seca 645 Instruction Manual Rev B Jan 2016

D

Bedienungsanleitung und Garantieerklärung... 3

GB

Instruction manual and guarantee... 61

FR

Mode d’emploi et garantie... 117

IT

Manuale di istruzioni e garanzia... 175

ES

Manual de instrucciones y garantia... 233

P

Instruções de utilização e declaração de garantia... 289

PL

Instrukcja obsługi i gwarancja... 345 Declaration of conformity for USA and Canada... 404

English English TABLE OF CONTENTS 1. Device description... 63 1.1 Intended use... 63 1.2 Description of function... 63 1.3 User qualification... 63 Assembly... 63 Operation... 64 2. Safety information... 64

Fitting the triangular cover panels... 83 Fitting the caster bar and side bar... 84 Connecting the display cable . 85 4.3 Establishing power supply . . . 86 Connecting the battery block . 86 Connecting the power pack and charging the battery block... 87

2.1 Safety information in these instructions for use... 64 2.2 Basic safety instructions... 64 5. Operation... 88 Handling the instrument... 64 5.1 Setting up the scale... 88 Preventing electric shock... 66 Moving the scale... 88 Avoiding infections... 66 Aligning the scale... 88 Avoiding injuries... 67 Turning the display head... 89 Preventing device damage . . . 67 5.2 Weighing... 90 Handling measuring results . . . 68 Switching on the scale... 90 Handling packaging material . . 69 Weighing a patient... 90 2.3 Handling batteries and Taring off extra weight battery packs... 69 (TARE)... 90 3. Overview... 71 Keeping the measurement result in the display (HOLD) . . . 91 3.1 Controls... 71 Determining and rating body 3.2 Symbols in the display... 72 mass index (BMI)... 92 3.3 Marking on the device and Sending measurement results on the rating plate... 73 to wireless receivers... 93 3.4 Marking on the packaging . . . 74 Calculating and printing out 3.5 Menu structure... 75 BMI automatically... 93 4. Before you really get Automatic switching of started…... 76 weighing range... 94 4.1 Scope of delivery... 76 Switching off the scale... 94 Components... 76 5.3 Other functions (menu)... 95 Connecting elements... 77 Navigating in the menu... 95 4.2 Assembling the device... 78 Deleting saved values Preparing the weighing automatically (ACLr)... 96 platform... 78 Permanently saving an Fitting the right-hand handrail additional weight (Pt)... 96 support... 79 Activating the auto hold Fitting the rear handrail (AHOLd) function... 98 support... 80 Activating beeps (bEEP)... 98 Fitting the handrail... 81 Setting filtering (FIL)... 99 Fitting the display bracket... 82 Restoring factory settings Fitting the display housing... 83 (rESEt)... 99 Table of contents • 61

6. The seca 360° wireless 8. Function check... 108 network... 100 9. Troubleshooting... 108 6.1 Introduction... 100 10. Servicing/Verification... 110 seca wireless groups... 100 10.1 Information on servicing Channels... 101 and verification... 110 Device detection... 101 10.2 Checking the content of the 6.2 Operating the scale in a verification counter... 111 wireless group (menu)... 102 Activating the wireless module (SYS)... 102 Setting up a wireless group (Lrn)... 102 Activating automatic send (ASEnd)... 104 Selecting print option (APrt) . 105 Setting the time (tIME)... 105 7. Hygiene treatment... 106

11. Technical data... 112 11.1 General technical data... 112 11.2 Technical data, weighing . . 113 12. Optional accessories... 113 13. Spare parts... 114 14. Disposal... 114 14.1 Device... 114 14.2 Batteries and rechargeable batteries... 114

7.1 Cleaning... 107 7.2 Disinfecting... 107 15. Warranty... 115 7.3 Sterilizing... 107 16. Declaration of conformity . . . 115

62 •

English

1. DEVICE DESCRIPTION 1.1 Intended use The seca 645 electronic scale with standing aid is mainly used in hospitals, doctors' surgeries and inpatient care facilities in accordance with national regulations. The scale 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 In addition to conventional determination of weight, the seca 645 provides a function for determining body mass index. To this end, height is entered on the keypad and the body mass index associated with the weight value is calculated automatically. Length measuring devices from the seca 360° wireless system can transmit height to the seca 645 wirelessly. Via the seca 360° wireless network, measuring results can be transmitted wirelessly to a seca wireless printer or to a PC equipped with seca analytics PC software and the seca USB wireless adapter. The seca 645 can be moved on casters. Use the scale only for the purpose named in the section entitled “Intended use” on page 63.

1.3 User qualification Assembly

Devices that are shipped partially assembled may only be mounted by sufficiently qualified persons such as specialist dealers, hospital technicians or seca service technicians.

Device description • 63

Operation

The device may only be operated by healthcare professionals.

2. SAFETY INFORMATION 2.1 Safety information 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 measured results may be incorrect. NOTE Includes additional information about use of the device.

2.2 Basic safety instructions Handling the instrument

► Please take note of the information in these instruc-

tions 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.

64 •

English 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 dataprocessing devices). Furthermore, all configurations must comply with the requirements of standards for medical systems (see IEC 60601-1-1 or Section 16 of the 3rd edition 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 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.

Safety information • 65

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 con-

tact with hot objects. ► Do not operate the device at an altitude of

more than 3000 m above sea level.

Avoiding infections

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 scale regularly as

described in the respective section in this document. ► Make sure that the patient has no infectious

diseases. 66 •

English ► Make sure that the patient has no open

wounds or infectious skin alterations, which may come into contact with the device.

Avoiding injuries

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. ► 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. WARNING! Risk of slipping ► Ensure that the weighing platform is dry be-

fore 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.

Preventing device damage

NOTICE! Damage to device ► Ensure that no liquids enter the device. They

can damage the electronics. ► 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 bat-

tery 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.

Safety information • 67

► Do not expose the device to any impacts or

vibrations. ► Perform function controls regularly as de-

scribed in the relevant section 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 im-

mediate vicinity. Do not expose to direct sunlight. The excessive temperature could damage the electronics. ► Avoid rapid temperature fluctuations. When

the device is transported 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 the ambient conditions

outlined in "Intended use". ► Store the device only in the storage condi-

tions outlined in "Intended use". ► Use only chlorine and alcohol-free disinfec-

tants 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.

68 •

English NOTICE! Inconsistent measuring results ► Before you electronically save measurement

values determined using this device and use them further (e.g. in seca PC software or in a hospital information system), make sure that the measurement values are plausible. ► If measurement values are transmitted to

seca PC software or a hospital information system, make sure prior to further use that the measurement 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).

2.3 Handling batteries and battery packs 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.

Safety information • 69

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.

70 •

English

3. OVERVIEW 3.1 Controls 1 2 3 4 5

6

Rear view

9 10

8

7

11 No.

1

Control Function Display housing Central control and display element

2

Switch scale on and off

3

Arrow key • During weighing: - press briefly: activate hold function - press and hold: activate tare function • In the menu: - select submenu, select menu item - increase value

tare

Overview • 71

No.

Control

4

5

6

Display Transport casters Power supply connection Spirit level Battery compartment Foot screw

7 8 9 10 11

Function Arrow key • During weighing: - press briefly: activate BMI function - press and hold: call up menu • In the menu: - select submenu, select menu item - reduce value Enter key • During weighing (if wireless network is set up): - press briefly: send measuring result to devices ready to receive it (PC with USB wireless adapter) - press and hold: print out measuring result (wireless printer) • In the menu: - confirm selected menu item - save set value Display element for measuring results and to configure the device The scale can be moved on these casters. Serves to connect the power pack supplied Shows whether the device is horizontal Contains the battery block 4 pcs, for precise alignment

3.2 Symbols in the display A B C D

2

Symbol

A

Operation with power pack

B

Non-calibratable function active

C D

72 •

Meaning

1 3

2

Memory location currently in use Weighing range currently in use see “Technical data” on page 112

English

3.3 Marking on the device and on the rating plate Text/symbol

Meaning Name and address of manufacturer, date of manufacture Model number Serial number, consecutive

GAL ProdID Approval Type

Value in m/s² (verified models) • Gravitational acceleration on earth • Depends on the intended location Product identification number, consecutive Type designation of design approval Follow instructions for use Electrical medical device, type B

e d

x

Value in units of measurement used to classify and verify a scale Value in units of measurement which gives the difference between two consecutive display values Active weighing range Class III scale to directive 2014/31/EU

M18 0102 0123

FCC ID IC

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 Symbol of the US Federal Communications Commission (FCC) Device license number from the Federal Communications Commission (FCC) Device license number from Industry Canada

Overview • 73

Text/symbol

x-y V max. xxx mA use compatible seca adapter only

Meaning Rating plate on the power supply connection socket • x-y V: required supply voltage • max xxx mA: maximum current consumption • •

: note polarity of device plug : operate device with direct current

Do not dispose of device with household waste

3.4 Marking 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. moisture for transport and storage Not sterile Do not reuse Open packaging here Packaging material can be disposed of through recycling programs

74 •

English

3.5 Menu structure Other functions are available to you in the menu for the device. This enables you to configure the device perfectly to suit your needs (details from page 95). ࠮ Channel 1 (C1) rF*

Learn Autosend

AClear

Send

Group (ID)

࠮ Channel 2 (C2)

࠮ On

࠮ Channel 3 (C3)

࠮ Off

࠮ Off ࠮ On ࠮ Off

࠮ MA ࠮ HI_MA ࠮ Off ࠮ Year ࠮ Month

Time

࠮ Day ࠮ Hour

Reset

Reg. Devices (MO)

࠮ On

࠮ HI Autoprint

Stop

*seca 360° wireless network:

Group (ID) Max. three seca wireless groups: 0, 1, 2 Maximum configuration per wireless group - 1 baby scale - 1 personal scale - 1 length measuring rod - 1 wireless printer - 1 PC with USB wireless adapter

࠮ Minute Sto 1 (Weight) Sto 2 (Weight)

PT

Channel (C1, C2, C3) Net Weight

Sto 3 (Weight)

Autohold

Beep

࠮ On ࠮ Off Press

Hold

࠮ On ࠮ Off

࠮ On ࠮ Off

Example configuration - Group 0: C1 0, C2 30, C3 60 - Group 1: C1 10, C2 40, C3 70 - Group 2: C1 20, C2 50, C3 80

(Note: no spaces in display)

࠮0 FIL

- Three channels per wireless group (total 9 channels) - Channel numbers: 0 - 99 - Only use each channel number once - Recommended spacing: 30

࠮1

Registered devices (MO)

࠮2

Navigation: Navigation: Call up menu:

Menü aufrufen:

tare

- 1: Personal scale - 2: Length measuring rod - 3: Wireless printer - 4: PC with USB wireless adapter - 7: Baby scale

Overview • 75

4. BEFORE YOU REALLY GET STARTED… 4.1 Scope of delivery Components D

E F B G A USA/Japan Euro

Australia UK

C H No. A B C D E F G H

76 •

Component Rear handrail support with display head Right-hand railing support with opening for power pack connection Weighing platform Handrail Caster bar Side bar with opening for power pack connection Display bracket Power pack with adapters (depending on model: Euro connector power pack) Instructions for use, not shown

Pcs. 1 1 1 1 1 1 1 1 1

English

Connecting elements a

d

b e c

No. a b c d e f

f

Component Hex socket head screw M 5 x 12 Pan-head tapping screw 6.3 x 38 Raised countersunk head screw M 6 x 40 Hex socket head screw M 6 x 50 Pan-head tapping screw 2.9 x 9.5 Pan-head tapping screw 3.5 x 9.5 Allen key, 4 mm, not shown Phillips screwdriver size 1, not shown Phillips screwdriver size 3, not shown

Pcs. 6 1 2 1 3 16 1 1 1

Before you really get started… • 77

4.2 Assembling the device We recommend that two people assemble the scale, as large individual parts have to be aligned and then screwed together.

Preparing the weighing platform

Power pack connection

Front

Corner for access

Assembly bores for rear handrail support Assembly bores for righthand handrail support

Rear

1. Place the weighing platform on a flat, stable surface. 2. Align the weighing platform as shown in the diagram above. The weighing platform is in the correct position for fitting the handrail supports as shown in the following sections.

78 •