Infoscan MED Recorder
Patient Manual
Indications for Use
The Infoscan MED Recorder is indicated for use by Health Care Professional (HCP), where it may
aid in the diagnosis of sleep disordered breathing for adult patients. The Infoscan MED Recorder
records the following data: patient respiratory airflow, snoring, blood oxygen saturation, pulse and
body position during sleep. The device uses these recordings to produce a report for the HCP that
may aid in the diagnosis of sleep disordered breathing for further clinical evaluation. The device is
intended for home and hospital use under the direction of a HCP.
Device Description
The Infoscan MED Recorder is a medical device used in the diagnostic evaluation of adults
suspected of having sleep apnea.
Warnings and Cautions
•
MED Recorder is an at home use prescription device. Federal restricts the use of this device to
sale or use by physician, or as predicated by physician. MED Recorder uses built-in rechargeable
battery.
•
Patients with artificial pacemakers or internal cardiac defibrillators (ICD) MUST NOT use the
device.
•
Device MUST NOT be used while the battery is being charged.
•
Device MUST NOT be used during bath or shower.
•
MED Recorder Device uses an internal date and timer. Precision of the date and time depends
on the accurate setting of the internal clock.
•
The usage of accessories, sensors or cables other than those provided by Infoscan may have a
negative impact on device performance and may a
ff
ect measurement accuracy.
•
MED Recorder Device should not work at less than 3 feet from other electronical devices that
generate electromagnetic fields, due to the possibility of interference.
•
Device should be used only during the recording to avoid skin irritation from prolonged contact
with the accessories.
•
Device should be kept and used away from particulate and do not expose it to intense sunlight.
•
Device should be protected from exposure to high humidity (such as rain), which may cause
damage or a
ff
ect its performance.
•
DO NOT use the device, sensors, leads or cables that appear damaged or are defective.
•
Protect the device from damage caused by unintentional drop, collision, strong vibration or
other mechanical force during servicing.
•
Use the supplied belt and do not lift the device by its sensor or cables to avoid disconnection.
•
Store and use the device away from pets, pests and children, their action can cause damage to
the device or accessories.
•
Changes or modifications not expressly approved by Infoscan S.A. could void the user’s
authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
Battery Information
Your MED Recorder has a built-in rechargeable battery and will be fully charged when you receive
it.
Device MUST NOT be used while battery is being charged.
Troubleshooting
If Nonin pulse Oximeter does not detect a finger it is necessary to ensure that the sensor is connected
properly to socket. If “Data Unavailable” message is still displayed check whether the sensor is shining.
If you see red light and none of your fingers can catch measurement contact with Infoscan service.
If body position and airflow sensors do not record data is necessary to ensure that they are connected
properly to socket. If they are but no movement or airflow data are registered contact with Infoscan
service.
If you notice that one of the pieces of medical tape is coming o
ff
secure it with additional medical
tape.
Range and Accuracy of Measurements
Pulse Oximetry
•
SpO2: 0 to 100%
•
Pulse rate range: 18 to 321 beats per minute
•
SpO2 accuracy (70-100%) +/- 2 digits
•
Pulse rate accuracy (18-300 BPM): +/- 3 digits
Airflow
•
Data sampling rate: 45 times/second, qualitative measurement determining airflow in di
ff
erent
passage of the respiratory system
Body movement (accelerometers)
•
Data sampling rate: 45 times/second, qualitative measurement
Technical Parameters
•
Operating temperature: 5°C to 40°C (41°F to 104°F)
•
Temperature of storage: -25°C to 70°C (-13°F to 158°F)
•
Humidity: 15% to 90% non-condensing
•
Maximum altitude: 2000m a.s.l
•
Power requirements: 170mW (screen o
ff
), 350mW (screen on)
•
Power supply: Internal battery Li-Polymer, constant voltage 3.6-4.2V
•
Dimensions (without sensors): 120 mm (depth)
×
75 mm (width)
×
32 mm (height ) (4.72”
×
2.95”
×
1.26”)
•
Weight: 135 g (with battery)
•
Accuracy of internal timer < ±1 s/day
•
Blood saturation sensor specifications: in accordance with NONIN® PureLight® series 8000
•
Airflow and body movement sensors: provided only by Infoscan
•
Fully charged battery life is su
ffi
cient for up to 24 hours continuous operation
•
Life of battery: up to 12 months
•
Technical inspection recommended: every 12 months
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to radio
or television reception, which can be determined by turning the equipment o and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
•
Reorient or relocate the receiving antenna.
•
Increase the separation between the equipment and receiver.
•
Connect the equipment into an outlet on a circuit di
ff
erent from that to which the receiver is
connected.
•
Consult the dealer or an experienced radio/TV technician for help
Producer:
Infoscan S
.A.
17 Rejtana St. apt.16
02-516 Warsaw
phone +48 22 188 18 63
e-mail: info@in
foscan.pl
V1.0 December 2016
