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Seca 651 User manual

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60 • seca 651/650
17-10-07-653-100_01-2020B
1. About this document . . . . . . . . . . . . . . . . . . . . . . . 62
1.1 Display conventions . . . . . . . . . . . . . . . . . . . . . 62
Display in the text . . . . . . . . . . . . . . . . . . . . . 62
Display in graphics . . . . . . . . . . . . . . . . . . . . 62
1.2 PDF version . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
2. Description of device . . . . . . . . . . . . . . . . . . . . . . . 62
2.1 Intended use of the scale. . . . . . . . . . . . . . . . . 62
2.2 Description of function . . . . . . . . . . . . . . . . . . . 63
Measuring weight/entering height . . . . . . . . . 63
Network functions. . . . . . . . . . . . . . . . . . . . . 63
Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . 63
2.3 Patient target group. . . . . . . . . . . . . . . . . . . . . 63
2.4 User qualification . . . . . . . . . . . . . . . . . . . . . . . 63
Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Administration/network operation . . . . . . . . . 63
Measuring mode. . . . . . . . . . . . . . . . . . . . . . 63
3. Safety information . . . . . . . . . . . . . . . . . . . . . . . . . 64
3.1 Safety precautions in these instructions for
use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
3.2 Basic safety precautions . . . . . . . . . . . . . . . . . 64
Handling the device . . . . . . . . . . . . . . . . . . . 64
Preventing electric shock . . . . . . . . . . . . . . . 65
Preventing injuries and infections . . . . . . . . . 65
Preventing damage to device . . . . . . . . . . . . 66
Handling measuring results. . . . . . . . . . . . . . 67
Handling packaging material. . . . . . . . . . . . . 67
4. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.1 Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.2 Symbols on the multifunctional display (main
screen) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.3 Symbols on the multifunctional display
(menu) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.4 Markings on the device and on the type
plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.5 Markings on the packaging . . . . . . . . . . . . . . . 73
5. Starting up the device . . . . . . . . . . . . . . . . . . . . . . 74
5.1 Scope of delivery . . . . . . . . . . . . . . . . . . . . . . . 74
5.2 Interfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
5.3 Setting up the device . . . . . . . . . . . . . . . . . . . . 76
5.4 Mounting the multifunctional display on the
positioner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.5 Mounting the multifunctional display on the
wall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
5.6 Connecting the multifunctional display to the
scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
5.7 Connecting a barcode scanner (optional). . . . . 78
5.8 Establishing the power supply . . . . . . . . . . . . . 79
5.9 Installing the drip guard . . . . . . . . . . . . . . . . . . 80
5.10 Adapting device settings . . . . . . . . . . . . . . . . 80
5.11 Transporting the device . . . . . . . . . . . . . . . . . 81
6. Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.1 Activating the multifunctional display . . . . . . . . 82
6.2 Measuring weight . . . . . . . . . . . . . . . . . . . . . . 82
6.3 Entering the height manually . . . . . . . . . . . . . . 83
6.4 Using extended weighing functions . . . . . . . . . 83
Taring additional weight (tare) . . . . . . . . . . . . 83
Permanently displaying the weight (Hold) . . . 84
Permanently storing additional weight
(pre-tare). . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Automatic switchover of weighing range. . . . 86
Automatic calculation of BMI or BSA . . . . . . 86
Entering waist circumference . . . . . . . . . . . . 87
6.5 Completing the measurement procedure. . . . . 87
Devices with connection to an EMR
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Devices with connection to the
seca analytics 125 software . . . . . . . . . . . . . 87
Standalone devices . . . . . . . . . . . . . . . . . . . 88
7. Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
7.1 Basic functions . . . . . . . . . . . . . . . . . . . . . . . . 88
Changing the device mode. . . . . . . . . . . . . . 88
Calling up/exiting a menu . . . . . . . . . . . . . . . 89
Accessing the PDF version of the
instructions for use (QR code). . . . . . . . . . . . 89
7.2 Measuring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Activating the Autohold function . . . . . . . . . . 90
Setting filter . . . . . . . . . . . . . . . . . . . . . . . . . 91
Selecting BMI/BSA/Waist circumf. . . . . . . . . 91
7.3 Adjusting display settings. . . . . . . . . . . . . . . . . 92
Setting the display language. . . . . . . . . . . . . 92
Setting the date format . . . . . . . . . . . . . . . . . 93
Setting the standby time. . . . . . . . . . . . . . . . 93
Setting the display brightness. . . . . . . . . . . . 94
Switching over units . . . . . . . . . . . . . . . . . . . 95
7.4 Setting up network functions . . . . . . . . . . . . . . 95
Setting up the device in the
seca connect 103 software. . . . . . . . . . . . . . 96
Entering the IP address. . . . . . . . . . . . . . . . . 97
Activating/deactivating the WiFi function . . . . 97
Connecting the device to the WiFi network
(seca connect 103) . . . . . . . . . . . . . . . . . . . . 98
Connecting the device to the WiFi network
(WPS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Automatically clearing measured values
(Autoclear) . . . . . . . . . . . . . . . . . . . . . . . . . . 99
7.5 Factory settings . . . . . . . . . . . . . . . . . . . . . . . 100
Overview of factory settings . . . . . . . . . . . . 100
Restoring factory settings . . . . . . . . . . . . . . 100
8. Hygiene treatment . . . . . . . . . . . . . . . . . . . . . . . . 101
8.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
8.2 Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . 101
9. Function check . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
10. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . 102
10.1 General faults. . . . . . . . . . . . . . . . . . . . . . . . 102
10.2 Measuring weight . . . . . . . . . . . . . . . . . . . . 103
10.3 Data transmission . . . . . . . . . . . . . . . . . . . . 104
10.4 Display message traffic light system. . . . . . . 105
10.5 Error codes . . . . . . . . . . . . . . . . . . . . . . . . . 105
English
TABLE OF CONTENTS
Table of contents • 61
English
17-10-07-653-100_01-2020B
11. Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
11.1 Calibrated scales (read off calibration
counter and GAL value) . . . . . . . . . . . . . . . . . 105
11.2 Non-calibrated scales . . . . . . . . . . . . . . . . . 106
12. Technical data. . . . . . . . . . . . . . . . . . . . . . . . . . . 107
12.1 Menu structures. . . . . . . . . . . . . . . . . . . . . . 107
“Basic” device mode. . . . . . . . . . . . . . . . . . 107
“Advanced” device mode . . . . . . . . . . . . . . 107
“Expert”/“Service” device modes . . . . . . . . 108
12.2 Functions/device mode . . . . . . . . . . . . . . . . 109
12.3 General technical data . . . . . . . . . . . . . . . . . 109
12.4 Dimensions, weight . . . . . . . . . . . . . . . . . . . 110
12.5 Weighing technology data,
calibrated models . . . . . . . . . . . . . . . . . . . . . 110
12.6 Weighing technology data, non-calibrated
models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
13. Optional accessories and spare parts . . . . . . . 111
14. Compatible seca products . . . . . . . . . . . . . . . . 111
15. Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
16. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
17. Declaration of conformity . . . . . . . . . . . . . . . . . 112
17.1 Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
17.2 USA and Canada. . . . . . . . . . . . . . . . . . . . . 112
62 • seca 651/650
17-10-07-653-100_01-2020B
1. ABOUT THIS DOCUMENT
1.1 Display conventions
Display in the text
Display in graphics
1.2 PDF version
The device menu contains a QR code which can be used to access the PDF
version of these instructions for use and load them e.g. onto your smartphone
or tablet PC.
Further information is available here: ➔ Accessing the PDF version of the
instructions for use (QR code), page 89
2. DESCRIPTION OF DEVICE
2.1 Intended use of the scale
The seca scale is mainly used in hospitals, medical practices, outpatient and
inpatient health care facilities, and in medically oriented fitness facilities in
accordance with national regulations.
The seca scale is used for the conventional determination of weight and
establishment of the general state of nutrition; it assists the physician super-
vising treatment in making a diagnosis or deciding on a course of treatment.
Symbol Description
►Action
1.
2. Actions to be perfomred in the specified sequence
a)
b)
Steps of an action that have to be performed in the
specified sequence
•
•First level of a list
–
–Second level of a list
Symbol Description
Indicates points on the device or on device
components which require particular attention
Indicates directions of movement of the device or
device components
Navigation path in menu displays
Correct action
Correct result
Incorrect action
Incorrect result
Points to the next step of a procedure
End of a procedure, e.g. the installation of a part
Description of device • 63
English
17-10-07-653-100_01-2020B
To make an accurate diagnosis, however, the physician must order other
specific examinations and take their results into account, in addition to
determining a weight value.
2.2 Description of function
Measuring weight/entering height Weight calculation is carried out with four weighing cells. The measuring
results are shown on the multifunctional display. The height is entered
manually.
The Body Mass Index (BMI) or Body Surface Area (BSA) is automatically
calculated from the “Weight” and “Height” parameters.
Network functions The device can be integrated into a PC network via a LAN interface or via
WiFi. The seca connect 103 is required to set up this integration.
The seca connect 103 software receives measurement data from the device
and forwards them to an EMR System or to the seca analytics 125 software.
The seca analytics 125 software receives measurement data from the
seca connect 103 software and processes them graphically. The software
therefore assists the physician supervising treatment in evaluating measuring
results or making a diagnosis.
Compatibility Configuration software: seca connect 103: Version 2.0 or higher, no
downward compatibility.
Evaluation software: seca analytics 125: Version 1.0 or higher.
2.3 Patient target group
The device is intended for persons of any age, with the exception of babies.
Limitations in terms of weight and height can arise depending on the compat-
ible seca products used:
➔ Technical data, page 107
➔ Compatible seca products, page 111
2.4 User qualification
Assembly Devices that are shipped partially assembled may only be mounted by suffi-
ciently qualified persons such as specialist dealers, hospital technicians or
seca Service technicians.
Administration/network operation The device may only be set up and incorporated in a network by experienced
administrators or hospital technicians.
Measuring mode The device may only be operated by persons with formal training in the field of
healthcare or medicine.
64 • seca 651/650
17-10-07-653-100_01-2020B
3. SAFETY INFORMATION
3.1 Safety precautions in these instructions for use
DANGER!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries will occur.
WARNING!
Used to identify an extremely hazardous situation. If you fail to take
note of this information, serious irreversible or fatal injuries may result.
CAUTION!
Used to identify a hazardous situation. If you fail to take note of this
information, minor to moderate injuries may result.
NOTICE!
Used to identify possible incorrect usage of the device. If you fail to
take note of this information, you may damage the device, or the mea-
suring results may be incorrect.
NOTE
Includes additional information about use of the device.
3.2 Basic safety precautions
Handling the device ►Please take note of the information in these instructions for use.
►Keep the instructions for use in a safe place. The instructions for use are a
component of the device and must be available at all times.
►In the interest of patient safety, you and your patients are obliged to report
serious events that occur in connection with this product to the manufac-
turer and the authority responsible in your country.
DANGER!
Risk of explosion
Do not use the device in an environment in which one of the following
gases has accumulated:
– Oxygen
– Flammable anesthetics
– Other flammable substances/air mixtures
CAUTION!
Patient hazard, damage to device
►Additional devices which are connected to electrical medical
devices must provide evidence of compliance with the relevant IEC
or ISO standards (e.g. IEC 60950 for data-processing devices).
Furthermore, all configurations must comply with the requirements
of standards for medical systems (see IEC 60601-1-1 or Section 16
of edition 3.1 of IEC 60601-1 respectively). Anyone connecting
additional devices to electrical medical devices is considered a
system configurer and is therefore responsible for ensuring that the
system complies with the requirements of standards for systems.
This also applies to additional devices recommended by seca. Your
attention is drawn to the fact that local laws take precedence over
Safety information • 65
English
17-10-07-653-100_01-2020B
the above-mentioned requirements of standards. In the event of any
queries, please contact your local specialist dealer or Technical
Service.
►Have servicing carried out regularly as described in the relevant
section of this document.
►Technical modifications may not be made to the device. The device
does not contain any parts for servicing by the user. Only have
servicing and repairs performed by an authorized seca Service
partner. .
►Only use original seca accessories and spare parts, otherwise seca
will not grant any warranty.
CAUTION!
Patient hazard, malfunction
►Keep other electrical medical devices, e.g. high-frequency surgical
devices, a minimum distance of approx. 1 meter away to prevent
incorrect measurements or wireless transmission interference.
►Keep HF devices such as cell phones a minimum distance of
approx. 1 meter away to prevent incorrect measurements or
wireless transmission interference.
►The actual transmission output of HF equipment may require
minimum distances of more than 1 meter. Details can be found at
www.seca.com.
Preventing electric shock WARNING!
Electric shock
►Set up the device so that the power supply socket is easy to reach
and the device can be disconnected from the power supply quickly.
►Ensure that your local power supply matches the information on the
power supply unit.
►Do not touch the power supply unit with wet hands.
►Do not use extension cables or power strips.
►Make sure that cables are not pinched or damaged by sharp edges.
►Make sure that cables do not come into contact with hot objects.
►Do not operate the device at an altitude of more than 3000 m above
sea level.
►Only devices which are approved as medical devices and have no
separate power supply may be connected to the USB interface.
Preventing injuries and infections WARNING!
Injury from falls
►Ensure that the device is positioned firmly and level.
►Route connecting cables (if present) in such a way that neither user
nor patient can trip over them.
►Assist people with limited motor skills when they are getting up, e.g.
from a wheelchair.
►Make sure that the patient does not step onto and off the weighing
platform right at the edges.
►Make sure that the patient steps onto and off the weighing platform
slowly and safely.
66 • seca 651/650
17-10-07-653-100_01-2020B
WARNING!
Danger of slipping
►Ensure that the weighing platform is dry before the patient steps
onto it.
►Ensure that the patients feet are dry before he or she steps onto the
weighing platform.
►Make sure that the patient steps onto and off the weighing platform
slowly and safely.
CAUTION!
Hazard to patient, damage to device
The area where the patient stands consists of a glass plate. Damage
to the glass plate, e.g. as a result of scratches, cracks and chips,
presents a risk of injury and can lead to the glass plate breaking.
►Do not put any sharp-edged objects on the glass plate.
►Before using the device each time, check the glass plate for
scratches, cracks and chips. If you find damage of this kind, have
the glass plate replaced with a new one.
►Do not use the device if the glass plate is damaged.
WARNING!
Risk of infection
►Before and after every measurement, wash your hands to reduce
the risk of cross-contamination and nosocomial infections.
►Hygienically reprocess the device regularly as described in the
respective section in this document.
►Make sure that the patient has no infectious diseases.
►Make sure that the patient has no open wounds or infectious skin
alterations, which may come into contact with the device.
Preventing damage to device NOTICE!
Damage to device
►Ensure that fluids and dust never get inside the device and the
sensors. They can damage the electronics.
►Disconnect the power supply unit from the mains socket if you in-
tend to not use the device for a longer period of time. Only this way
it can be ensured that the device is currentless.
►Make sure not to drop the device.
►Do not expose the device to any impacts or vibrations.
►Perform function controls regularly as described in the relevant sec-
tion in this document. Do not operate the device if it is damaged or
not working properly.
►Ensure that there is no heat source in the immediate vicinity. Do not
expose to direct sunlight. The excessive temperature could damage
the electronics.
►Use the device only under the intended ambient conditions.
►Store the device only under the intended storage conditions.
►Observe the information in the technical data concerning cooling
times after storage at very high temperatures or warm-up times after
storage at very low temperatures.
►Use alcohol-based disinfectant (e.g. 70 % ethanol) exclusively.
►Do not use aggressive or abrasive cleaning agents.
Safety information • 67
English
17-10-07-653-100_01-2020B
Handling measuring results CAUTION!
Patient hazard
In order to avoid misinterpretations, measuring results for medical use
must be displayed and used in SI units (weight: Kilograms/grams,
length: Meters/centimeters) only. Some devices offer the ability to dis-
play measuring results in other units. This is only an additional func-
tion.
►Use the results exclusively in SI units.
►The use of measuring results in non-SI units is the sole responsibility
of the user.
NOTICE!
Inconsistent measuring results
►Before you electronically save measured values determined using
this device and use them further (e.g. in seca PC software or in an
EMR system), make sure that the measured values are plausible.
►If measured values are transmitted to seca PC software or an EMR
system, make sure prior to further use that the measured values are
plausible and are assigned to the correct patient.
Handling packaging material WARNING!
Risk of suffocation
Packaging material made of plastic foil (bags) is a choking hazard.
►Keep packaging material out of reach of children.
►In the event that the original packing material may not be available
anymore, only use plastic bags with security holes in order to reduce
the risk of suffocation. Use recyclable materials if possible.
NOTE
Keep the original packing material for future use (e.g. returning for
servicing).
68 • seca 651/650
17-10-07-653-100_01-2020B
4. OVERVIEW
4.1 Controls
3
2
1
6
4
5
7
7
Item Device component Description
1Weighing platform
• Bears the weight of the patient
•Forextensions:seca 464 adapter set required ➔ Optional accessories and spare
parts, page 111
2Workflow LED
Indicates the status of data recording and data transmission (requirement:
Connection to the seca connect 103 software)
• Illuminated in green: Measurement procedure active
• Flashing green (approx. 5 seconds): Measuring results being sent to the EMR
System (depending on setting)
• Illuminated in green (approx. 5 seconds): Measuring results successfully sent to the
EMR System (depending on setting)
• Illuminated in red (approx. 5 seconds): Error during data transmission or
measurement procedure
NOTE
The data recorded and transmitted are specified in the seca connect 103
software. If you have any queries, contact your administrator or hospital
technician
3Foot screw 4 pcs, for precise alignment of the device
4Multifunctional display
Central control and display element
• ➔ Symbols on the multifunctional display (main screen), page 69
• ➔ Symbols on the multifunctional display (menu), page 71
5Positioner Used to position the multifunctional display on a table or for mounting on a wall
6Connection panel Used for power supply and data transmission ➔ Interfaces, page 75
7Recessed handle Used for transporting over short distances (2 pcs)
Overview • 69
English
17-10-07-653-100_01-2020B
4.2 Symbols on the multifunctional display (main screen)
This section contains information about the display content in measuring
mode. Information about the display content for configuration and administra-
tion is available here: ➔ Symbols on the multifunctional display (menu),
page 71.
B
D
E
C
F
IJK
A
H
L
G
Item Display element Description
A
B
IDU
IDP
Only on connection to an EMR System (via seca connect 103):
•IDU: User name
•IDP: Name and date of birth of the patient
• Press the area to display the IDs in enlarged form
• Not available on connection to seca analytics 125
C
WiFi connection status display:
• WiFi activated, no signal
• Signal very weak
• Signal weak
• Signal good
• Signal optimal
LAN connection status display:
• Deactivated
• Activated
• Not available