Instructions for use
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Page 1
seca 955 Instructions for use
English
CONTENTS English 1. Description of device... 3
Displaying weight permanently (HOLD)... Determining Body Mass Index (BMI)... Automatic switchover of weighing range . . . Switching off the device... 5.2 Other functions (menu)... Navigating in the menu... Clearing stored values automatically (ACLr) . Permanently storing additional weight (Pt) . . Activating the Autohold function (AHOLd) . . Activating acoustic signals (bEEP)... Selecting attenuation (FIL)... Restoring factory settings (rESEt)...
1.1 Intended use... 3 1.2 Description of function... 3 1.3 User qualification... 3 2.
Safety information... 3 2.1 Safety precautions in these instructions for use... 2.2 Basic safety precautions... Handling the device... Preventing electric shock... Preventing injuries and infections... Preventing damage to device... Handling measuring results... Handling packaging material... Handling batteries and rechargeable batteries...
3.
3 4 4 5 5 6 6 7 7
Overview... 8 3.1 View of device... 8 3.2 Symbols in the display... 9 3.3 Markings on the device and on the type plate... 10 3.4 Markings on the packaging... 11 3.5 Menu structure... 12
4.
Starting up device... 13 4.1 Scope of delivery... 4.2 Establishing the power supply... Inserting the rechargeable battery block... Connecting the power supply unit... 4.3 Aligning the scale...
5.
13 13 13 14 14
Operation... 15 15 15 16 16
Hygiene treatment... 21 6.1 Cleaning... 21 6.2 Disinfection... 22 6.3 Sterilizing... 22
7.
Function check... 22
8.
What to do if …?... 23
9.
Servicing/verification... 24 9.1 Information on servicing and verification... 24 9.2 Checking the content of the verification counter... 24
10. Technical data... 25 10.1 General technical data... 25 10.2 Weighing data... 26 11. Spare parts... 26 12. Disposal... 26 12.1 Device... 26 12.2 Batteries and rechargeable batteries... 26 13. Warranty... 27 14. Declaration of conformity... 27
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5.1 Weighing... Switching on the device... Starting the weighing procedure... Taring off additional weight (TARE)...
6.
17 17 17 18 18 18 19 19 20 20 20 21
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English
1. DESCRIPTION OF DEVICE 1.1 Intended use The medical scale is mainly used at hospitals, practices and inpatient care facilities in accordance with national regulations. The scale seca 955 is for conventional determination of weight and establishment of general state of nutrition; it assists the physician supervising treatment in making a diagnosis or deciding on a course of treatment. To make an accurate diagnosis, however, other specific examinations have to be ordered by the physician and their results taken into account, in addition to determining a weight value.
1.2 Description of function The scale is used to determine weight. Some versions of these scales allow you to switch the weight display between kilos (kg), pounds (lbs) and stones (sts). The height value can be entered manually to calculate the body mass index. The seca 955 is not intended for the transport of people or objects.
1.3 User qualification The device may only be operated by healthcare professionals.
2. SAFETY INFORMATION 2.1 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 measuring results may be incorrect. NOTE Includes additional information about use of the device.
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Description of device • 3
2.2 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. 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 devic-
es 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. Your attention is drawn to the fact that local laws take precedence over the above-mentioned requirements of standards. In the event of any queries, please contact your local specialist dealer or Technical Service.
► Have servicing and verification 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. You can find service partners in your area at www.seca.com or by sending an e-mail to service@seca.com.
► 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 ap-
prox. 1 meter away to prevent incorrect measurements or wireless transmission interference.
► The actual transmission output of HF equipment may require mini-
mum distances of more than 1 meter. Details can be found at www.seca.com.
CAUTION! ► Use the chair scale only under the supervision of specialist staff. ► Prior to each use, ensure that the wheel brakes work properly. ► Secure the scales against accidental rolling. Lock the wheel brakes. ► Do not transport any persons or objects with the chair scales. ► Move the scales only with the wheel brakes released.
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Patient hazard, damage to device
English
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.
Preventing injuries and infections
NOTICE! Incorrect measurement due to force shunts
If accessories (e.g. power supply pouch) or pieces of clothing become trapped between the seat and the base frame, the weight will not be measured correctly. If the patient's feet are not on the footrests, the weight measurement will be incorrect. ► Ensure that there are no objects between the seat and the base frame. ► Ensure that the armrests are folded down during the weighing pro-
cess.
► Make sure that the patient's feet are placed on the footrests during
the weighing process.
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.
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Safety information • 5
Preventing damage to device
NOTICE! Damage to device ► Ensure that no liquids enter the device. They can damage the elec-
tronics.
► Switch off the device before disconnecting the power supply unit
from the mains socket.
► For devices with power supply operation: Disconnect the power
supply unit from the mains socket if you intend to not use the device for a longer period of time. Only this way it can be ensured that the device is de-energized.
► For devices with battery or rechargeable battery operation: If you do
not use the device for an extended period of time, remove batteries or rechargeable batteries. Only this way it can be ensured that the device is de-energized.
► 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.
► Avoid rapid temperature fluctuations. When the device is transport-
ed so that a temperature difference of more than 20 °C occurs, it must stay turned off for at least 2 hours before it can be turned on again. Otherwise, condensation water will form which can damage the electronics.
► Use the device only in intended ambient conditions. ► Store the device only in the intended storage conditions. ► Use only chlorine and alcohol-free disinfectants which are explicitly
suitable for acrylic sheet and other sensitive surfaces (active ingredient: quaternary ammonium compounds, for example).
► Do not use aggressive or abrasive cleaning agents. ► Do not use organic solvents (e.g. white spirit or petroleum spirit).
Handling measuring results
WARNING! Patient hazard
This device is no diagnostic device. It simply assists the treating physician in establishing a diagnosis. ► In order to make a precise diagnosis and initiate therapeutic measures, besides determination of the weight, further targeted examinations must be set up by the physician, and their results must be considered. ► The responsibility for diagnosis and treatment lies with the treating
physician.
NOTICE! Inconsistent measuring results
this device and use them further (e.g. in seca PC software or in a hospital information system), make sure that the measured values are plausible.
► If measured values are transmitted to seca PC software or a hospital
information system, make sure prior to further use that the measured values are plausible and are assigned to the correct patient.
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► Before you electronically save measured values determined using
English
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).
Handling batteries and rechargeable batteries
WARNING! Personal injury as a result of improper handling
Batteries and rechargeable batteries contain harmful substances which may explode if not handled properly. ► Do not try to recharge batteries. ► Do not expose (rechargeable) batteries to heat. ► Do not burn (rechargeable) batteries. ► If acid is leaking out, avoid contact with the skin, eyes and mucous
membranes. Rinse affected areas with plenty of clean water and seek medical help at once.
NOTICE! Damage to device and malfunctions with improper handling ► Only use the type of (rechargeable) battery specified in this
document.
► When replacing (rechargeable) batteries, always replace a complete
set at a time.
► Do not short-circuit (rechargeable) batteries. ► If you do not use the device for a long period of time, remove the
batteries (incl. rechargeable batteries). This prevents acid from leaking into the device.
► If acid leaked into the device, discontinue use. Have the device
checked by an authorised seca Service partner and repaired if necessary.
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Safety information • 7
3. OVERVIEW 3.1 View of device 5 1 2 3 4
7
6 10
8
9
11 12 13 Function
1
ON/OFF key To switch the device off and on
2
Arrow key • While weighing: - Short press: Activate hold function - Long press: Activate tare function • In the menu: - Select submenu, select menu element - Increase value
tare
3
Arrow key • During weighing: - Press briefly: Activate BMI function - Hold down: Call up menu • In the menu: - Select submenu, select menu item - Reduce value
4
Enter key - Confirm selected menu element - Save set value
5
Display
6
Battery compartment
Accommodation for the rechargeable battery block
7
Power supply unit connection
Serves to connect the included power supply unit
8
Spirit level
9
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Device component
Transport rollers
Display element for measuring results and for device configuration
Indicates whether device is horizontal • Steerable • Height adjustable • With wheel brakes • The scale can be moved on these rollers. • The scale can be aligned precisely with these rollers.
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Pos.
English
Pos.
Device component
Function
10
Armrests
Can be folded toward the back, so that it is easier for the patient to sit down
11
Footrests
• Can be folded up/down • For correct measurement, the patient’s feet must be on the footrests
12
Foot screw
2 screws, for precise alignment of device
13
Transport rollers
The scales can be moved about with these rollers
3.2 Symbols in the display A B C D Pos.
Symbol
Meaning
A
Rechargeable battery block is weak
B
Operation with power supply unit
C
Non-verifiable function active
D
Currently used weighing range
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Overview • 9
3.3 Markings on the device and on the type plate Text/symbol
Meaning Name and address of manufacturer, date of manufacture Model number Serial number, consecutive
GAL
Value in m/s² (verified models) • Gravitational acceleration on earth • Depends on the intended location
ProdID
Product identification number, consecutive
Approval Type
Type designation of design approval Follow instructions for use Electrical medical device, type B
e
Value in mass units (verified models) • States the difference between two consecutive display values • Used to classify and verify a scale
x
Weighing range (verified models)
M18 0102 0123
Device complies with EU standards and directives. • M: Conformity label according to Directive 2014/31/EU governing non-automatic weighing instruments (verified models) • 18: (Example: 2018) Year in which conformity verification was performed and the CE label was applied (verified model) • 0102: Notified body metrology (verified models) • 0123: Notified body medical products Class III scale to Directive 2014/31/EU and OIML R76-1 (verified models)
xx V max. xxx mA use compatible seca adapter only
Type plate on the power supply connection socket • x-y V: Supply voltage required • max xx A: Maximum current consumption • •
: Note polarity of connector plug : Operate device with direct current
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Do not dispose of device with household waste
10 •
English
3.4 Markings on the packaging Protect from moisture Arrows indicate top of product Transport and store in an upright position Fragile Do not throw or drop Permitted min. and max. temperature for transport and storage Permitted min. and max. humidity for transport and storage Open packaging here Packaging material can be disposed of through recycling programs
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Overview • 11
3.5 Menu structure Other functions are available in the menu of the device. This enables you to configure the device perfectly to suit the conditions in which you use it (details from page 18).
Reset • On
Autoclear
• Off PT
PT Weight
Net Weight
• On Autohold
Beep
• Off
Press
• On • Off
Hold
• On • Off
•0 Fil
•1 •2
Navigation:
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Call up menu:
12 •
English
4. STARTING UP DEVICE 4.1 Scope of delivery b
a
c
d
Pos. a b c d
Components Scale Power supply unit Rechargeable battery block Power supply unit carrier pouch seca 471 Instructions for use, not shown
Pcs. 1 1 1 1 1
4.2 Establishing the power supply Power is supplied to the scale with a rechargeable battery block or a power supply unit (both included in the scope of delivery).
Inserting the rechargeable battery block 1. Press on latch of battery compartment. 2. Move down lid of battery compartment. 3. Remove the connector cable from the battery compartment. 4. Connect the connector cable to the rechargeable battery block. 5. Insert the rechargeable battery block into the battery compartment. 6. Close the battery compartment.
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Starting up device • 13
Connecting the power supply unit
The rechargeable battery compartment is charged with the included power supply unit. WARNING! Personal injury and damage to device if incorrect power supply unit is used
The voltage provided by standard power supply units may be higher than their indicated rating. This may cause the scales to overheat, catch fire, melt or short-circuit. ► Only use genuine seca plug-in power supply units with 9 V or a controlled 12 V output voltage. 1. Insert the power plug necessary for your power supply in the power supply unit. 2. Insert the connector plug of the power supply unit in the connecting socket of the scales. 3. Plug the power supply unit into a mains socket. 4. Allow the scale to charge on the network for at least 24 hours when it is first charged so that the rechargeable battery block is completely charged.
4.3 Aligning the scale 1. Place the scale on firm and even ground. 2. Align the scale: – with the foot screws on the front transport rollers – with the knurled head screws on the rear transport rollers
The air bubble in the spirit level must be located in the centre of the circle.
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Air bubble Spirit level
14 •
English
5. OPERATION 5.1 Weighing CAUTION! Injury from falls
People with restricted mobility may fall if they try to get onto the scale or to stand up again. ► Route connecting cables (if present) in such a way that neither user nor patient can trip over them. ► Ensure that the wheel brakes on the chair scales are set. ► Support people with restricted mobility as they sit down and stand
up.
► Ensure that the footrests are pushed in (depending on model) and
folded up before the patient gets onto the scale or stands up again.
CAUTION! Injury due to trapping
Hands and arms of the patient and the user can become trapped between seat and base frame as well as between seat and armrests. ► Keep your arms and hands above the seat when you help the patient to sit down. ► Make sure that the patient's hands and arms are placed on the arm-
rests or in his or her lap during the weighing process.
NOTICE! Incorrect measurement due to force shunts
If accessories (e.g. power supply pouch) or pieces of clothing become trapped between the seat and the base frame, the weight will not be measured correctly. If the patient's feet are not on the footrests, the weight measurement will be incorrect. ► Ensure that there are no objects between the seat and the base frame. ► Ensure that the armrests are folded down during the weighing pro-
cess.
► Make sure that the patient's feet are placed on the footrests during
the weighing process.
Switching on the device ► Press the ON/OFF key.
The display will read seca and then quickly run through all elements of the display. The scales are ready for operation when the display reads 0.00. If the device is being operated with a power supply unit, the symbol will appear in the display.
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Operation • 15
Starting the weighing procedure 1. Set the wheel brakes of the rear transport rollers.
2. Fold the armrest toward the back in order to make it easier for the patient to sit down.
3. Make sure that the scale has no load. 4. Switch the scale on. 5. Ask the patient to sit down on the scale. 6. Fold the footrests down. 7. Ask the patient to put his feet on the footrests. 8. Fold the armrests down.
9. Read the measuring result.
Taring off additional weight (TARE)
You can use the TARE function to prevent the weighing result from being affected by an additional weight (e.g. a towel or pad on the weighing surface). NOTICE! Incorrect measurement as a result of force shunt
If an additional weight is in contact with the surface on which the device is resting, measuring results will be incorrect. ► Make sure that additional weights are placed only on the weighing platform. 1. Switch the scale on. 2. Place the additional weight on the scales. tare
4. Wait until the display stops flashing and is replaced by 0.00. 5. Weigh the patient as described in section “Starting the weighing procedure”. 6. Read off the measuring result. The additional weight has been automatically deducted.
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3. Hold down the arrow key hold/tare until “NET” appears in the display.
English
tare
7. To disable the TARE function, press the arrow key hold/tare until “NET” no longer appears in the display or switch off the scales. NOTE The maximum weight that can be displayed is reduced by the weight of the objects already placed on the scales.
Displaying weight permanently (HOLD)
If you activate the HOLD function, the weighing value will continue to be displayed after the load has been removed. This allows you to attend to the patient before noting down the weight. 1. Check that there is no load on the scales. 2. Switch the scale on. 3. Weigh the patient as described in section “Starting the weighing procedure”. 4. Briefly press the arrow key hold/tare.
tare
The display will flash until a stable weight is measured. The weighing value will then be displayed continuously. The symbol (non-verifiable function) and the message “HOLD” will be displayed.
tare
5. To disable the HOLD function, briefly press the arrow key hold/tare. The symbol and the message “HOLD” will no longer be displayed. NOTE If the auto hold function is activated, the weight value is displayed permanently automatically until the scale switches itself off or is switched off ((see “Activating the Autohold function (AHOLd)” on page 20)).
Determining Body Mass Index (BMI)
The body mass index compares height and weight. 1. Check that there is no load on the scales. 2. Switch the scale on. 3. Briefly press the arrow key bmi/menu. The message “BMI” appears. Arrows can be seen flashing in the display. The height last entered is displayed.
tare
4. You can either accept this height or select another value using the arrow keys. 5. Confirm your selection with the Enter key. 6. Weigh the patient as described in section “Starting the weighing procedure”. 7. Read off the BMI. 8. To disable the BMI function, briefly press the Enter key.
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Automatic switchover of weighing range
The scales are equipped with two weighing ranges. Weighing range 1 ( ) offers a more precise weight indication with a reduced load-bearing capacity. Weighing range 2 ( ) allows you to take advantage of the maximum loadbearing capacity of the scales. When the scales are switched on, weighing range 1 is activated. If a specific weight value is exceeded, the scales automatically switch to weighing range 2.
Operation • 17
To switch back to weighing range 1 proceed as follows: ► Remove all loads on the scales.
Weighing range 1 is activated again.
Switching off the device ► Press the ON/OFF key.
NOTE In rechargeable battery operation, the scale switches off after a short time if there is no load on it.
5.2 Other functions (menu) Other functions are available in the menu of the device. This allows you to configure the scales perfectly to your own needs.
Reset
Autoclear
• On • Off
PT
PT Weight
Net Weight
• On Autohold
Beep
• Off
Press
• On • Off
Hold
• On • Off
•0 Fil
•1 •2
1. Switch on the scale. 2. Hold down the arrow key bmi/menu until the menu is called up. The last menu item selected is shown in the display (here: Autohold “AHOLd”).
tare
18 •
3. Keep pressing one of the arrow keys until the required menu item appears in the display (here: attenuation “FIL”).
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Navigating in the menu
English
4. Confirm your selection with the Enter key. The current selection for the menu item or a submenu is displayed (here level “0”). tare
5. To change your selection or call up another submenu, keep pressing one of the arrow keys until the required selection is displayed (here: level “2”). 6. Confirm the selection with the Enter key. You will leave the menu automatically. 7. To make further selections, call up the menu again and proceed as described above. NOTE If no key is pressed for approx. 24 seconds, you will leave the menu automatically.
Clearing stored values automatically (ACLr)
To avoid storing obsolete measuring results in the device memory and so calculating the BMI incorrectly, you can set the scales to ensure measured values are automatically cleared after 5 minutes. NOTE With certain models this function is already activated at the factory. If required, you can disable this function. 1. Select the item “ACLr” in the menu. 2. Confirm the selection. 3. Select the setting you require: – On – Off 4. Confirm the selection. You will leave the menu automatically.
Permanently storing additional weight (Pt)
You can use the Pre-Tare function to permanently store an additional weight and automatically deduct it from the measuring result. You can for example store a flat-rate figure as the weight of shoes and clothing and then always deduct it from the measuring result when a patient is weighed fully dressed. 1. Select the item “Pt” in the menu. The message “Pt” appears. 2. Confirm your selection. Arrows can be seen flashing in the display. The additional weight last stored is displayed. 3. You can accept the stored value or adjust it using the arrow keys. NOTE If you enter the value “0”, the function will be switched off. The message “Pt” will no longer be displayed. 4. Confirm your selection. 5. Ask the patient to sit down on the scale. The patient's weight is displayed. The additional weight stored has been automatically deducted. 6. To disable this function, select the item “Pt” in the menu again.
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7. Confirm your selection. The function is disabled. You will leave the menu automatically. NOTE When you switch the scale off, the function is switched off. The message “Pt” is no longer displayed when you switch the scale on again.
Operation • 19
Activating the Autohold function (AHOLd)
If you activate the Autohold function, the measuring result for each weighing operation will continue to be displayed after the load has been removed. This means you no longer have to manually activate the Hold function for every weighing operation. NOTE With certain models this function is already activated at the factory. If required, you can disable this function. 1. Select the item “AHOLd” in the menu. 2. Confirm the selection. The current selection is displayed. 3. Select the setting you require: – On – Off 4. Confirm your selection. You will leave the menu automatically.
Activating acoustic signals (bEEP)
You can select whether an acoustic signal is to be emitted whenever a key is pressed or a stable weighing value has been attained. The latter is relevant for the Hold/Autohold function. NOTE The function “Acoustic signal with stable weighing value” is activated at the factory. If required, you can disable this function. 1. Select the item “bEEP” in the menu. 2. Confirm the selection. 3. Select a menu item: – PrESS: Acoustic signal whenever a key is pressed – Hold: Acoustic signal with a stable weighing value 4. Confirm your selection. The current selection is displayed. 5. Select the setting you require: – On – Off 6. Confirm your selection. You will leave the menu automatically. 7. If you also wish to activate the acoustic signal for the second function, repeat this procedure.
Selecting attenuation (FIL)
You can use attenuation (FIL = filter) to reduce any interference during weighing (e.g. caused by patient moving). 1. Select the item “FIL” in the menu. 2. Confirm the selection.
FIL 0 1 2
20 •
Weight display Sensitive Medium Slow
Hold Slow Medium Fast
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The current selection is displayed.