Recommended Safety Checks - Primedic DefiMonitor XD Series Operating Manual

Operating Manual
A6
74

Recommended Safety Checks

According to the Medical Devices Operator Ordinance (MPBetreibV) § 6 (Safety
Checks), the user is required to undertake regular checks. By the Medical Devices
Operator Ordinance (MPBetreibV) § 6, METRAX prescribes these checks every 24
months in the FRG, this is only recommended in other countries.
These safety checks must be assigned to only those persons, who by virtue of their
training, their knowledge and their experience gained from practice, can carry out
these checks correctly and independently.
If the safety-related checks show any defects that can harm the patients, operators or
any other person, then according to the Medical Devices Operator Ordinance (MPBe-
treibV) § 3, the person carrying on the checks must inform the relevant authorities
immediately.
The following information must be entered in the medical device book required to
maintained under the Medical Devices Operator Ordinance (MPBetreibV) § 7:
– time of the tasks
– name of the person and / or company carrying out the tasks and
– the measures carried out.
METRAX is responsible for the data given in the operating manual only. This applies
especially to any new settings, repairs and changes to the device.
During the regular checks, the service technician must carry out the following tasks
and tests:
1. Check the device for any external damage
– Is the casing intact?
– Are the SavePads intact? Check the expiry date!
– Are the SavePads – Input socket and contact plugs intact?
– Is the type plate on the rear of the device and the back side of the power
supply unit readable?
2. Examine the device for any damaged operating elements.
– Is the key pad readable and intact?
– Are the buttons intact and functioning?
3. A check of the electrical fuse must occur under operating conditions. A measure of
the deviated and patient auxiliary currents corresponding to IEC 601-1.
Select the standard deviation and measurements for the CF type.
4. Check the display elements
– Are all the LEDs active for about two seconds after the defibrillator is
switched on?
– Does the warning buzzer sound for about two seconds after the defibrillator
is switched on?
5. Measure the charging time
6. Measure the output
While checking the defibrillation energy, a deviation of ± 15 % at 50 Ω is allowed.
7. Function of the ECG monitor.
– Are all the parameters displayed in the monitor?
Feed an ECG signal with known frequency from an ECG simulator (Defi-Tester)
through a service cable.
DefiMonitor XD
21324 / 09.05 / 02 / GB