The Crit-Line IV monitor provides clinicians with real-time information about blood volume (BV) changes during dialysis. This includes the dynamics of BV changes as described in Profiles A, B and C as well as the plasma refill rate which can be performed during or at the end of dialysis treatment. The Crit-Line IV monitor further measures oxygen saturation. The Crit-Line IV monitor must always be used in conjunction with clinical assessment and the patient's existing medical history before altering a dialysis treatment.

Profile A

PROFILE GUIDE

Profile A will be displayed when the measurements taken over the previous 15 minutes result in a profile that is ≤-3% per hour.

This profile is represented as a flat or positive slope. This indicates that the patient’s plasma refill rate is occurring at the same or greater rate than the ultrafiltration rate. Profile A suggests that the ultrafiltration rate might be increased without immediate intradialytic symptoms.

Profile B will be displayed when the measurements taken over the previous 15 minutes result in a profile that is >-3% per hour and ≤-6.5 % per hour.

A Profile B, or gradual slope, has been targeted to find the best compromise between a high ultrafiltration rate and the prevention of intradialytic symptoms. The ideal slope is not a fixed percentage of change in BV, and will vary from patient to patient.

Profile C will be displayed when the measurements taken over the previous 15 minutes result in a profile that is >-6.5% per hour. If the measurements taken over the previous 15 minutes result in a percent blood volume change greater than -8% per hour, then the message "-ΔBV% greater than 8%/hr" will appear.

Represented as a steep slope, this profile indicates a rapid decrease in blood volume and bears a higher risk for intradialytic symptoms.

Profile B

Profile C

CRI

T-LIN

E® IV

MO

NITO

R P

ROFIL

E G

UID

E IV

InterstitialFluid

IntravascularSpace Interstitial

Fluid

IntracellularSpace

InterstitialFluid

IntravascularSpace

InterstitialFluid

IntracellularSpace

InterstitialFluid

InterstitialFluid

IntracellularSpace

IntravascularSpace

© 2015, Fresenius Medical Care, All Rights Reserved. Fresenius Medical Care, the triangle logo, Fresenius Renal Technologies, and Crit-Line are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 102465-01 Rev B 12/2015

Indications for Use: The Crit-Line IV monitor is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The sensor clip measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting. The Crit-Line blood chamber is a sterile, single use, disposable, optical cuvette designed for use with the Crit-Line sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during the hemodialysis treatment. Caution: Federal (US) law restricts this device to sale by or on the order of a physician.

Note: Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling at www.fmcna.com.

Assesment of Plasma Refill

Arterial Oxygen Saturation Venous of Oxygen Saturation

1. Reduce UF rate to minimum (300 ml/hr)2. Record Hct (H1), wait 10 minutes3. Record Hct value (H2)4. If H1-H2 ≥0.5, patient has refill, indicating that additional fluid may be available for removal. 5. If H1-H2 is <0.5, no vascular refill is present.

CRI

T-LIN

E® Q

UIC

KSTA

RT

TIME 03:37 HCT 30.7 BVΔ -0.0 SAT 94

5

0

BVΔ

-10

-20

TIME 04:00 HCT 37.4 BVΔ -13.0 SAT 91

5

0

BVΔ

-10

-20

TIME 04:00 HCT 34.7 BVΔ -12.6 SAT 94

5

0

BVΔ

-10

-20

TIME (hours)

UFMIN

% B

V C

HA

NG

E

0 1 2 3 4

5

0

-5

-10

-15

-20

TIME (hours)

OX

YG

EN S

ATU

RA

TIO

N

0 1 2 3 4

95

90

85

80

TIME (hours)

OX

YG

EN S

ATU

RA

TIO

N

0 1 2 3 4

65

60

55

50

With the ultrafiltration rate above minimum, a flat or positive profile indicates that the patient’s Plasma Refill Rate is occurring at the same or a greater rate than ultrafiltration. BV Profile A suggests that the ultrafiltration rate might be increased without immediate risk of intradialytic symptoms.

A gradual slope has been targeted to find the best compromise between a high ultrafiltration rate and the prevention of intradialytic symptoms. The ideal slope is not a fixed percentage of BV decrease, and will vary from patient to patient. Typical published values seem to range from –1.33%/h to –8%/h depending on patient characteristics and algorithm. Published algorithm in chronic hemodi-alysis patients suggest a BV change of up to ≤ –8%/h in the 1st hour, with an additional BV change of < –4%/h in the following hours, up to a maximum total BV change of –16% at the end of a 3–4 hour dialysis. 1, 2, 3 Another study suggests a minimal average BV change of > –1.33%/h over four hours to be favorable. 4

1. Turn ultrafiltration off or reduce to minimum ultrafiltration rate.2. Record Hct value3. Wait 10 minutes4. Record Hct value5. If Hct value has decreased by ≥0.5, refill is present, indicating that additional

fluid might be available for removal6. If Hct has decreased by <0.5, no post-dialytic vascular refill is present. Extra-

cellular fluid is not shifting to the vascular compartment, indicating that addi-tional fluid removal without increased risk of intradialytic symptoms is limited.

Assessment of Low Arterial Oxygen SaturationFrom graft or fistulaNormal Range > 90%

Assessment of Low Mixed Venous Oxygen SaturationFrom catheterNormal Range 60-80%

A steep slope represents a rapid decrease in blood volume whichbears a higher risk for intradialytic symptoms. Literature indicates that this might occur at a BV change of > –8%/h 1, 3, 5, 6 or at a total BV change of –16% at the end of a 3-4 hour dialysis. 1, 2, 3 However some patients may have a lower or higher tolerance depending on cardiovas-cular status and other comorbidities.

Points to Consider1. Follow facility standard

rescuscitation protocol2. Decrease goal to minimum

ultrafiltration rate3. Perform a thorough clinical

evaluation of the patient

4. Assess oxygen saturation5. Record maximum hematocrit

and consider modifying hematocrit limit

6. Reassess target weight7. Reassess patient medications

and other potential root causes

BV Profile A - Flat or Positive Slope

BV Profile B - Gradual Slope

BV Profile C - Steep Slope

Arterial Oxygen Saturation

Assessment of Plasma Refill

Venous Oxygen Saturation

Assessment of Crash SymptomsCramping, NauseaVomiting, Lightheadedness,Hypotension

Crit-Line Monitor provides the clinician with real-time information about Blood Volume (BV) changes during dialysis. This includes the dynamics of BV changes as described in profile A, B and C as well as the plasma refill rate at the end of dialysis. Crit-Line Monitor further measures oxygen saturation. All Crit-Line Monitor parameters must be considered in conjunction with the patient’s clinical assessment, comorbidities and existing medical history before prescribing or changing a dialysis treatment.

Assesment of Low Arterial Oxygen SaturationFrom graft or fistula: normal range ≥90%

Assesment of Low Mixed Venous Oxygen SaturationFrom catheter: normal range 60–80%

Assesment of Crash SymptomsCramping, Nausea, Vomiting, Lightheadedness, Hypotension

Points to Consider1. Follow facility standard rescuscitation protocol2. Decrease goal to minimum ultrafiltration rate3. Perform a thorough clinical evaluation of the patient4. Assess oxygen saturation5. Consider adjusting BV Alert level6. Reassess target weight7. Reassess patient medications and other potential root causes

References1. Rodriguez HJ, Domenici R, Diroll A, Goykhman I, “Assessment of Dry Weight by Monitoring Changes in Blood Volume During Hemodialysis Using Crit-Line,” Kidney International 68 (2005):854–861.

2. Goldstein S, Smith C, Currier H, “Non-invasive Interventions to Decrease Hospitalization and Associated Costs for Pediatric Patients Receiving Hemodialysis,” Journal of American Society of Nephrology 14 (2003): 2127–2131.

3. Michael M, Brewer ED, Goldstein SL, “Blood Volume Monitoring to Achieve Target Weight in Pediatric Hemodialysis Patients,” Pediatric Nephrology 19:4 (2004): 432–437.

4. Sinha AD, Light RP, Agarwal R, “Relative Plasma Volume Monitoring During Hemodialysis Aids the Assessment of Dry Weight,” Hypertension 55(2010): 305-3110.

5. Reddan, DN, Szczech, LA et al, “Intradialytic Blood Volume Monitoring in Ambulatory Hemodialysis Patients: A Randomized Trial,”Journal of American Socierty of Nephrology 16 (2005): 2162–2169.

6. Jain SR, Smith L, Brewer ED, Goldstein SL. “Non-invasive Intravascular Monitoring in the Pediatric Hemodialysis Population,” Pediatric Nephrology 16:1(2001):15-8.

Fresenius Renal Technologies, a division of Fresenius Medical Care North America920 Winter Street, Waltham, MA 02451 • www.fmcna-crit-line.comCustomer Service: 800-323-5188 • Technical Support: 800-227-2572