line of sight between the wireless TRIOS
scanner and the USB wireless dongle attached to the PC.
5.2 Potential Mechanical Damages
Inspect TRIOS scanner tip before using
WARNING
Damaged tip may cause injuries to the patient.
Inspect TRIOS scanner tips before use to ensure
that there is no damage to the TRIOS scanner
tip surfaces.
Dropped or damaged equipment
WARNING
Performance of the scanner tip is compromised
when dropped. If the TRIOS scanner tip is dropped
on the floor, the tip must be disposed of and not
to be used for scanning. (see this guide’s instructions
on 9. Disposal).
WARNING
The performance of the TRIOS scanner may be
compromised when dropped. If the handheld
scanner is dropped or bumped, it must be
checked immediately before further use.
• Unplug the system and make sure it cannot be
used before it is checked.
• Examine the TRIOS system for any mechanical
damage or malfunction.
• If at any time the TRIOS system malfunctions,
or if you suspect in any way that the TRIOS
system is not working correctly contact your
reseller or 3Shape.
• Do not attempt to open any covers on the
TRIOS system.
WARNING
The performance of the battery may be
compromised when dropped, If a battery is
dropped, It must be examined for any mechanical
damage or malfunction. If a mechanical damage
or malfunction is observed or suspected, the
battery must be disposed of (see this guide’s
instructions on 9. Disposal).