Water Temperature Increasing Temperature Silence Alarm Risk of E xplosion: Do not use in the Presence of Flammable Anesthetics Disconnect Power Before Servicing Change Water Quarterly Temp. Set Point Indicator Decreasing Temperature Caution: Read Operation Instructions and Manual Before Operating Patient Temperature Automatic Control Manual Control Temperature Set Stop - Repair Equipotential Ground Power Cord Holder Water Flow Indicator Fill to Strainer Danger; Risk of Electric Shock Outlet Inlet Test Indicators Clean Water Filter Quarterly Clean Condenser Quarterly Monitor Only ESD Susceptibility Type B Equipment Separate collection for electrical and electronic equipment AC Voltage.

• Blanketrol Ii Model 222 Service Manual

Therapeutic hypothermia improves the survival and neurodevelopmental outcome of infants with newborn encephalopathy of a hypoxic-ischemic origin. The NICHD Neonatal Research Network (NRN) Whole Body Cooling trial used the Cincinnati Sub-Zero Blanketrol II to achieve therapeutic hypothermia. The Blanketrol III is now available and provides additional cooling modes that may result in better temperature control.

Patient Temperature Management Accessories that support. Is a water temperature. And water flow functions of the Electri-Cool® II and. BLANKETROL@ II. OPERATION MANUAL. The operator must read and understand the. Operation Manual in its entirety prior to operating the equipment.

This report is a retrospective comparison of infants undergoing hypothermia using two different cooling modes of the Blanketrol device. Infants from the NRN trial were cooled with the Blanketrol II using the Automatic control mode (B2 cohort) and were compared with infants from two new NRN centers that adopted the NRN protocol and used the Blanketrol III in a gradient mode (B3 cohort). The primary outcome was the percent time the esophageal temperature stayed between 33°C and 34°C (target 33.5°C) during maintenance of hypothermia. Cohorts had similar birth weight, gestational age, and level of encephalopathy at the initiation of therapy.

Baseline esophageal temperature differed between groups (36.6°C±1.0°C for B2 vs. 33.9°C±1.2°C for B3, p. Introduction E ncephalopathy in late preterm and term newborns is a serious condition stemming from multiple different etiologies and can be associated with a poor outcome including cerebral palsy, neurodevelopmental impairments, and neurosensory deficits when assessed as late as 30 months (Miller et al.,; Pierrat et al., ). In the subset of newborn encephalopathy attributed to hypoxia–ischemia, outcome has been tracked over longer intervals and poor outcomes persist even at school age (Robertson et al., ). The clinical management of hypoxic-ischemic encephalopathy has traditionally been limited to intensive supportive care whereby organ system dysfunction was supported, biochemical abnormalities were corrected, and seizures were treated when present. Over recent years management has changed with the demonstration of benefit associated with therapeutic hypothermia among multiple clinical trials.

Meta-analysis of eight randomized clinical trials involving 1344 participants indicate that therapeutic hypothermia initiated at less than 6 hours of age in newborns with moderate or severe encephalopathy is associated with a reduction in death or major disability at 18 months of age (relative risk 0.75, 95% confidence intervals, 0.68, 0.83) (Jacobs et al., ). Therapeutic hypothermia is being disseminated throughout the neonatal community with more widespread penetration in some countries compared to others (Azzopardi et al.,; Iwata et al., ). Both head and body cooling are used, both are effective and there are no clear data that one mode of cooling is superior to the other. Irrespective of the mode of cooling, temperature control is important. Wide fluctuations in temperature above and below a target temperature may limit the effectiveness of therapeutic hypothermia; elevated temperatures may provide less neuroprotection and lower temperatures may pose a greater risk of adverse events. A number of different commercial devices are available for providing therapeutic hypothermia. In the National Institute of Child Health and Development (NICHD) Neonatal Research Network (NRN) whole body cooling trial, the Blanketrol II (Cincinnati Sub-Zero CSZ, Cincinnati, OH) was used in the Automatic Control mode and the esophageal temperature was the site controlled (Shankaran et al., ).

Unexpectedly, decreases in esophageal temperature of more than 1.5°C below the target temperature of 33.5°C occurred in some infants. These observations prompted a detailed review of the temperature profile of infants undergoing body cooling (Shankaran et al., ). During the maintenance phase, 10 of 101 infants had esophageal temperatures of. Methods This is a retrospective comparison of two cohorts of infants undergoing therapeutic hypothermia with different modes of cooling using the CSZ Blanketrol device. One cohort ( n=101) included infants undergoing hypothermia from the NICHD whole body cooling trial, enrolled between 2000 and 2003, and cooled using the automatic control mode of the Blanketrol II (B2 cohort) (Shankaran et al., ). The second cohort ( n=110) consisted of infants born between 2008 and 2010 and provided whole body cooling at Children's Mercy Hospital (Kansas City, MO, n=57) and Nationwide Children's Hospital (Columbus, OH, n=53) using the Gradient 10C mode or the Gradient Variable mode of the Blanketrol III (B3 cohort). These two centers adopted and implemented the NICHD hypothermia regimen including eligibility criteria, use of the Blanketrol device, and frequency of recording temperatures.

Both cohorts had temperature probes positioned in the lower third of the esophagus and an esophageal temperature (Tes) of 33.5°C was the target temperature. The Blanketrol device functions as follows: in the Automatic Control mode the Tes is compared to the target temperature by the unit's microprocessor; if the infant's Tes is lower than the target temperature, the device heats the circulating water to the highest allowable water temperature (42°C) to elevate the infant's Tes.

If the infant's Tes exceeds the target temperature, the device cools the circulating water to the lowest allowable water temperature (4°C) until the Tes is decreased to the target temperature. When the Tes reaches the target temperature the unit continues to circulate the water without heating or cooling. If the Tes falls below or increases above the target temperature, the device resumes heating or cooling, respectively. In the NICHD randomized trial, the Automatic Control mode was used with two blankets attached to the device; one for the infant to lie on (25×33-inches) and a larger blanket (25×64-inches) suspended nearby. Preliminary work using newborn piglets performed prior to the NICHD whole body cooling trial indicated that circulating water through two blankets simultaneously reduced the magnitude of the swings in temperature above and below the target temperature compared to using a single blanket (Shankaran et al., ).

In the Gradient 10C mode the device monitors the infant's Tes and limits the maximum difference between the circulating water temperature and Tes to 10°C above or below the Tes; this is designed to minimize the swings in Tes, which may occur if the circulating water temperature is changing by large increments. Similar to the Automatic Control mode, when the Tes reaches the target temperature the unit continues to circulate the water without heating or cooling, respectively. The Gradient Variable mode functions similarly to the Gradient 10C mode except that the user inputs a specific gradient offset value for the difference between the water temperature and Tes. This provides flexibility in determining the extent of difference in the water temperature and Tes. The Gradient 10C and Gradient Variable modes were used with a single blanket (25×33-inches) positioned under the infant. Demographic information included birth weight and gestational age.

Inclusion in the analyses of these studies required documentation of moderate or severe encephalopathy since this was a criteria of the NICHD whole body cooling trial (Shankaran et al., ). Comparisons between cohorts were performed for baseline data and temperatures during induction and maintenance of hypothermia. Baseline represents assessments when the infant was placed on the blanket. The induction period was defined as following initial placement of the infant on the cooling blanket and continued through the initial overshoot below the target temperature ending when Tes returned to within 0.1°C of 33.5°C, the target temperature. The maintenance period extended from completion of induction until the initiation of rewarming after 72 hours of hypothermia. The primary outcome was the percent time Tes was in the target range (33°C–34°C). Cohorts were compared using mean and standard deviations, 95% confidence intervals of the mean, median, and interquartile ranges.

Mean values during maintenance were determined using a longitudinal, repeated measures regression model. Similar modeling was used to compare the temperature gradient between Tes and the blanket water. The proportion of infants with Tes above 34°C and below 33°C was compared with a Fisher's exact test. A secondary outcome was the temperature achieved during induction of hypothermia. Results In the B2 cohort, there were 102 infants randomized to hypothermia but one infant did not receive the intervention. Of the remaining 101 infants, 1 met inclusion criteria due to seizures and a neurological examination was not performed on this infant.

Thus, 100 infants assessed to be moderate or severely encephalopathic constituted the B2 cohort. In the B3 cohort, 110 patients were eligible but 20 were excluded due to missing neurologic exams ( n=6) or presence of mild encephalopathy ( n=14). Ninety infants with moderate or severe encephalopathy made up the B3 cohort. Infant characteristics along with baseline data at the initiation of cooling are listed in. Infants in the two cohorts were similar in birth weight, gestational age, Apgar scores at 5 and 10 minutes, acid–base status, and level of encephalopathy. Apgar scores at 1 minute differed between cohorts. The B3 cohort was all out-born infants reflecting that these two hospitals do not have delivery services.

Missing data were more common in the B3 cohort (see numbers for each variable, ). During the NICHD trial, infants were maintained normothermic and if randomized to hypothermia were placed on a precooled blanket. Following the trial some centers, including the two centers contributing patients to the B3 cohort, implemented cooling during transport. As a result, the mean baseline temperatures were lower for skin and esophageal sites and higher for blanket water among B3 infants. There were 55 infants in the B3 cohort with a baseline esophageal temperature. B2 (n =100) B3 (n =90) p -Value Birth weight (g) n=100 3381±621 n=90 3307±656 0.86 Gestational age (weeks) n=100 39.0±1.6 n=90 38.5±1.8 0.08 Apgar score 1 minute n=99 1 (0–1) n=89 1 (0–2) 0.01 a 5 minute n=99 3 (1–4) n=89 3 (1–4) 0.33 10 minute n=93 4 (3–5) n=83 4 (3–6) 0.26 Blood gas–cord or in 1st hour pH n=71 6.87±0.19 n=83 6.91±0.18 0.87 Base deficit n=61 18.4±6.7 n=60 21±6.82 0.09 Out-born (%) n=100 46% n=90 100%.

Air force dlab requirements. A p-Value is derived from non-parametric median test. And provide data during induction of hypothermia. In view of the wide range of temperatures among the B3 cohort, data for induction are presented for all 90 infants, and three subgroups of B3 infants (Baseline Tes. B2 B3 B3: Baseline T. Tes, esophageal temperature. And provides data during maintenance of hypothermia. Due to the differences in induction of hypothermia, the maintenance phase of cooling, defined as achievement of equilibration to initiation of rewarming at end of 72 hours of cooling, occurred earlier in B3 compared with B2 infants.

Mean Tes and skin temperature were statistically different between cohorts. Blanket temperatures did not differ between cohorts during maintenance reflecting the small differences of skin and Tes between groups. Longitudinal modeling of the temperature gradient between Tes and the blanket water indicated a small difference between Tes and blanket temperature (≈1.2°C, p=0.003), not dependent on the device ( p=0.87), which tended to increase over time (≈1.7°C, p=0.11 for time). The percent of time that Tes remained between 33°C and 34°C was similar between cohorts whether expressed as a mean, 95% confidence interval of the mean, or median and interquartile range. The number of infants with Tes 34°C was greater for B3 compared with B2 but there was no difference in the number of infants with a Tes 34.5°C.

Rewarming was not compared between cohorts due to the similarity of the temperatures. B2 B3 p -Value n 100 90 N/A Postnatal age (hours) at start of maintenance 8.18±4.51 6.83±2.99 ( N=85) 0.0004 Skin temperature, °C (±SD) a 31.8±1.03 32.3±1.13 34°C 15 (15%) 35 (39%) 0.0003 Number of infants with Tes 34.5°C 9 (9%) 13 (14%) 0.27 Number of recorded Tes/infant (x±SD range) 28.4±7.0 1–36 30.2±6.9 6–39 0.008. Discussion With progressive dissemination of therapeutic hypothermia for neonatal hypoxia–ischemia there are an increasing number of devices used to achieve the desired temperature control.

There is a relative paucity of data regarding the extent of temperature control for the “newer” devices that were not used in randomized clinical trials. The precision of temperature control may have an important influence on the extent of neuroprotection and systems that produce as little variation in target temperature are desirable.

The CSZ Blanketrol II was used in the NICHD whole body cooling trial and many centers that have adopted the NICHD protocol use a CSZ device. The Blanketrol III has new temperature modes designed to limit the extent of overshoot during induction of hypothermia, achieve less fluctuation in temperature during maintenance of hypothermia, and avoid the need to circulate water through a second blanket. There are no published data comparing temperature control for the two Blanketrol devices. The results from this report indicate that the ability to maintain Tes within the target range of 33°C–34°C was similar for the Blanketrol II and III. The average Tes value was equal to the target temperature (B3) or within 0.1°C of the target (B2). The small but statistically different skin temperature and Tes between the B2 and B3 cohorts are not likely to be clinically meaningful. The number of infants with Tes below 33°C was greater with the Blanketrol II while the number of infants with Tes above 34°C was greater with the Blanketrol III.

Although it is desirable to have all Tes within the target range, the average percent time outside of the target range was only 5% for B2 and 4% for B3 cohorts. Whether this extent of time outside of the target Tes range affects the extent of neuroprotection is not known. For Tes values out of range it is unclear whether it is more advantageous to have Tes values lower than 33°C (more frequent with B2) or Tes values above 34°C (more frequent with B3). The extent of temperature overshoot and time to equilibration at the target temperature from baseline was less among the B3 cohort. However, the results from this study cannot determine whether differences in the temperature profile during induction of hypothermia reflect the newer temperature control modes of the Blanketrol III or cooling on transport in the B3 cohort. It remains unclear whether the extent of temperature overshoot during induction of hypothermia with the Blanketrol II is deleterious or potentially advantageous.

Of note there were no additional adverse events among infants in the NICHD whole body cooling trial who had Tes values. Azzopardi D, Strohm B, Linsell L, Hobson A, Juszczak E, Kurinczuk JJ, Brocklehurst P, Edwards AD.

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Blanketrol Ii Model 222 Service Manual

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