Certification And State Registration - Nissei DS-1011 Instruction Manual

electronic device is forbidden. If needed, repair the device only in specialized organizations.
10 On the expiry of the specifi ed operation term, refer to specialists (specialized repair organizations)
on a periodic basis to check the technical condition of the device.
11 When utilizing the waste, refer to current rules applicable in your region. No special utilization
conditions are specifi ed by the manufacturer for this device
12 Keep the device clean. Inspect its cleanliness after use. To clean, use only a soft dry cloth. Do not
use gasoline, paint thinner, or other strong solvents. The cuff is resistant to repeated sanitation.
The cuff internal fabric surface (being in contact with a patient' arm) can be treated with a cotton
swab moistened in a 3% solution of hydrogen peroxide. Partial discoloration of the cuff covering
tissue is possible if used for a long time. Do not wash the cuff and do not treat it with a hot iron.
13 Do not leave unattended the device plugged into the network.
14 Stop using the device immediately and contact your dealer or the manufacturer in case any visible
damage is found on the device.
15 To avoid any possibility of accidental strangulation, keep this device away from children and do
not drape AIR HOSE around your neck.
16 Do not press the display or place the device with display face down.
17 The device contains small parts and batteries which could be swallowed by children or pets. They
should therefore be kept out of the reach of children and pets at all times.
18 This device is not designed for self-use by unspecifi ed persons in public areas.
19 Any serious incident occurred in relation to the device should be reported to the manufacturer and
the competent authority in your country/area. If you have no contact information of such authority,
please contact the manufacturer or EU authorized representative whose contact information is
indicated in this instruction manual.

CERTIFICATION AND STATE REGISTRATION

The production of devices is certifi ed pursuant to international standards ISO 9001, ISO 13485, ISO 14001.
The device meets international standards IEC 60601-1:2005+A1:2012 and IEC 60601-1-2:2014.
AC Adaptor ADP-W5 meets international standard IEC60601-1 by JQA, class II.
Produced by Nihon Seimitsu Sokki Co., Ltd.
Address: 2508-13 Nakago Shibukawa Gunma 377-0293 Japan
website: www.nissei.pl
EC-Representative: MDSS GmbH Schiff graben 41, 30175 Hannover, Germany
TECHNICAL DESCRIPTION FOR ELECTROMAGNETIC DISTURBANCES
The device complies with the Electromagnetic Disturbances standard, IEC60601-1-2:2014.
As a medical electrical equipment, special precautions regarding the electromagnetic disturbances shall
be taken at usage of the device according to the information provided below.
• The device is not intended for use in environments where the intensity of electromagnetic disturbance
is high, such as near active HF surgical equipment and MRI (magnetic resonance imaging) equipment etc.
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