Use Instructions

Ovesco Endoscopy AG | Friedrich-Miescher-Str. 9 | 72076 Tuebingen | Germany | Telephone [phone] | Fax [phone] | www.ovesco.com | [e-mail]
OVE_HemoPill acute_IFU eng-US_Rev.14_DRAFT_2021-03-23_final.docx;2021-03-24
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EXPLANATION OF THE SYMBOLS ON THE PACKAGING
FCC ID:
2AYFH
-OVE-HP
CE mark and identification number of the notified body
Follow the instructions for use
Batch number
Capsule ID
Reference number or ordering number
During operation of the device, electrical energy is applied, which
generates electromagnetic radiation.
Manufacturer
YYYY
-MM-DD
Date of manufacture: year
-month-day
YYYY
-MM-DD
Use by: year
-month-day
EO (ethylene oxide) sterilized
Attention! Only to be used by trained
personnel
Not suitable for re
-use
Do not re
-sterilize
Do not use if packaging is damaged
Protect against heat (solar radiation)
Temperature limitation
Number of items per package
Applied part type BF
MR
Conditional
Latex
-free
TECHNICAL DATA
Battery type
Silver oxide
Dimensions
26.3 mm x 7.0 mm
Weight
Approx. 2 g
Wireless specification
Operating frequency range
433.05 MHz to 434.79 MHz
Send frequency
434.42 MHz
Send bandwidth
100 kHz
Send rate
HP acute software version ≥ 2.03.00-01: 0.083 Hz
Modulation
GFSK
ERP
-24 dBm
Environmental conditions for operation, transport and storage
Operation
Storage
Transport
Temperature
+20°C to +40°C
+10°C to +30°C
-10°C to +50°C
Relative humidity
20% to 90% RH; non-condensing
20% to 85% RH; non-condensing
20% to 90% RH; non-condensing
Air pressure
785 to 1,060 hPa
700 to 1,060 hPa
700 to 1,060 hPa
Max. operating height
≤ 2000 m
-
-
EMC INFORMATION
Ensure that no electronic devices that may be affected by electromagnetic fields are located in the vicinity of the HemoPill acute. Any electromagnetic interference can lead to malfunctions and/or
failure of the corresponding device and may therefore endanger users or patients.
Medical electrical devices are subject to specific precautionary measures relating to EMC and must be installed and commissioned in accordance with the EMC instructions contained in the
accompanying documentation.
Guidelines and manufacturer's declaration: Electromagnetic immunity
The HemoPill acute is intended for use in an electromagnetic environment as specified below. The user must ensure that the device is operated in such an environment.
Measurement of emitted interference
Conformity
HF emissions acc. to CISPR11
Group 1
HF emissions acc. to CISPR11
Class B
Guidelines and manufacturer declaration: Electromagnetic resistance
The HemoPill acute is intended for use in an electromagnetic environment as specified below. The user must ensure that the device is operated in such an environment.
Immunity test
IEC 60601-1-2:2014 test level
Compliance level
Electrostatic discharge (ESD) according to IEC 61000-4-2
± 2, 4, 8 and 15 kV air discharge
± 2, 4 and 8 kV air discharge
Magnetic field at the supply frequency (50/60 Hz) acc. to IEC 61000-4-8
30 A/m
30 A/m
HF radiated disturbances according to IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
a)
80% AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
a)
Test specifications for interference resistance of the housing to wireless telecommunication devices
Test frequency
(MHz)
Band (MHz) Use Modulation Maximum power (W) Distance (m)
Immunity test
level (V/m)
385 380–390 TETRA 400
Pulse modulation
18 Hz
1.8 0.3 27
450 430–470 GMRS 460, FRS 460
FM
± 5 kHz deviation
1 kHz sine wave
2 0.3 28
710
704–787 LTE band 13, 17
Pulse modulation
217 Hz
0.2 0.3 9
745
780
810
800–960
GSM 800/900, TETRA 800, iDEN 820, CDMA
850, LTE band 5
Pulse modulation
18 Hz
2 0.3 28
870
930
1,720
1,700–1,990
GSM 1800; CDMA 1900; GSM 1900; DECT; LTE
band 1, 3, 4, 25; UMTS
Pulse modulation
217 Hz
2 0.3 28
1,845
1,970
2,450 2,400–2,570
Bluetooth, WIFI, 802.11 b/g/n, RFID 2450, LTE
band 7
Pulse modulation
217 Hz
2 0.3 28
5,240
5,100–5,800 WIFI 802.11 a/n
Pulse modulation
217 Hz
0.2 0.3 9
5,500
5,785