Operating Manual Resting and Stress ECG...Operating Manual Resting and Stress ECG Part 2: Hardware, description of device for custo cardio 400 BT 1 Safety 2 Hardware 3 Software 4 Hygiene

Operating Manual

Resting and Stress ECG

Part 2: Hardware, description of device for custo cardio 400 BT

1 2 3 4Safety Hardware Software Hygiene

Operating characteristics:12-channel PC ECG,Resting & stress ECG

MHW 0012 – DK 1713Version 003 – 06/08/2019

MHW 0012 – DK 1713 | Version 003 – 06.08.2019 | custo med GmbH [2] Resting and Stress ECG Hardware, custo cardio 400 BT | page 2

© 2019 custo med GmbHThis Operating Manual may not be copied in its entirety or in part, duplicated in any form or by any means or translated into another language without the prior written consent of custo med GmbH.

The manufacturer reserves the right to change the information in this Operating Manual without prior notice. The current version can be downloaded from our web-site: www.customed.de.

CAUTION: This Operating Manual is part of a modular system, consisting of four parts. All four parts must be downloaded from the Internet or from a CD to ensure the Operating Manual is complete.

MHW 0012 – DK 1713 | Version 003 – 06.08.2019 | custo med GmbH [2] Resting and Stress ECG Hardware, custo cardio 400 BT | page 3

Table of contents

2.1 Symbols on the devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42.2 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52.3 Part names, components for the recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62.4 Assembly and device operation 2.4.1 Setting the telescope boom and mounting it on the device trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 2.4.2 Placing the device in the telescope boom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 2.4.3 Preparing patient leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 2.4.4 custo cardio 400 BT – device operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102.5 Examination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122.6 Attaching the device to the patient 2.6.1 Electrode application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 2.6.2 Instructions for the stress ECG with treadmill . . . . . . . . . . . . . . . . . . . . . . . . . . . .142.7 Technical data and system requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152.8 Manufacturer's declaration regarding EMC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82.9 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212.10 List of product components and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Operating Manual

Resting and Stress ECG

Part 2: Hardware, description of device for custo cardio 400 BT

1 2 3 4Safety Hardware Software Hygiene

MHW 0012 – DK 1713 | Version 003 – 06.08.2019 | custo med GmbH

2Resting and Stress ECGHardware, description of device for custo cardio 400 BT

[2] Resting and Stress ECG Hardware, custo cardio 400 BT | page 4

2.1 Symbols on the devices

Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 85521 Ottobrunn, Germany Production date (YYYY-MM, e.g. 2018-01)

CE mark, notified body

Observe the Operating Manual

Medical electrical equipment classificationaccording to DIN EN 60601-1 (Type CF)

Non-ionising electromagnetic radiation, Device contains a RF transmitter

Separate collection of electrical and electronic equipment,do not dispose with domestic waste

Hygiene seal of the German Society of Hospital Hygiene




2.2 Intended use

custo cardio 400 BT is a 12-channel electrocardiograph with an integrated electrode application system which is used in professional applications as a resting or stress ECG. The electrode application system uses underpressure to attach the electrodes to the body of the patient. The intercardial application is not intended. The terminal lines are R, L and F according to Einthoven and C1 to C6 according to Wilson.

custo cardio 400 BT is perfectly safe for patients with a pacemaker. The ECG record-ing is not affected by pacemaker pulses.

The device must be operated by suitably trained and qualified personnel in medical practices, laboratories, rehab centres and hospitals. In particular, these include doctors and medical-technical personnel. The intended use of this device does not include use in home settings, especially by laypersons.




C3

C2

C1

R

N

max

min

C3

C2

C1

R

N

max

min

2.3 Part names, components for the recording

custo cardio 400 BT with Bluetooth & USB custo cardio 400 BT ECG application system 6 thoracic wall leads (1.20 m) and

4 extremity leads (1.45 m) Electrode “hair”, other versions optional Spacer 2-fold Spacer 3-fold Telescopic boom for custo cardio 400 BT Bracket for telescopic boom Cable hook for electrode leads (not pictured) Bluetooth-USB adapter (Bluetooth 4.0) USB extension cable BT power supply unit for custo cardio 400 BT 1.5 m power cable for power supply unit 3 m USB cable




2.4 Assembly and device operation

2.4.1 Setting the telescope boom and mounting it on the device trolley

Anti-turn device for fixing the boom, in the open position during operation (270° swivel range)

Continuous height adjustment with gas pressure spring Gas pressure spring Extraction lock to extend and pull in the boom arm Bracket for custo cardio 400 BT with safety bar

Put the clamps and in position and secure them with an Allen key (size 5 mm).Mount the clamps straight (aligned) to keep the gas pressure spring fromjamming.

Use the screw set to fix the bracket to the device trolley , place the boomand protective plastic ring in the bracket, set the swivel range of the boom and then fasten the boom in the bracket .

400 mm

160 mm




Push custo cardio 400 BT into the bracket on the boom. To do this, pull the safety bar back and push the device into the bracket until it clicks into place so that the safety bar is moved back to the front.

Operating the telescope boom safelyFollow the instructions below to safely move the device trolley with the telescopic boom:

Fasten the telescope boom: Tighten the anti-turn device .

Set the angle of the boom arm to 90 degrees: Height adjustment : Press the lever and simultaneously move the boom arm into the desired position by moving the end of the boom arm up or down. To NOT pull the device.

Pull the boom arm in completely: extraction lock .

Assembling custo cardio 400 BTAttach the USB cable to the device, pull the arm of the boom out until it reaches the maximum length. Route the USB cable along the boom and fix it using the Velcro fasteners. Important: Only connect the USB cable after the installation of the software to the PC.

custo cardio 400 BT Power supply linefor connection to the power supply unit 1)

1) Note on the power supply: Use only the power supply unit delivered with the device(item number 85037).

2.4.2 Placing the device in the telescope boom




Attach the coding labels to the ends of the patient leads.

The labels “C1 to C6” are glued to the chest wall leads (length: 1.20 m) .

The labels “R, L, F and N” are glued to the longer extremity leads (length: 1.45 m).

Connect the patient leads according to the coding on the device .

Press the electrodes onto the ends of the electrode leads, until you hear a click .

C3 C2 C1 R

2.4.3 Preparing patient leads




On/off button to manually start operations, otherwise automatic software contro

Status display Suction level control

Controls how strongly the electrodes are fixed to the skin of the patient (levels 1 to 6 can be set)

Cleaning button – for manually blowing out the leads. This is otherwise performed automatically by the software.

Prerequisites for the use of the device:Proper installation, configuration and commissioning of the system.

Examples of visual feedback from the device during operation

Standby mode:The on/off button illuminates in blue

Status after calling up the ECG interface in custo diagnostic (or in manual mode by pressing the on/off button):The on/off button and suction level control are illuminated in blue, the status display shows the preset suction level in the colour of the connection type, blue for Bluetooth in this case. The suction level can be adjusted manually by pressing the suction level control button .

Status after ending the ECG recording, when the ECG interface is closed:When ending the ECG recording, the electrodes are released and the leads are blown out. The on/off but-ton and the cleaning button illuminate in blue, and the status display illuminates green for the duration of the blow-out. The green status display becomes smaller according to the progression of the blow-out time (if the entire duration of the blow-out time is less than one minute).

2.4.4 custo cardio 400 BT – device operation

Status display states:

Turquoise LED = USB modeBlue LED = Bluetooth/WLAN modeOrange LED = Manual recordingGreen LED = Blow out of the leadsYellow LED = Warning notification




Recording functions and procedures: Changing the connection type

If a USB connection is available, it is prioritised over the wireless connection because of the higher data rate. The connection can only be changed by the device (e.g. from Bluetooth to USB) if a recording is not currently underway.

Manual starting and ending An ECG recording can also be started by pressing the on/off button instead of using the software interface. To do this, open the ECG interface in custo diagnostic and press the on/off button on the device. The status display illuminates in orange, and the ECG recording proceeds according to the custo diagnostic configu-ration. Recordings without a time limit must be ended by pressing the on/off button again (e.g. rhythm strips).

Automatic suction level controlTo use this function, the suction level must be set to at least level 3 in custo diagnostic. With automatic suction power control, the suction level is increased until the system is airtight and the electrodes rest tightly enough against the skin of the patient. If the suction level is set manually, automatic suction level control is deactivated.

Cleaning the electrode leadsThe cleaning function should be used regularly, e.g. always at the end of a working day. By pressing the cleaning button, the moisture is blown out of the elec-trode leads for a longer period of time. Procedure ac-cording to settings in custo diagnostic, factory setting: 30 minutes. After the cleaning time has elapsed, the device switches to standby mode.

Device warningsIf there is a technical problem, the status display illuminates in yellow. Contact your authorised custo med dealer.

Resetting the Bluetooth connectionAt commissioning or if the device is deployed in mobile applications, the existing Bluetooth connection may need to be reset (e.g. to allow the device to connect to a different work station). To do this press the “+” and

“-” buttons simultaneously for approx. 2 seconds. The device turns off briefly.

Figure: USB connection, status display changes from blue (wireless connection) to turquoise (USB connection)

Figure: Starting a recording manually, status display orange




2.5 Examination procedure

Prerequisites for an examination:Proper installation, configuration and commissioning of the system.

Resting ECG Make sure that the ECG device is connected to the PC

and the power supply of the device is guaranteed. Check that your patient is lying comfortably and is not cold. Start custo diagnostic and click:

Examination, Resting ECG, New Resting ECG see Software description... . Spray the contact spray1) on the electrode application points. Place the electrodes on the patient according to the placement diagram,

See 2.6.1 Electrode application. Start the recording. The patient must keep still during the recording process.

Stress test ECG Make sure that the ECG device is connected to the PC

and the power supply of the device is guaranteed. When using an ergometer, make sure that the patient is in the optimal

seating position (the extended leg should be slightly bent). When using a treadmill, make sure to follow the instructions

in 2.6.2 Instructions for stress ECG with treadmill. Start custo diagnostic and click:

Examination, Stress ECG, New Stress ECG see Software description... . Spray the contact spray 1) on the electrode application points. Place the electrodes on the patient according to the placement diagram,

See 2.6.1 Electrode application. Wait a few minutes so that the contact between the skin

and the electrodes can develop optimally. Apply the blood pressure cuff. Start the recording.

1) Contact spray warningBefore each examination, make sure to spray contact spray on the electrode application points. Never spray the contact spray onto the electrodes or into the electrodes or leads. Do not use water or contact gel!

Recommended contact sprays from: C+V Pharma Depot GmbH or GE Medical Systems

Only use recommended contact sprays. Residues from other products can damage the custo cardio 400 BT electrodes.




2.6 Attaching the device to the patient

2.6.1 Electrode application

Thoracic wall resting and stress ECG, standard according to WilsonV1 (C1) red 4. Intercostal space at the right sternal borderV2 (C2) yellow 4. Intercostal space at the left sternal borderV3 (C3) green on left-hand side of the 5th rib between C2 and C4V4 (C4) brown 5th intercostal space on the left midclavicular lineV5 (C5) black on the left-hand side of the anterior axillary line, at the same height as C4V6 (C6) purple on the left-hand side of the midaxillary line, at the same height as C4

Extremities resting ECGR red right armL yellow left armF green left legN black right leg

Stress ECG (lying or standing): extremitiesR red on the right below the collarboneL yellow on the left below the collarboneF green on the left above the hipN black on the right above the hip

Stress ECG (sitting position): extremitiesR red attach to the deltoid muscle on the rightL yellow attach to the deltoid muscle on the leftF green 9. Left ribN black 9. Right rib




2.6.2 Instructions for stress ECG with treadmill

The patient should ideally be wearing running shoes or trainers. The patient should not hold onto the handles of the treadmill during

the recording process. This will lead to muscle tension which will affect the ECG signal.

Missing skin tension, in interaction with shoulder movement, will increase artefacts in the ECG signal.

The extremity leads should if possible be applied on taut skin areas in order to avoid excessive movement artefacts and therefore interference in the other terminal lines.

During the ECG recording, the electrode leads must not come into contact with the patient, the treadmill or other objects.

Normal electrode application

Artefact reduced electrode application Artefact reduced electrode application results in smaller amplitudes in the extremity leads.

Safe use of treadmills with stress ECGAlways set the treadmill so that the patient can safely move on the device. Ensure that the acceleration, speed and inclination of the treadmill are adjusted to the patient's physical constitution, stamina and skill. Observe the manufacturer's safety instructions.Always inform the patient before you change the acceleration, speed or inclination. Otherwise, the patient may become injured, e.g. also due to an unexpected, abrupt stopping or starting of the treadmill.




2.7 Technical data and system requirements

custo cardio 400 BT

Number of ECG channels 12

Frequency response 0 to 0.262 * sampling frequency [HZ]

Sampling frequency 1000, 2000, 4000, 8000, 16000 (only with USB), 32000 (only with USB) Hz

Sampling rate Identical for all channels, possible settings:

1.0 ms / 0.5 ms / 0.25 ms / 0.125 ms / 0.0625 ms (only with USB) / 0.03125 ms (only with USB)

Deviation < 1.5 %

A/D converter 24 bit

Input impedance > 50 MΩ

Amplitude quantification 1.526 µV/bit

CMRR > 93 dB

Impedance measurement 1) at all electrode leads (not N) with automatic quality indication

Defibrillation protection Electrical strength 5000 V

Recovery time after defibrillation < 5 s

Suction power Level 0 = 0 mbar Level 4 = 180 mbar

Level 1 = 60 mbar Level 5 = 220 mbar

Level 2 = 100 mbar Level 6 = 280 mbar

Level 3 = 140 mbar

Power supply 12 V power supply unit

Maximum power consumption 7 Watt

EDV connection USB (3 m) and Bluetooth 2.1 EDR

Radio frequency band Bluetooth 2.1 EDR: 2.402 – 2.480 GHz (ISM Band)

Radio transmitting power Bluetooth 2.1 EDR: max. 10 dBm

Bluetooth range generally 10 m, depending on ambient conditions

Time to standby mode2) after disconnection from USB 30 min

last BT communication 30 min

last manual configuration 30 min

IP protection class IPX0 (not protected from water permeation)

Dimensions 250 * 110 * 60 mm (L * W * H)

Weight approx. 680 g (device without leads and electrodes)

Patient leads approx. 1450 mm (extremities)

approx. 1200 mm (chest wall)

Operating conditions Temperature +10°C ... +40°C

Air humidity 30 ... 75 % rH

Air pressure 700 ... 1060 hPa

Transport and Temperature -20°C ... +45°C

Storage conditions Air humidity 10 ... 95% rH

Air pressure 700 ... 1060 hPa

Classification Device with external power supply,

Class IIa according to MDD, Type CF application part

Underlying standards DIN EN 60601-1, DIN IEC 60601-2-25; DIN EN 60601-1-2

1) Does not apply to Bluetooth devices.2) The pump and value are deactivated in standby mode. Communication via USB/BT as well as manual configuration of the system are still possible. Standby mode is not activated during an ECG recording.




General system requirements

Operating system Windows 7 SP1 – with current updates

(32 bit and 64 bit operating system)

Windows 8 (32 bit and 64 bit operating system)

Windows 8.1 (32 bit and 64 bit operating system)

Windows 10 (32 bit and 64 bit operating system)

Windows Server 2003 (32 bit and 64 bit operating system)

Windows Server 2008 (32 bit and 64 bit operating system)

Windows Server 2008 R2

Windows Server 2012

Windows Server 2012 R

older versions are not supported

PC The PC hardware should meet the minimum requirements of the

operating system used. Provide additional RAM (1 GB) for

custo diagnostic. Please ensure that there is sufficient free space

on the hard disk for the custo diagnostic evaluations.

The PC must meet the requirements of the safety standard

DIN EN 60950 for information technology equipment.

File sizes of the evaluations Holter: approx. 15 MB (max. 60 MB)

ABPM: approx. 128 KB (max. 512 KB)

Holter-ABPM: approx. 20 MB (max. 25 MB)

Resting ECG: approx. 200 KB (for an ECG of approx. 10 seconds)

Stress ECG: approx. 6 MB (for an ECG of approx. 20 minutes)

CPET: refer to stress ECG

Spirometry: approx. 50 KB (max. 256 KB)

Rehab: approx. 6 MB (for approx. 45 minutes of exercise)

Hardware & ports DVD or CD-ROM drive,

USB port




Recommended system requirements

Computer Intel Core i3-CPU with HD graphics 4400

4 GB RAM

256 GB SSD or SSHD (for single-position systems 2TB HDD)

1 GBit network connection (not for single-position systems)

Fanless Dual-DVI (or DP) graphics card (for CPET)

Windows 8.1 x64 (PRO version for joining a domain)

Ports One USB 2.0 port per USB device (preferably not USB 3.0)

One COM port each for ergometer and treadmills (serial)

At least Version 4.0 if Bluetooth is installed

otherwise can be deactivated in the BIOS

Monitor 20“ TFT with DVI or DP port

Full HD resolution

Dual-TFT for spiroergometry

Printer 600 dpi

Monochrome (colour recommended for spiroergometry)

USB 2.0 port or network connection

PCL-enabled (increases printing speed with the suitable driver)




2.8 Manufacturer's declaration regarding EMC (electromagnetic compatibility) according to DIN EN 60601-1-2:2016

Lead lengthsPatient leads approx. 1450 mm (extremities) approx. 1200 mm (chest wall)USB cable approx. 3000 mm

Manufacturer's declaration – electromagnetic emissionsThe custo cardio 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment.

Manufacturer’s declaration – electromagnetic immunity The custo cardio 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment.

COMMENT: UT is the alternating supply voltage prior to application of test levels

Emission measurements

RF emissions according to CISPR11

RF emissions according to CISPR11

Harmonics according to IEC61000-3-2

Voltage fluctuations/flickers according to IEC61000-3-3

Compliance

Group 1

Class B

Class A

Complies

Immunity tests

Static electricity discharge (ESD) according to IEC 61000-4-2

Quick transient electric interference factors / bursts according to IEC 61000-4-4

Surgesaccording to IEC 61000-4-5

Voltage drops, brief interruptionsand fluctuations in supply voltageaccording to IEC 61000-4-11

Magnetic field at supply frequency (50/60 Hz) according to IEC 61000-4-8

IEC 60601- test level

± 8 kV contact discharge± 15 kV air discharge

± 2 kV for net wires± 1 kV for input and Output leads (SIP/SOP)

± 1 kV lead against lead± 2 kV lead against end

< 5 % UT for 0.5 periods(> 95 % drop)

40 % UT for 5 periods(60 % drop)


< 5 % UT for 5 s(> 95 % drop)

30 A/m

Compliance level

± 8 kV contact discharge± 15 kV air discharge

± 2 kV for net wires± 1 kV for input and Output leads (SIP/SOP)

± 1 kV lead against lead± 2 kV lead against end

< 5 % UT for 0.5 periods(> 95 % drop)



< 5 % UT for 5 s(> 95 % drop)

30 A/m

Electromagnetic environment - guidelines

custo cardio 400 BT uses the 2.4 GHz range frequency band to communicate with the PC. Its level of RF emis-sion is therefore very low and is unlikely to be sufficient to interfere with other electronic devices.

custo cardio 400 BT is suitable for use in all establish-ments, including domestic establishments and those di-rectly connected to the public low voltage power supply network that supplies buildings used for domestic pur-poses.




Manufacturer’s declaration – electromagnetic immunityThe custo cardio 400 BT ECG application system is designed for use in the electromagnetic environment stated below. The customer or user of custo cardio 400 BT should make sure that it is used in such an environment.

1) The ISM bands (EN: Industrial, Scientific and Medical, i.e. frequency bands used for industrial, scientific and medical purposes) between 0.15 MHz and 80 MHz are 6.765 to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz; 3.5 MHz to 4.0 MHz; 5.3 MHz to 5.4 MHz; 7 MHz to 7.3 MHz; 10.1 MHz to 10.15 MHz; 14 MHz to 14.2 MHz; 18.07 MHz to 18.17 MHz; 21 MHz to 21.4 MHz; 24.89 MHz to 24.99 MHz; 28 MHz to 29.7 MHz and 50 MHz to 54.0 MHz.

COMMENT on the tableRow 2: Applies for all other connections (patient leads, power supply unit, USB cable)Row 3: Applies for the custo cardio 400 BT housing

Immunity tests

Conducted disturbances, induced by high-frequency fields

according to IEC61000-4-5

Radio-frequency electromagnetic fields

according to IEC61000-4-3

IEC 60601- test level

3 Veffective value

0.15 MHz to 80 MHz

6 Veffective value

in ISM frequency bands1)

between 0.15 MHZ and 80 MHz

80 % AM at 1 kHz

3 V/m

80 MHz to 2.7 GHz

80 % AM at 1 kHz

Compliance level

3 Veffective value

0.15 MHz to 80 MHz

6 Veffective value

in ISM frequency bands1)

between 0.15 MHZ and 80 MHz

80 % AM at 1 kHz

10 V/m

80 MHz to 2.7 GHz

80 % AM at 1 kHz




Recommended protective distances between portable and mobile RF telecommunication devices and custo cardio 400 BTcusto cardio 400 BT is designed for use in an electromagnetic environment in which the RF transients can be controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the device – depending on the power output of the communication device, as indicated below.

WARNING: Wearable RF communication devices (radio devices) (including their accessories, e.g. antenna cables and external antennas) should not be used at distances of less than 30 CM (12 inches) from the custo cardio 400 BT parts and leads described by the manufacturer. Failure to observe this warning can compromise the per-formance of the device.

WARNING: Use of this device directly next to other devices or stacked together with other devices should be avoided, as this could result in fault operation. If the devices must nonetheless be used as described above, this device and the other devices should be monitored to ensure proper functionality.

a) For some radio services, on the frequencies for the radio connection of mobile communication devices to the base station (uplink) were included in the table.

COMMENT on protection clearances: The minimum clearances for increased immunity test levels must be calculated using the following equation:

where P is the maximum output in Watt (W), d the minimum clearance in metres (m) and E the immunity test level in Volt per metre (V/m).

General COMMENTS: These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people.

Frequency banda) MHz

380 to 390

430 to 470

704 to 787

800 to 960

1700 to 1990

2400 to 2570

5100 to 5800

Radio servicea)

TETRA 400

GMRS 460, FRS 460

LTE Band 13, 17

GSM 800/900,TETRA 800, iDEN 820,

CDMA 850, LTE Band 5

GSM 1800, CDMA 1900,GSM 1900, DECT,

LTE Band 1, 3, 4, 25,UMTS

Bluetooth, WLAN 802.11 b/g/n

RFID 2450, LTE Band 7

WLAN 802.11 a/n

Maximum output in W

1.8

2

0.2

2

2

2

0.2

Clearance in m

0.3

0.3

0.3

0.3

0.3

0.3

0.3

Immunity test level in V/m

27

28

9

28

28

28

9

� � 6d∗ √P




2.9 EC Declaration of Conformity




Set no. Set name Part no. Qty. Set/product designation

85130 custo cardio 400 BT

84024 1 custo cardio 400 BT ECG application system

85034 6 Thoracic wall leads (1.20 m)

85035 4 Extremity leads (1.45 m)

85027 2 Pck.10 Electrode “hair”

85032 2 Spacer 2-fold

85033 2 Spacer 3-fold

85060 1 Telescopic boom for custo cardio 400 BT

with velcro fasteners and hex key

85073 1 Bracket for telescopic boom

85070 1 Cable hook for custo cardio 400 BT

55050 1 Bluetooth 4.0 USB adapter LM506

16018 1 1.8 m USB extension cable connector A – power outlet A

85023 BET-0612 power supply unit for custo cardio 400, 12 V, 5 A

85044 Power supply cable for power supply unit BT, 1 m

85031 1 3 m USB cable for custo cardio 400 BT

2.10 List of product components and accessories

Accessories Part no. Set/product designation

85027/Z Electrode “hair” (bag of 10 pieces)

85064/Z Electrode “standard” (bag of 10 pieces)

85065/Z Electrode “small” (bag of 10 pieces)

85035/z Extremity lead (1.45 m)

85034/z Thoracic wall leads (1.20 m)

85061 Extra long suction lead (1.65 m)

85032 Spacer 2-fold

85033 Spacer 3-fold

85036/z Coding set (1 sheet of 10 pieces)

85070 Cable hook for custo cardio 400 BT

85060 Telescopic boom for custo cardio 400 BT

85081 Telescopic boom for trolley custo easy plus

85073 Bracket for telescopic boom including fixtures

85068 Universal bracket for custo cardio 400 BT

85079 Wall mounting set for custo cardio 400 BT

85037 BET-0612 M power supply unit 12 Volt for custo cardio 400 BT

85038 Black 1.5 m power supply cable for power supply unit BET-0612

85047 Power supply unit VEC50US15, 15 Volt für custo cardio 400

85044 Power supply cable for power supply unit VEC50US15, 1 m

85044-5 Power supply cable for power supply unit VEC50US15, 5 m

85031 3 m USB cable for custo cardio 400 BT

55050 Nano Bluetooth USB adapter

85056 Clamp adapter socket 4 mm f. connection to patient simulator (5 pcs.)

85057 Adapter for patient simulator (10 pcs.)

Manufacturer's contact details:custo med GmbHMaria-Merian-Straße 685521 OttobrunnGermany

Phone: +49 (0) 89 710 98 - 00Fax: +49 (0) 89 710 98 - 10E-mail: [email protected]: www.customed.de

Documents

Operating Manual Resting and Stress ECG...Operating Manual Resting and Stress ECG Part 2: Hardware, description of device for custo cardio 400 BT 1 Safety 2 Hardware 3 Software 4 Hygiene