ARC InstaTemp MD Manuale utente

Non-Touch Thermometer
User Manual
ARC Devices Ltd.
Copyright ARC Devices Ltd. 2016
PT-100153-IMD Rev 03
®

page 2 of 36
INTRODUCTION
The ARC InstaTemp MD is a sophisticated,
technologically advanced electronic medical
device that has been carefully engineered to
quickly and accurately measure human body
temperature without requiring any contact with
the human body. To ensure the best results with
your ARC InstaTemp MD thermometer, please
be sure to read the following operational and
procedural manual carefully. If you give this
device to another adult, it is vital that you include
this user manual. The ARC InstaTemp MD is an ad-
justed mode clinical thermometer as per ISO 80601-
2-56.
Intended Use
The ARC InstaTemp MD is intended for use by a
Health Care Professional, in a clinical environment,
for the measurement and display of human body
temperature for patients of all ages. This device is
not intended for home use.
The CE Mark of this device refers to the
EC Directive MDD 93/42/EEC.
0123

page 3 of 36
KEY INFORMATION
Recommended use: Operate ARC InstaTemp MD in a
clinical setting with ambient temperatures ranging
from 59-95˚F (15-35˚C).
Always protect the sensor, which is in the recess
at the top of the device (see illustration on page
4) from shocks or contamination. See Precautions
(page 22) and Cleaning (page 25) for more details.
Package Contents
The package contains:
• The ARC InstaTemp MD
• This user manual
• Wall mount (optional accessory, may not be
included)
• Retractable tether (optional accessory, may
not be included)

page 4 of 36
GETTING TO KNOW
The ARC InstaTemp MD
ARC InstaTemp MD
Infrared Sensor
Backlit LCD
Display Screen
(remove protective label prior to
use)
Temperature Range
Indicator Light
Activation Button
Hole for tether/wall mount
Internal, non-replaceable
batteries are included

page 5 of 36
GETTING TO KNOW
The ARC InstaTemp MD
Features
Accurate body temperature measured
from the forehead in 2.5 seconds
LCD screen with backlight for ease of
use in low-light conditions
Temperature shown in either degrees
Fahrenheit (˚F) or degrees Celsius (˚C)
The temperature reading, when
ready, is displayed on backlit LCD
screen for 4 seconds
Turns off automatically when not
in use
Fast temperature readings that meet
the ASTM 1965-98 and IEC80601-2-56
standards
LED display temperature range indi-
cator system: Green, Orange, Red.
Low battery indicator
Test mode for LCD screen check
1
2
3
4
5
6
7
8
9

page 6 of 36
DEVICE SETUP
The ARC InstaTemp MD
Before using the device for the rst time:
REMOVE FROM PACKAGING
READ ALL SECTIONS OF THE IFU.
REMOVE THE PROTECTIVE LABEL FROM
THE LCD SCREEN
SET THE UNITS
The ARC InstaTemp MD can display temperatures
in degrees Fahrenheit or degrees Celsius. Follow
the steps page on 7 to toggle between °F or °C and
select the preferred measurement units for dis-
play.
AFFIX THE WALL MOUNT (optional
accessory)
While not in use, the ARC InstaTemp MD should
be stored using the wall mount. In an operational
environment make sure to secure the wall mount
away from any direct heating, cooling or ventila-
tion systems. Otherwise the ARC InstaTemp MD
should be stored in a manner which protects the
sensor from contamination or damage. [See Car-
rying and Storage, page 20]
ATTACH THE RETRACTING TETHER
(optional accessory)
The retracting tether can be used to safely carry
the ARC InstaTemp MD between uses. [See Carry-
ing and Storage, page 20]
1
4
5
6
2
3

page 7 of 36
OPERATIONS
Changing Between Fahrenheit and Celsius:
The ARC InstaTemp MD is set to Fahrenheit by
default. To change to Celsius, follow these simple
steps:
Press and hold the activation
button to get a reading, which can
be a temperature reading, Lo, Hi
or “---”.
Once the reading appears on
screen in Fahrenheit, press and
release the activation button again
—the reading will automatically
change to Celsius.
Repeat steps 1 and 2 to change
back.
Note: Once the display units are set (°F or
°C), they remain as the default display units
until changed again
1
2
!

page 8 of 36
Prepare the patient.
Move hair if present and all
obstructions away from the path of
the sensor
Wipe perspiration from the forehead,
if apparent
The surface temperature of a human
being is sensitive to extreme hot and
coldtemperaturesandphysicalexertion.
It is important to assess the patient and
allowtimeforthesurfacetemperatureto
equilibrate to its environment
Do not touch the lens of the sensor or
the area surrounding the front of the
device. It is the most delicate part of
the ARC InstaTemp MD
OPERATIONS
Prepare To Take A Reading
1

page 9 of 36
The surface temperature of a human
being is sensitive to extreme hot and
coldtemperaturesandphysicalexertion.
It is important to assess the patient and
allowtimeforthesurfacetemperatureto
equilibrate to its environment.
NON
STERILE
Storage and
transport
temperature
Non Sterile
Do not
expose to
sunlight
Keep away
from heat
1
2
3
Caution
consult
documents
6
Protect from
rain
Keep Dry
4
Not to be
used
in case
package is
damaged
5
Caution
consult
documents
7
Lot Code
See Base of
device
8
LOT

page 10 of 36
Point the thermometer at the patient,
without touching them, as shown above.
Ensure the device is approximately 0.5-1.25”
(between 1 and 3cm) from the forehead,
above the eyebrows and between the eyes.
Thermometer must be held steady,
perpendicular to and pointing directly at
the center of the forehead at the area above
the eyebrows and between the eyes when
taking a temperature.
OPERATIONS
Taking A Temperature
2
A
NON
STERILE
Storage and
transport
temperature
Non Sterile
Do not
expose to
sunlight
Keep away
from heat
1
2
3
Caution
consult
documents
6
Protect from
rain
Keep Dry
4
Not to be
used
in case
package is
damaged
5
Caution
consult
documents
7
Lot Code
See Base of
device
8
LOT
Hold for
2.5 seconds
0.5” - 1.25”
(1-3cm)
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1
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