User Manual
41
Note
*Note
！
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 off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
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 the receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
CAUTION:
To assure continued FCC compliance:
1. Any changes or modifications not expressly approved by the grantee of this device could void the user's
authority to operate the equipment.
2. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This
equipment should be installed and operated with minimum distance 20cm between the radiator & your body.
FCC Label Compliance Statement:
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.
*Note
！
“Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate
the equipment”.
HL858CG essential performance per IEC 80601-2-30 additional essential
performance requirements:
201.12.1.102 Limits of the error of the manometer from
environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104 °F ) and
the relative humidity range of 15 % to 93 %(non-condensing), the
maximum error for the measurement of the CUFF pressure at any
point of the NOMINAL measurement range shall be less than or equal
to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading, whichever is greater.
201.12.1.107 Limits of the change in error of the blood pressure
determination
The laboratory limits of the change in error of the BLOOD PRESSURE
DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be
less than 3 mmHg (0.4 kPa).
HL858CG essential performance per IEC 80601-2-30 additional essential
performance requirements:
201.12.1.102 Limits of the error of the manometer from
environmental conditions
Over the temperature range of 5 °C to 40 °C (41 °F ~ 104 °F ) and
the relative humidity range of 15 % to 93 %(non-condensing), the
maximum error for the measurement of the CUFF pressure at any
point of the NOMINAL measurement range shall be less than or equal
to ± 3 mmHg (± 0.4 kPa) or 2 % of the reading, whichever is greater.
201.12.1.107 Limits of the change in error of the blood pressure
determination
The laboratory limits of the change in error of the BLOOD PRESSURE
DETERMINATION of the AUTOMATED SPHYGMOMANOMETER shall be
less than 3 mmHg (0.4 kPa).
Essential Performance compliance criteria:
HL858CB essential performance compliance criteria of IEC 60601-1-2
forimmunity testing:
The following degradations that associated with basic safety and
essentialperformance should not be allowed.
- Component failure;
-Change in programmable parameters;
-Reset to factory default and the unintended default would interfere
withdiagnosis, treatment, or monitoring;
False alarm;
-Initiation of any unintended operation, including unintended
oruncontrolled motion, even if accompanied by an alarm;
-Error of a display numerical value sufficiently large to affect diagnosisor
treatment or monitoring.
-Noise on a waveform in which the noise would interfere with diagnosis
ortreatment or monitoring.
CAUTION:
THE GRANTEE IS NOT RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS NOT
EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH
MODIFICATIONS COULD VOID THE USER'S AUTHORITY TO OPERATE THE EQUIPMENT.