Use Instructions

HemoPill
®
ACUTE
Instructions for use U.S.A.
Ref. № 500.01
Capsule dimensions:
Length 26.3 mm
Maximum diameter Ø 7.0 mm
PRODUCT DESCRIPTION
The HemoPill acute is an active diagnostic medical device. The capsule is battery operated and
features a housing with a measuring gap containing an optical sensor. The signals of the
HemoPill acute sensor correlate with the presence of blood in the measuring gap of the capsule
and are transmitted wirelessly to the HemoPill Receiver.
The HemoPill acute is able to detect liquid blood (or hematin) in quantities of ≥ 20 ml with a
sensitivity and specificity of > 80%*.
The HemoPill acute is designed only for use with the HemoPill Receiver (ref. no. 500.20,
Ovesco Endoscopy AG).
*Data is based on scientific analysis confirmed by a clinical study (DING study).
INDICATION
The HemoPill acute is used for diagnosis in patients with suspected acute bleeding in the
esophagus, stomach, and small intestine. The HemoPill acute is intended for use in adults and
young patients aged 14 years and above. There is no clinical data concerning use on patients
aged between 14 and 18. The HemoPill acute is administered by swallowing.
CONTRAINDICATION
Use of the HemoPill acute is contraindicated in the following conditions:
• known gastrointestinal obstruction, stricture, fistula, or diverticula
• dysphagia or other swallowing disorders
• during pregnancy
• impaired consciousness that prevents autonomous swallowing of the capsule
• in patients with cardiac pacemakers and other implanted electromedical devices
COMPLICATIONS
The following complications are possible when the HemoPill acute system is used as intended:
• aspiration of the capsule on ingestion
• delayed excretion, or failure to excrete the capsule (capsule retention)
• obstruction of the digestive tract
• injury to tissue structures during the passage of the HemoPill acute through the digestive
tract. In particular, this may involve:
− injury to the mucosa
− bleeding, e. g. variceal bleeding
− perforations
GENERAL INFORMATION
Using these instructions for use
Carefully read these instructions for use and the instructions for the HemoPill
Receiver
before using the HemoPill
acute. The user should have fully understood how the product works
and how it should be handled.
The user must ensure that the HemoPill
acute system is used and the measured values are
interpreted in accordance with the instructions for use.
Using this product
The product must be used only for its intended purpose. Even if the product is used as
intended, side effect
s may occur. For this reason, Ovesco products should only be used by
persons who are qualified and trained to use the specific products for their intended purpose.
The HemoPill
acute can be used by doctors, nursing staff or medical staff with equivalent
training.
BEFORE USE
1. Switching on the HemoPill Receiver
Switch on the HemoPill Receiver and select the "Connect" menu (see instructions for use for
the HemoPill Receiver).
2. Activating the HemoPill acute
The HemoPill acute must be activated before it is removed from the blister packaging. The
capsule is activated by light in the activation area of the capsule (1). Use the LED light source
integrated in the HemoPill Receiver (2).
Switch on the LED via the display on the HemoPill Receiver and press the "LED" button in the
"Connect" menu. The LED will light up for approx. 5 seconds after you have pressed the button.
Figure 1
Place the blister packaging against the left side of the HemoPill Receiver and align the grey
triangle markings on the blister and the HemoPill Receiver to each other.
Hold the blister immediately next to the LED of the Receiver (fig. 2). If necessary, move the
blister slightly around the LED of the Receiver.
Figure 2
When the capsule is activated, the light source of the capsule flashes at regular intervals. Note
the color of the flashing signal (fig. 3):
Flashing blue:
HemoPill acute is ready for use.
Flashing red:
HemoPill acute is defective and must not
be used.
Figure 3
3. Establishing a data connection
Comparing the capsule ID
When establishing a data connection, it is important to ensure that the capsule ID shown
on the HemoPill
Receiver matches the capsule ID on the blister packaging. Connecting to an
incorrect HemoPill acute can lead to false negative results.
The capsule ID is indicated directly on the
blister packaging.
The separately enclosed patient labels (four
stickers) serve the documentation in the patient
file.
Figure 4