If the ALARM SYSTEM is additionally
provided with other sets of auditory ALARM SIGNALS:
[List elements c) to f)]
ü The MANUFACTURER can provide more than one set of auditory ALARM SIGNALS.
M VALIDATION by USABILITY testing is not required if each set complies with Table 3 and Table 4 (or Annex F).
המטרה של
הבדיקות היא
למצוא את
הבלתי צפוי.
עובדה שמחקרים
חדשים מוצאים
בעיות חדשות.
ü
If additional
non-standard auditory ALARM SIGNAL sets (i.e., those that do not comply with
Table 3 and Table 4 or Annex F) are provided, they require clinical VALIDATION to
ensure that they provide at least an equivalent degree of safety as the
standard sounds.
?
Permission to
provide non-standard sounds is intended to allow a RESPONSIBLE ORGANIZATION to
continue to use non-standard but “historically validated” sound sets that have
been successfully used for significant periods of time in their PATIENT care
areas, and to ensure that this collateral standard is not excessively design
restrictive. For example, the RESPONSIBLE ORGANIZATION might prefer some
ventilators in their ICU to make one ALARM SIGNAL sound and ventilators of
another type to make a different sound.
בעקרון,
בארגון עם
נסיון, יש להם
כנראה
תרגולות
טובות
ונכונות, אבל
מצד שני יתכן שהם
נעולים על
פתרונות
מיושנים, שהם
פחות בטוחים.
בנוסף, קרוב
לוודאי
שמקבלי
ההחלטות
בארגון אינם
מודעים
לסיכונים של
אופני הפעולה
השונים בכל
הסיטואציות
האפשריות.
תכלעס, האם אנחנו
יכולים בעזרת
דוגמאות
להמליץ לארגון
מתי לעבור
מתרגולת שהיא מוכחת
בתוך הארגון לתרגולת
שהתגבשה
בוועדת תקינה?
ü
Finally, this
flexible approach should ensure that this collateral standard is not
excessively design restrictive and that future development of improved auditory
ALARM SIGNALS is not hindered.
והנה ההודאה
בצורך לבצע
בדיקות
שימושיות
לפני שחרור
המוצר
ü When choosing an auditory ALARM SIGNAL set, a RESPONSIBLE ORGANIZATION should check that other devices in the PATIENT care area (e.g., pagers, mobile phones) do not generate sounds that could be confused with the medical auditory ALARM SIGNALS of that set unless their meaning is the same.
אולי זה
מסביר מדוע
כשאחי היה
מאושפז
בסקוטלנד הם הקפידו
על כך שכל
הסלולרים
יהיו כבויים.
למה אין הפקדה
כזו בארץ?
אולי זה לא
חשוב? אולי יש
סיבות נוספות?
ü Every effort should be made in designing equipment to integrate ALARM SYSTEMS into a coordinated system, minimizing the total number of ALARM SIGNALS to which an OPERATOR needs to respond. This is important as multiple ALARM CONDITIONS can generate ALARM SIGNALS when one problem occurs.
מדהים שדרישה
כל כך מרכזית,
שיש לה השלכות
על הארכיטקטורה
של מערכת
ההתרעות,
מוצנעת בטקסט,
שבקושי ניתן להבחין
בה. זוהי בעיית
עריכה לכל
אורך המסמך:
צריך לקרוא
אותו שלש
פעמים על מנת
למצוא את העיקר.
ü Sounds from non-medical devices, such as pagers and telephones can resemble medical ALARM SYSTEM auditory ALARM SIGNALS. Care needs to be taken when designing auditory ALARM SIGNALS that the spectral content and amplitude of the ALARM SIGNALS facilitate the localization and identification of the source of the ALARM SIGNAL, taking into account the usual environmental conditions in which the equipment is intended to be used. (See also Annex D.)
אותו טיעון
הובא קודם
כדרישה ללקוח,
וכאן הוא מובא
כדרישה ליצרן.
מה שמחזק את
הצורך בפיצול
הטקסט לשני
חלקים נפרדים.
ü
NOTE 1 When auditory ALARM SIGNALS are provided, this
collateral standard requires that one set of auditory ALARM SIGNALS be encoded
to convey the level of urgency of OPERATOR response required. In addition,
other sets of auditory ALARM SIGNALS have been devised based on categorization
of the nature of the response or awareness and the level of urgency of response
required. [18]
גם זו
דרישה מרכזית
המופיעה
כהערה, ככל
ההערות
ü A USABILITY test differs significantly from a clinical trial, but is equally important in producing usable, safe equipment.
ü This test spotlights the OPERATOR interface and reactions of the OPERATOR to it.
ü A USABILITY test can take up to a week per use model, depending on the number of OPERATORS involved.
חשוב יותר
להגדיר קודם
מה בודקים,
כלומר, באילו
תרחישים, האם
וכיצד המערכת
אמורה להשמע.
תוכן זה יקבע
גם את עלות
הבדיקות.
ü
Such tests can be
conducted in an office-like setting, away from the medical practice
environment.
כמובן שבמעבדה
קשה לדמות את
המציאות.
הבדיקות במעבדה
הן פשטניות,
והמציאות היא
מורכבת (דוגמא
פשוטה –
חילופי משמרת).
ü
This eliminates
interference that would occur in the actual-use environment.
M While USABILITY test formats vary, typically one individual at a time performs
self-exploration as well as directed tasks with the equipment.
זוהי בדיוק
דוגמא לא טובה
של בדיקות
מעבדה, מכיוון
שבדיקה עצמית
היא נטולת לחץ
הזמן
האופייני לחירום.
ü Test administrators can provide special prompts and feedback as required to add realism.
ü As the OPERATOR performs tasks with the equipment, researchers observe and record results.
û
The PROCESS gives
the OPERATOR time to concentrate on using the equipment. An OPERATOR can spend weeks
learning to use the equipment. Whether they encounter operating difficulties or
causes for dissatisfaction over this time depends largely on how much they use
the equipment and which tasks they perform. A USABILITY test compresses the
initial use experience into a shorter time frame, usually 1 h to 4 h.
לא רלבנטי
למערכת
שמיועדת
להשפיע בתנאי
לחץ זמן
û
In hunting for USABILITY
problems, researchers ask OPERATORS to talk their way through each task,
describing what they are thinking, decisions they are contemplating, irritants,
advantages, and so on. Sometimes USABILITY problems surface immediately, such
as when an OPERATOR tries to turn on the equipment and cannot find the power
switch. In such a case the OPERATOR can say:
Now, I'll turn the power on. I am looking at the
front panel but nothing jumps out at me. I see a
switch labelled "standby," but I don't
think that turns it on. You probably press that button
to save power without turning it off. I'm reaching around
the back for a switch, but I don't feel anything. I would expect to find a switch right here [OPERATOR points to
lower right side of control panel]. This green light
probably illuminates when you turn the power on. Oh, I see [OPERATOR presses the
light]. This light is the switch. You press it in to turn the power on. That
wasn't obvious to me.
ü
USABILITY test protocols should include frequent USE SCENARIOS and critical USE SCENARIOS. The effect of stress on how an OPERATOR uses the equipment can be studied by
introducing time limits, removing equipment labelling, or the OPERATOR’S manual, and introducing equipment
failures. Researchers can create a worst-case scenario and see how OPERATORS react. Test outcomes can be compared across
several OPERATORS.
MANUFACTURERS performing such tests commonly find that researchers collect a large
set of USABILITY problems that may have escaped detection during a clinical trial,
since such trials do not explicitly address USABILITY. [25]
עוד דוגמא
לכך שהפיסקא
החשובה ביותר
מופיעה בסוף,
עדות נוספת
לצורך
בשינויי
עריכה.
ü
NOTE 2 Attention is drawn
to IEC 60601-1-6.
