HS112-C1 12 channel ECG device

Organization name

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság

SRN

HU-MF-000017747

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW017

  HS112 C-1 is a safety class I ECG device with type CF patient isolation and defibrillator protection. The mains cable of the device can be connected to a grounded power outlet only.
• CW133

  In the interest of protecting the environment, please adhere to the following: When replacing the battery, the used or damaged battery should be disposed of only at a designated place for the collection of hazardous waste (NiMH batteries). Disassembly or repair of the device is allowed only to experts trained by the manufacturer.
• CW138

  If the mains power outlet is damaged or not working, or the grounding is inadequate, the device may only be operated using the built-in battery! When connecting the device to a measuring system, make sure that only appropriately isolated and IEC 60601 compliant devices are connected, and that the patient does not come into contact with any devices connected to the mains power supply. If the device is used connected to a computer, make sure that the patient is kept at an at least 1.5 m distance from the computer, or that the computer is operated from an isolation transformer. In case of hot environmental temperatures, the electrodes should be 41°C max when they are placed on the patient.
• CW010

  The use of paper recommended by the manufacturer is advised, as only this ensures the printer head lifetime indicated in the technical specifications. The ECG evaluation program suggests a suitable diagnosis. The final decision is the physician’s responsibility!
• CW276

  At most 10 electrodes may be connected to the patient. The use of separate grounding is FORBIDDEN! Make sure that the unused electrodes (including the N electrode) do not come in contact with any current- carrying objects. Only the type of fuse specified in the documentation is allowed to be used in the device. The defibrillator protection of the device is guaranteed only with one of the following defibrillator protected cables approved by the manufacturer. Cable type: KPACDR and KPACDL
• CW049

  Do not use the device in the presence of combustible, potentially explosive gases.

Primary placement in Hungary; available across 12 countries total.

Trade name

HS112-C1 12 channel ECG device

UDI-DI code

D-HS112-C13P

Basic UDI-DI

B-HS112-C13P

Reference / catalog number

KHS112C1

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.innomed.hu/en/#contact

Clinical sizes

• In amplitude direction: 8 points / mm; On the time axis: 8 or 16 points / mm
• 40 mm, overlap allowed
• 5, 25, 50 mm/s
• 112 mm +0 -1 mm
• 300 pages, 150 mm long pages
• automatic feed
• Sound signal when out of paper
• Date, time, patient identifier code, age, speed, sensitivity, lead marks, filter status
• Amplitude and time parameters measured on averaged QRS cycle, heart frequency, axis positions and Q-T, P-Q, QRS width and diagnostic categories The calculated time parameters are signed by markers on the average curves
• USB
• - online monitoring of 12 leads; -ECG device control from PC; -record creation and storage directly on the PC
• 295 MU50
• 225 MU50
• 80 MU50
• 1.9 MU29
• min. 100 dB
• 50-60 Hz
• 2A@110VAC; 1 A@230VAC
• min. 20 MOhm
• min. +/- 320 mV DC
• max. 700mV/2ms
• min. 2 mV/0,5 ms max. 700mV/2ms
• under 0,3 Hz: complete suppression; over 0,9 Hz: complete transfer
• Audio and visual signal in case of input level error and noisy signal
• Defibrillator protected 10-lead cable
• 4-lead cable
• max. 360 J, 5000 V - Only with defibrillator protected cable!
• 2.5, 5, 10, 20 mm/mV Auto
• 30 – 300 BPM
• +/-1 BPM or +/-2%
• max. 20 µVpp
• 2600 mAh only Innomed produced battery is useable
• In case of totally dead battery max. 2 hours
• Battery nominal voltage — 9.6 MU114
• 0,05 Hz…150 Hz +0,-3 dB
• Intelligent quick charger, thermal protection at 54 °C, thermal fuse at 72 °C
• 60 minutes of ECG curve printing in intermittent operating mode, or 8 hours of monitoring (only basic functions are operated)
• +/- 10 mV
• +/- 3%
• 110-230 VAC
• 8000 Hz / channel
• 24 bit, 0.076µV/bit
• +/-700 mV
• 500 Hz 10 µV/bit
• 500 Hz 5 µV/bit
• PDF
• 1 mV / 300 ms
• min. 3,2 sec
• max. 10 µA
• by channels
• 50 Hz filter: 48,5 … 51,5 Hz; 60 Hz filter: 59 … 61 Hz
• 12-lead, simultaneous (within 100µs)
• 35 Hz +0/-3 dB
• 50 / 60 Hz
• TFT colour, LCD touch screen, size: 5,7”
• 640 x 480 points
• 3 channels + with rhythm lead group change; 6 channels + with rhythm lead group change; 12 (2 x 6) channels + rhythm

• Z12050302ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification