MCC Medical Chair Scale Operating Instructions Ver 3.02 Dec 2018

GB

KERN MCC Version 3.2 2018-12

Operating manual chair Contents 1

Technical data ... 5

2

Declaration of conformity ... 6

2.1

Explanation of the graphic symbols ... 6

3

Appliance overview ... 9

3.1 3.2 3.3

Overview of display ... 12 Keyboard overview ... 13 Dimensions ... 14

4

Basic Information (General) ... 15

4.1 4.2 4.3 4.4 4.5

Specific function ... 15 Proper use ... 15 Improper Use ... 16 Warranty ... 16 Monitoring of Test Resources ... 17

5

Basic Safety Precautions ... 17

5.1 5.2 5.3 5.4

Pay attention to the instructions in the Operation Manual... 17 Personnel training... 17 Preventing contamination ... 17 Appropriate use ... 17

6

Electromagnetic compatibility (EMC)... 18

6.1 6.2 6.3 6.3.1 6.4

General hints ... 18 Electromagnetic interferences ... 19 Electromagnetic noise immunity ... 20 Crucial features of performance ... 22 Minimum distances ... 22

7

Transport and storage ... 23

7.1 7.2

Testing upon acceptance ... 23 Packaging / return transport ... 23

8

Unpacking, Setup and Commissioning ... 24

8.1 8.2 8.3 8.4 8.4.1 8.5 8.5.1 8.6 8.7

Place of installation / place of operation ... 24 Unpacking ... 24 Scope of delivery ... 24 Installing the chair scales ... 25 Levelling ... 26 Mains connection... 28 Safety cable ... 28 Rechargeable battery operation ... 29 Battery operation ... 30

MCC-NM-BA-e-1832

3

8.8

Initial Commissioning... 31

9

Operation ... 32

9.1 9.2 9.3 9.4 9.6 9.6.1 9.7 9.8

Weighing ... 32 Taring... 33 HOLD function ... 34 See second decimal point (not verified value) ... 34 Calculation of the Body Mass Index ... 35 Classification of BMI values ... 35 Automatic switch-off function „AUTO OFF“ ... 36 Display background illumination ... 37

10

Menu ... 38

10.1 10.2

Navigation in the menu ... 38 Menu overview ... 39

11

Error messages ... 40

12

Service, maintenance, disposal ... 41

12.1 12.2 12.3 12.4 12.5

Cleaning ... 41 Cleaning / disinfecting ... 41 Sterilisation ... 41 Service, maintenance ... 41 Disposal ... 41

13

Instant help... 42

14

Verification ... 43

14.1

Verification validity period (current status in G) ... 44

15

Adjustment ... 45

16

Accessories ... 47

17

Printers ... 47

4

MCC-NM-BA-e-1832

1 Technical data KERN (Type) Model

MCC 250K100NM MCC 250K100M

Readability (d)

0.1 kg

Weighing range (max)

250 kg

Minimum weight (min)

2 kg

Verification value (e)

100 g

Verification class

III

Reproducibility

0.1 kg

Linearity

±0.1 kg

Recommended adjustment weight (Class)

200 kg (M1)

Weighing Units

kg

Warm-up time

10 min

Electric Supply

Input voltage: 100 V - 240 V AC 50 Hz

Operating temperature Humidity of air Dimensions (W x D x H) mm Dimensions Weighing surface

0°C … + 40°C max. 80 % (not condensing) 625 x 990 x 985 507 x 380

Weight kg (net)

23.3

Rechargeable battery operation

Series

Medical product in accordance with 93/42/EEC

Category I with measuring function

Verification according to 2014/31/EU

MCC-NM-BA-e-1832

class III

5

2 Declaration of conformity To view the current EC/EU Declaration of Conformity go to:

www.kern-sohn.com/ce

The scope of delivery for calibrated weighing balances (= conformity-rated weighing balances) includes a Declaration of Conformity. Solely these weighing balances are classified as medical devices. 2.1

Explanation of the graphic symbols All medical scales marked in this way meet the requirements of the following directives: 1. 2014/31/EU: Directive on non-automatic weighing instruments 2. 93/42/EC: Directive concerning medical devices Scales marked in this way underwent the conformity assessment procedure according to Directive 2014/31/EU for scales belonging to 3rd accuracy class.

WF 1734331

Designation of the serial number of every device, applied at the device and on the packaging Number here as example Identification of the manufacturing date of the medical product. Year and month here as example

2018-12

6

MCC-NM-BA-e-1832

“Please note the accompanying documents“ or “Please note operating instructions”

“Please note operating instructions”

“Please note operating instructions”

Identification of manufacturer of medical product including address Kern & Sohn GmbH D–72336 Balingen,Germany www.kern-sohn.com

“Electro-medical appliance“ with attachment for type B

Device protection category II

Dispose of old appliances separately from your household waste! Instead, take them to communal collection points.

12 V DC / 500 mA

MCC-NM-BA-e-1832

Display of supply voltage for scales with polarity display.

7

Do not use the chair scales to transport people and objects! Do not stand on the footrests when you get on or off the chair scales!

After taking chair scales to patient, ensure scales are level before starting the weighing process.

Power connection

Seal KERN SEAL

Supply voltage current

Information

Level the balance before use

8

MCC-NM-BA-e-1832

3 Appliance overview

1. 2. 3. 4. 5. 6. 7. 8. 9.

MCC-NM-BA-e-1832

Seat pan Bubble level Display Unit Manipulations Parking brake Adjustment switch Terminal power supply unit Connection cable "Display - Chair" Battery compartment

9

Details:

Accessory bag

Parking brake open

Parking brake closed

Foot rest and adjustment foot

10

MCC-NM-BA-e-1832

Folding arm rests

MCC-NM-BA-e-1832

11

3.1

Overview of display

Display

Description

Description

GROSS

Gross weight display

Lights up during indication of the gross weight

NET

Net weight display

Lights up during indication of the net weight Illuminated after weighing scale was tared

ZERO

Zeroing display

Should the balance not display exactly zero despite empty scale pan, press the button. Your balance will be set to zero after a short standby time.

STABLE BMI HOLD

Stability display

Scales are in a steady state

Body Mass Index

Is actively displayed during active BMI function

HOLD function

Is displayed with active hold function Lights when the voltage drops below the prescribed minimum.

Rechargeable battery symbol

Lights when the rechargeable battery capacity is almost exhausted. Lights when the rechargeable battery is fully charged.

12

MCC-NM-BA-e-1832

3.2

Keyboard overview

Key

Description

Function

ON/OFF-switch

Turn on/off

HOLD button

Hold function

BMI key

Calculation of the Body Mass Index In menu: • Confirm selection For numeric entry: • Confirm numerical value

Function key

In menu: • Call up menu • How to select menu items For numeric entry: •

Increase numerical value

Zero setting key

Weighing scale will be reset to „0.0“ For numeric entry: • Change decimal place

TARE key

Tare balance

MCC-NM-BA-e-1832

13

3.3

14

Dimensions

MCC-NM-BA-e-1832

4 Basic Information (General)

Weighing instruments have to be verified for the purposes stated below in accordance with Directive 2014/31/EU. Article 1, paragraph 4. “Determination of mass in the practice of medicine that is, weighing patients for reasons of medical supervision during medical surveillance, examination and treatment.” 4.1

Specific function Indication • Determining the body weight in the medical practice area. • Use as „non-standalone weighing scale“, that is, a person sits carefully onto the seating surface’s centre. Once a steady display value is shown, you can read the weight value.

Contraindication •

No contraindication known

4.2 Proper use These scales are used to determine weight of people sitting at rest in medical treatment rooms. The scales are suitable for recognising, preventing and controlling illnesses. The person should be weighed carefully and have contact with the center of the seat, sit and stay calm. As soon as a stable weighing value is reached the weighing value can be read. The scales are designed for long-term usage.

The instruments shall only be used by people who can sit still.

The balances should be checked for correct condition prior to each utilisation by a person familiar with proper operation of the balance.

MCC-NM-BA-e-1832

15

• • • • • •

Do not use the chair scales to transport people and objects! Until the weighed person stays on the chair scales, the wheel brakes must always be activated. The armrests of the chair scales are designed solely for resting arms and not for supporting. When going off and on, a trained person should fold the armrests up (raise) and help the weighed person. The chair scales should always be placed on flat, smooth surface. Do not stand on the footrests when you get on or off the chair scales!

4.3 Improper Use Do not use these scales for dynamic weighing processes. No permanent load on the seat area. This may damage the measuring system. Impacts and overloading exceeding the stated maximum load (max) of the seating surface, minus a possibly existing tare load, must be strictly avoided. This could cause damage to the balance. Never operate balance in explosive environment. The serial version is not explosion protected. It should be noted that a flammable mixture of anaesthetics and oxygen or laughing gas may occur. Do not modify the construction of the scales. This may lead to incorrect weighing results, safety-related faults and destruction of the balances. The balances may only be used according to the described conditions. Other areas of use must be released by KERN in writing. 4.4 Warranty Warranty claims shall be voided in case •

Our conditions in the operation manual are ignored

•

The appliance is used outside the described uses

•

Modification or opening of appliances

•

Mechanical damage and damage caused by media, liquids,

•

Natural wear and tear

•

The appliance is improperly set up or incorrectly electrically connected

•

The measuring system is overloaded

•

Dropping of scales

16

MCC-NM-BA-e-1832

4.5 Monitoring of Test Resources In the framework of quality assurance the measuring-related weighing properties of the balances and, if applicable, the testing weight, must be checked regularly. The responsible user must define a suitable interval as well as type and scope of this test. Information is available on KERN’s home page (www.kern-sohn.com with regard to the monitoring of balance test substances and the test weights required for this. In KERN’s accredited DKD calibration laboratory test weights and balances may be calibrated (return to the national standard) fast and at moderate cost.

5 Basic Safety Precautions 5.1

Pay attention to the instructions in the Operation Manual  Carefully read this operation manual before setup and commissioning, even if you are already familiar with KERN balances.

5.2

Personnel training

The medical staff must apply and follow the operating instructions for proper use and care of the product. 5.3 Preventing contamination The prevention of cross-contamination (fungal skin infections,……) requires regular cleaning of the seating surface. Recommendation: after a weighing procedure that could potentially result in contamination (e. g. after weighing that involves direct skin contact). 5.4

Appropriate use Do not use the chair scales to transport people or objects!

•

Always get on and off the chair scales in the presence of a qualified person (see Chapter 5.2)

•

Before every use inspect the scales for any signs of damage.

•

Maintenance and repeated verification Chair scales should be maintained and verified at regular intervals (see chapter 12.4)

MCC-NM-BA-e-1832

17

6 Electromagnetic compatibility (EMC) 6.1

General hints The installation and use of this electrical medical device requires special precautionary measures as outlined in the EMC information below.

This device complies with the limits set for medical electrical devices of group 1, class B (as per EN 60601-1-2). Electromagnetic compatibility (EMC) describes a device’s ability to perform reliably within an electromagnetic environment without causing inadmissible electromagnetic interference at the same time. Amongst other things, such disturbances may be emitted by connecting cables or the air. Inadmissible disturbances from the environment may result in incorrect displays, inaccurate measured values or incorrect behaviour of the medical device. By the same token the medical device may in some cases cause such disturbances in other devices. To eliminate problems of that kind, we recommend you to take one or several of the measures listed below: • • • •

Change the alignment or distance of the device to the source of EMI. Install or use the chair scale MCC-NM at a different location. Connect the chair scale MCC-NM to a different power source. For further questions please contact our customer services.

Disturbances may be caused by improper modification or add-ons to the device or not recommended accessories (such as power units or connecting cables). The manufacturer will not be responsible for these. Modifications may also result in a loss of authorisation relating to the use of the device. Devices emitting high frequency signals (mobile telephones, radio transmitters, radio receivers) may cause interference in the medical device. For that reason do not use them near the medical device. Chapter 6.4 contains details about recommended minimum distances.

18

MCC-NM-BA-e-1832

6.2

Electromagnetic interferences

Guidelines and manufacturer’s declaration – electromagnetic interferences The chair scale MCC-NM is designed for use in an electromagnetic environment that meets the requirements stated below. The customer or user of the medical electrical device must ensure that operation takes place in such an environment. Emitted interference measurements

Conformity

Electromagnetic environment guideline

HF emissions

Group 1

The chair scale MCC-NM uses HF energy merely for its internal working. Its HF emission therefore is very low and it is highly unlike to interfere with adjacent electronic devices.

Class B

The chair scale MCC-NM is designed for use in all equipment including those in living areas and those connected directly to the public power grid that also supplies buildings used for living purposes.

as per CISPR 11 / EN 55011

HF emissions as per CISPR 11 / EN 55011 Emission of harmonics

Class A

as per IEC 61000-3-2 Emission of voltage fluctuations / flicker

Conforms with

as per IEC 61000-3-3 Do not put the chair scale MCC-NM directly next to other devices and do not stack it with other devices. If this type of operation is necessary, observe the chair scale MCC 250K100M to ensure normal operation in such an arrangement.

MCC-NM-BA-e-1832

19

6.3

Electromagnetic noise immunity

Guidelines and manufacturer’s declaration - electromagnetic noise immunity The chair scale MCC-NM is designed for use in an electromagnetic environment that meets the requirements stated below. The customer or user of the medical electrical device must ensure that operation takes place in such an environment. Noise immunity tests

IEC 60601 test level

Conformity

Electromagnetic environment - guideline

Discharge static electricity (DSE)

± 6 kV contact discharge

± 6 kV

± 8 kV air discharge

± 8 kV

Floors should be made of wood or concrete or tiled with ceramic tiles. If floors are covered with synthetic material, relative air humidity must be at least 30%.

± 2 kV for power lines

± 2 kV

+ 1 kV for input and output lines

+ 1 kV

as per IEC 61000-4-4 Impulse voltages / surges

± 1 kV voltage Live wire - live wire

± 1 kV

as per IEC 61000-4-5

± 2 kV voltage Live wire - earth

Inapplicable

Voltage dips, short-term disruptions and fluctuations in supply voltage

<5% (> 95 % dip of for ½ period

)

40 % (> 60 % dip of for 5 periods

)

70 % (> 30 % dip of for 25 periods

)

<5% (> 95 % dip of for 5 s

)

as per IEC 61000-4-2

Fast transient electrical disturbances / bursts

as per IEC 61000-4-11

Magnetic field for supply frequency (50/60 Hz) as per IEC 61000-4-8

NOTE

20

3 A/m

Compliance with requirements under all postulated conditions

Controlled switch off Return to undisturbed situation after user intervention. 3 A/m 50/60 Hz

The quality of the supply voltage should match that of the typical business or hospital environment. The quality of the supply voltage should match that of the typical business or hospital environment.

The quality of the supply voltage should match that of the typical business or hospital environment. Where the user of the chair scale MCC-NM demands continuous operation even during disruptions to the power supply, we recommend powering the chair scale MCCNM by no-break power supply or battery.

Magnetic fields for the supply frequency should match the typical values found in the particular business or hospital environment.

equals AC line voltage prior to application of test level.

MCC-NM-BA-e-1832

Guidelines and manufacturer’s declaration - electromagnetic noise immunity The chair scale MCC-NM is designed for use in an electromagnetic environment that meets the requirements stated below. The customer or user of the medical electrical device must ensure that operation takes place in such an environment. Noise immunity tests

IEC 60601 test level

Conformity

Electromagnetic environment guideline

Conducted HF disturbance variables

3 150 kHz to 80 MHz

3V

3 80 MHz to 2.5 GHz

3 V/m

Do not use portable or mobile radio sets nearer to the chair scale MCC-NM or its wires than the distance recommended as safety distance which is calculated according to the equation relevant for its transmission frequency.

as per IEC 61000-4-6 Emitted HF disturbance variables

Recommended safety distance: as per IEC 61000-4-3

for 80 MHz to 800 MHz

for 800 MHz to 2.5 GHz Use P as rated capacity of radio transmitter in Watt (W) as per details given by the radio transmitter manufacturer and d as recommended safety distance in metres (m). The field intensity of stationary radio transmitters should for all frequencies be a lower according to an in situ b examination than the conformity level. Interference may occur near devices bearing the symbol below. NOTE 1 NOTE 2

Higher frequency range applies to 80 MHz and 800 MHz. These guidelines may not be applicable in all cases. The spread of electromagnetic variables is influenced by absorption and reflections in buildings, objects and humans.

a

The field intensity of stationary radio transmitters such as base stations of wireless telephones and mobile radio sets, amateur radio stations, AM and FM radio and television stations cannot be reliably predicted in advance. To determine the electromagnetic environment in respect of stationary transmitters, you should consider a study of electromagnetic phenomena at the location. If the measured field intensity at the location where the chair scale MCC-NM is to be used exceeds the conformity level above, you should observe the chair scale MCC-NM in order to ensure normal operation. If you observe unusual features of performance you may have to take additional measures such as a change in alignment or a different location for the chair scale MCC-NM.

b

For a frequency range of 150 kHz to 80 MHz field intensity should be less than 3 V/m.

MCC-NM-BA-e-1832

21