ARC InstaTemp MD User manual

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)

page 11 of 36
Hold the thermometer in position. Press and
hold the activation button until the display
is illuminated and a temperature reading
is displayed on the screen. This will take
approximately 2.5 seconds.
The activation button should be released
when the display back light turns on and the
result is displayed on the screen.
Keep the device as steady as possible
during the measurement process. The LCD
backlight is off and displays “188.8” during
the measurement process. The backlight of
the LCD comes on when the measurement
process is complete.
OPERATIONS
B
™
™
™
™
Hold for
2.5 seconds
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 12 of 36
The temperature will be displayed for 4 seconds on
the display screen. The LCD display will show a tem-
perature in ˚F or ˚C.
The temperature
range indicator will
be green, orange or
red, depending on
how high or low the
temperature is from
normal. [See the
Operations section on
page 13 for a detailed
explanation of the
temperature ranges.]
Should you wish to take a second reading, wait for
the LCD display to turn off rst. Wait 15 seconds
between measurements.
Holding the device in your hand for prolonged
periods of time may affect the readings. It is not
recommended to hold the device in your hand
between measurements.
OPERATIONS
Reading the Temperature Indicator
3
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
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 13 of 36
The temperature range indicator will display
one of three colors: green, orange, or red.
The temperature range indicator
colors indicate the degree to which the
patient’s temperature is outside the
“normal” range.
Green: Temperatures within
normal range. See tables (pages
14 & 15)
Orange: Temperature is mildly
outside of normal range
(whether hot or cold)
See tables (pages 14 & 15)
Red: Temperature is excessively
outside of normal range
(whether hot or cold)
See tables (pages 14 & 15)
OPERATIONS
Understanding the Temperature Range Indicator Color
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 14 of 36
OPERATIONS
Understanding The Temperature Range
>109.1°F
≥100.5⁰F - ≤109.1⁰F
≥99.0⁰F - <100.5⁰F
≥96.7⁰F - <99.0⁰F
≥94.9⁰F - <96.7⁰F
≥89.5⁰F - <94.9⁰F
<89.5⁰F
HI
Temp in ˚F
Temp in ˚F
Temp in ˚F
Temp in ˚F
Temp in ˚F
LO
Indicator Light
Temperature Range
FAHRENHEIT (˚F)
Display Readout
Note: a red indicator light may mean “very
hot” or “very cold”.
Outside the measurable range, 89.5˚ - 109.1°F,
the screen shows “HI” or “LO” as applicable.
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
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 15 of 36
OPERATIONS
Understanding The Temperature Range
HI
Temp in ˚C
Temp in ˚C
Temp in ˚C
Temp in ˚C
Temp in ˚C
LO
Indicator Light
CELSIUS (˚C)
Temperature Range
Display Readout Display Readout
>42.8°C
≥38.0⁰C - ≤42.8⁰C
≥37.2⁰C - <38.0⁰C
≥36.0⁰C - <37.2⁰C
≥35.0⁰C - <36.0⁰C
≥32.0⁰C - <35.0⁰C
<32°C
Note: a red indicator light may mean “very
hot” or “very cold”.
Outside the measurable range, 32˚ - 42.8˚°C,
the screen shows “HI” or “LO” as applicable.
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
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 16 of 36
OPERATIONS
Temperature Range “HI” & “LO”
A “HI” Reading
The LCD will display ‘HI’. This
indicates that the temperature
which the thermometer has
measured is outside the
device’s measurement range
(i.e. >109.1°F/ >42.8°C).
A “LO” Reading
The LCD will display ‘LO’. This
indicates that the temperature
which the thermometer has
measured is outside the
device’s measurement range
(i.e. <89.5° F/ <32° C).
Above 109.1º F / 42.8˚ C
Below 89.5º F / 32˚ C

page 17 of 36
OPERATIONS
Other Screen Indications
After 4 seconds the
backlight, LCD display and
temperature range indicator
turn off and the thermome-
ter powers down.
If the display remains
in this state after the
button is pressed then
the battery is no longer
working.
An Error message indicates
an internal problem with
the thermometer
(see pg. 28 for error codes).
If an Error message
is displayed, please
contact ARC Devices or
your distributor.
Indication Meaning
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
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
Contact info on page 36 of this document.

page 18 of 36
This indicates an invalid
reading. This is due to incorrect
usage, such as:
• trying to measure a tempera-
ture when the ambient tempera-
ture is outside the operating
temperature range.
• an indeterminate reading
because the activation button
was not held until the display
was illuminated.
• temperature measurement
failed due to too much
movement by the operator or
patient. Wait 15 seconds and
repeat the temperature.
Repeat the temperature
measurement as described in
the section titled “Taking the
Temperature.” (page 10)
Indication Meaning
OPERATIONS
Other Screen Indications

page 19 of 36
Flashing battery symbol will
start being displayed when
there is battery power for
approx. 500 measurements left.
Refer to page 34,
warranty information.
Steady battery symbol & red
indicator light: insucient
battery power for a
measurement. Replace your ARC
InstaTemp MD
Refer to page 34,
warranty information.
Indication Meaning
OPERATIONS
Other Screen Indications
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
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 20 of 36
The wall mount (if included) is provided to
help protect the sensor in its recess position by
mounting the ARC InstaTemp MD on the wall
mount with the sensor facing toward the oor.
The retractable tether (if included) is provided
as means of carrying the ARC InstaTemp MD and
keeping the device at ambient temperature.
Note: You should choose to use either the
wall mount or the retractable tether, as
they do not work together. Do not place
the wall mount in any location with direct
cooling or ventilation.
Wall Mount
The wall mount can be attached to any smooth
vertical surface using its adhesive pad on the
rear of the wall mount. Because it is magnetic,
the wall mount can also be attached to any
metal surface. The internal magnet also keeps
the ARC InstaTemp MD gently attached to the
wall mount.
CARRYING & STORAGE
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