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  • Info | Technical Specification - CuroCell A4 – Instructions of Use

Info | Technical Specification - CuroCell A4 – Instructions of Use

Learn more about the CuroCell A4 mattress and control unit with the technical specifications listed.

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    Control Unit Specification Mattress Specification Table 1 - Determination of ALARM CONDITIONS and assignment of priorities Potential result of failure to respond to the cause of ALARM CONDITION Onset of potential HARM a Immediate b Prompt c Delayed d

    NB: Care of Sweden reserves the right to modify the product specification at any time.

    Control Unit Specification

    Model   CuroCell® A4
    Input voltage   100‐240 V / 50‐60 Hz
    Power consumption   1.5 A
    Mode of operation   Alternating, Pulsating and CLP (Constant low pressure)
    Duty cycle (Pulsating and Alternating) 10 min, 15 min, 20 min, 25 min
    Power supply Ungrounded AC outlet, electrical safety class II Use only power supply with P/N WR9QE1500LRPCIMG3138
    Dimensions (L x W x H)   11 cm x 30 cm x 20 cm
    Weight   2.9 kg
    Sound level, control unit, max:   EN ISO 11201:2010 -17 dBA (at operator position), 16,5 dBA (at head end). ISO 3746:2010 – 25 dBA.
    Environmental Temperature

    Operation: +5 to 40°C 

    Storage: -25 to 70°C 

    Transport: -25 to 70 °C

      Humidity

    Operation: 15 % – 93 % non‐condensing 

    Storage: < 93 % non‐condensing

      Atmospheric 700 hPa – 1060 hPa
    Electrical classification   Class II, Type BF
    IP classification   IP42
    Degree of safety in presence of inflammable anesthetics:   The device is not intended for use with flammable anaesthetic gases
    Applied part   Mattress

    Mattress Specification

    Model Dimensions (WxLxH) Weight
    CuroCell® OP10 80/85/90 x 200/210 x 10 cm 3,7 kg (80x200 cm)
    CuroCell® CX10 80/85/90/100/105/120 x 200/210 x 10 cm 5,2 kg (80x200 cm)
    CuroCell® CX15 80/85/90/100/105/120 x 200/210 x 15 cm 10,0 kg (80 x 200 cm)
    CuroCell® CX16 80/85/90/100/105/120 x 200/210 x 16 cm 12,0 kg (80x200 cm)
    CuroCell® CX20 80/85/90/100/105/120 x 200/210 x 20 cm 11,0 kg (80x200 cm)

    CuroCell A4/IQ has information signal with LED indicators, on the control panel, and sound (discontinuous) for high/low pressure, power failure, wrong air connections/no mattress installed and for service notification.

    All situations when there is a need for an acoustic- and visible- signal from the control unit is regarded as an information signal.

    See table below for determination of alarm conditions which is specified in the standard IEC 60601-1-8.

    Table 1 - Determination of ALARM CONDITIONS and assignment of priorities

    Potential result of failure

    to respond to the cause

    of ALARM CONDITION

    Onset of potential HARM a

    Immediate b

    Prompt c

    Delayed d

    Death or irreversible injury HIGH PRIORITY ALARM CONDITION e HIGH PRIORITY ALARM CONDITION MEDIUM PRIORITY ALARM CONDITION
    Reversible injury HIGH PRIORITY ALARM CONDITION MEDIUM PRIORITY ALARM CONDITION LOW PRIORITY ALARM CONDITION
    Discomfort or reversible minor injury MEDIUM PRIORITY ALARM CONDITION LOW PRIORITY ALARM CONDITION LOW PRIORITY ALARM CONDITION, no ALARM CONDITION or INFORMATION SIGNAL

    a

    b

    c

    d

    e

     

     

    Onset of potential HARM refers to when an injury occurs and not to when it is manifested.    

    Having the potential for the event to develop within a period of time not usually sufficient for manual corrective action.

    Having the potential for the event to develop within a period of time usually sufficient for manual corrective action.

    Having the potential for the even to develop within an unspecified time greater than that given under “prompt”.

    Where practicable, ME EQUIPMENT with a therapeutic function incorporates automatic safety mechanisms to prevent immediate death or irreversible injury caused by the ME EQUIPMENT. See also appropriate particular standards.

     

    In our risk management process we have determined the potential failure to respond to the cause of alarm condition to be “Discomfort or reversible minor injury” and the potential harm to be “Delayed” which is our rationale for information signal.

    Information signals are not specified or controlled by IEC 60601-1-8.

    In IEC 60601-1 there is only specified an upper level which the signal should not exceed.

    CuroCell A4 is tested and approved according to IEC 60601-1 but there is no clause in that standard specifying a lowest level for an information signal.

    We have chosen a sound level of the acoustic information signal from CuroCell A4 with a distinct difference than signals from other medical devices with High or Medium Alarm conditions.

    This will make it easier for the personnel in the hospitals to tell the difference between an information signal and a signal for high alarm condition.

    Therefore, the sound level can be seen as quiet but it's made with a purpose.

    Learn more about the CuroCell A4 product line, along with other Care of Sweden products by visiting the Crescent Healthcare website, and by reading the articles under the Care of Sweden category.

    specification technical curocell a4 instructions of use

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