Description

Intended Use

General

The ZM-540PA and ZM-541PA transmitter transmits ECG, respiration and pulse waveforms, SpO2

and NIBP data from a patient to a Nihon Kohden monitor for continuous monitoring. The front LCD

displays ECG (or pulse wave), numeric values of monitoring parameters, NIBP measuring mode and

interval, messages and battery condition.* It also displays the compressed waveform and numeric

data of the latest 10 minutes.

GENERAL HANDLING PRECAUTIONS

This device is intended for use only by qualified medical personnel.

Use only Nihon Kohden approved products with this device. Use of non-approved

products or in a non-approved manner may affect the performance specifications

of the device. This includes, but is not limited to, batteries, recording paper, pens,

extension cables, electrode leads, input boxes and AC power.

Please read these precautions thoroughly before attempting to operate the instrument.

1.   To safely and effectively use the instrument, its operation must be fully understood.

2.   When installing or storing the instrument, take the following precautions:

(1)  Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and

temperatures, poorly ventilated areas, and dust, saline or sulphuric air.

(2)  Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even

during transport.

(3)  Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.

(4)  The power line source to be applied to the instrument must correspond in frequency and

voltage to product specifications, and have sufficient current capacity.

(5)  Choose a room where a proper grounding facility is available.

3.   Before Operation

(1)  Check that the instrument is in perfect operating order.

(2)  Check that the instrument is grounded properly.

(3)  Check that all cords are connected properly.

(4)  Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems.

(5)  All circuitry used for direct patient connection must be doubly checked.

(6)  Check that battery level is acceptable and battery condition is good when using battery operated models.

4.   During Operation

(1)  Both the instrument and the patient must receive continual, careful attention.

(2)  Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.

(3)  Avoid direct contact between the instrument housing and the patient.

5.   To Shut down After Use

(1)  Turn power off with all controls returned to their original positions.

(2)  Remove the cords gently; do not use force to remove them.

(3)  Clean the instrument together with all accessories for their next use.

6.   The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order.

7.   The instrument must not be altered or modified in any way.

8.   Maintenance and Inspection

(1)  The instrument and parts must undergo regular maintenance inspection at least every 6 months.

(2)  If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.

(3)  Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden representative.

9.   When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient.

10.  When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.