M3 Vital Signs Monitor User Manual Intended Use and Safety Guidance
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WARNING
11 Do not solder the leading wire and the battery terminal directly.
12 Make sure the monitor is used in the appointed range of voltage so that the effect of
power supply can be ignored.
13 Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards. Furthermore all configurations shall
comply with the valid version of the system standard IEC/EN60601-1. Everybody
who connects additional equipment to the signal input connector or signal output
connector configures a medical system, and is therefore responsible that the system
complies with the requirements of the valid version of the system standard
IEC/EN60601-1. If in doubt, consult our technical service department or your local
distributor.
14 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
15 If liquid leaking from the battery gets into your eyes, onto your skin or clothes, do not
rub your eyes. Wash them well with clean water and go to see a doctor immediately.
16 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
17 Do not use a battery with serious scratch or deformation.
18 Only patient cable and other accessories supplied by EDAN can be used. The
performance and electric shock protection cannot be guaranteed, and the patient
may be injured otherwise. Prior to use, check if the casing of a disposable or
sterilized accessory is intact. Do not use it if its casing is damaged.
19 The user should check the monitor and accessories before use.
20 Please set the alarm according to the individual status of patient to avoid delaying
treatment. Ensure there will be alarm audio prompt when alarming.
21 Devices connecting with monitor should be equipotential.
22 The monitor is equipped with a wireless AP/Wi-Fi via network interface to receive RF
electromagnetic energy. Therefore, any other equipment complies with CISPR
radiation requirements may also interfere with the wireless communication and make
it interrupted.
23 Please disinfect timely to prevent cross infection between patients.
24 When the monitor and electrosurgical device are used together, the user (physician
or nurse) should guarantee the safety of patient.
25 This monitor is not a device for treatment purposes.
26 Do not touch the patient, bed or instrument during defibrillation.
27 Do not service or maintain the monitor or any accessory which is in use with the patient.
28 During monitoring, if the power supply is off and there is no battery for standby, the
monitor will be off. All last settings used will be recovered when the power is restored.