Double chamber, Shear Valve Technology for high accuracy, 20 parameters, 60 sample per hour
1.1 Intended Use
The Medonic M-Series is a fully automatic hematology analyzer intended for in vitro diagnostic testing of human blood samples under laboratory conditions.
Operator must have basic laboratory skills and be aware of good laboratory practice.
- Service must be performed by Boule Medical AB (hereafter referred to as Boule), CDS or by service personnel authorized by Boule.
- Use only original spare parts and Boule authorized reagents, controls, calibrators and cleaners. (If these products are substituted it may void your warranty)
- Operators and laboratory supervisors are responsible that Boule products are operated and maintained according to the procedures described in manuals, control inserts and technical bulletins.
Warranty limitations in depth
- Each Boule system is tested using recommended reagents, controls, calibrators and cleaners. All performance claims are generated as part of this complete system.
- Boule products do NOT make diagnoses on patients. Boule intends its diagnostic products (systems, software and hardware) to be used to collect data reflecting the patient’s hematological status. This data, in conjunction with other diagnostic information and the evaluation of the patient’s condition, can be used by a trained clinician to establish a patient’s diagnosis and to define clinical treatment.
1.2 Safety Instruction
Boule incorporates safety features within the instrument in order to protect the operator from injury, the instrument from damage and the test results from inaccuracies.
In order to insure the safety of the operator and instrument follow the instruction below:
- Do not use the instrument outdoors.
- Do no modify the instrument.
- Do not remove the cover
- Do not use the instrument for other purposes than described in this manual.
- Do not spill blood or other fluids on the instrument in such a way that it can leak through the instrument casing. (This might result in electrical malfunction or personal injury)
- Do not drop or place objects on the analyzer.
- Do not use this device in close proximity to source of strong electromagnetic radiation (e.g. unshielded international RF sources), as these can interfere with the proper operation.
- Do not use power supply other than supplied by your local distributor.
- Unauthorized modification of the instrument might result in erroneous results or risk for electrical shock.
- Spilling fluids into the instrument might cause electrical malfunction and/or personal injury.
Handling of reagents
- If a reagent comes in contact with eyes, rinse with running water for several minutes. If symptoms occur seek medical attention.
- If the reagent comes into contact with skin, wash affected area with water
- If swallowed, rinse out mouth. If persistent symptoms occur seek medical attention.
- SDS Sheets are available for all reagents
As there are no assurances of the absence of HIV, Hepatitis B or C viruses or other infectious agents in blood samples, controls, calibrators and waste these products should be handled as potentially biohazardous.
- Protection of Laboratory Workers From Infectious Disease Transmitted by occupationally acquired infections – 2 nd Edition, Approved Guidelines (2001) Document M29-T2 promulgated by the Clinical and Laboratory Standards Institute, CLSI (NCCLS).
- Follow local regulatory documentation.
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